<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990338</url>
  </required_header>
  <id_info>
    <org_study_id>EFC14335</org_study_id>
    <secondary_id>2016-003097-41</secondary_id>
    <secondary_id>U1111-1180-6262</secondary_id>
    <nct_id>NCT02990338</nct_id>
  </id_info>
  <brief_title>Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients</brief_title>
  <acronym>ICARIA-MM</acronym>
  <official_title>A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose&#xD;
      dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to&#xD;
      pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and&#xD;
      refractory multiple myeloma (MM).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group&#xD;
           (IMWG) criteria in each arm.&#xD;
&#xD;
        -  To compare the Overall Survival (OS) between the two arms.&#xD;
&#xD;
        -  To evaluate the Time To Progression (TTP) in each arm.&#xD;
&#xD;
        -  To evaluate the PFS in high risk cytogenetic population in each arm.&#xD;
&#xD;
        -  To evaluate the Duration of Response (DOR) in each arm.&#xD;
&#xD;
        -  To evaluate the safety in both treatment arms.&#xD;
&#xD;
        -  To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.&#xD;
&#xD;
        -  To evaluate the immunogenicity of isatuximab.&#xD;
&#xD;
        -  To assess disease-specific and generic health-related quality of life (HRQL), disease&#xD;
           and treatment-related symptoms, health state utility, and health status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of the study for the participants included a period for screening of up to 21&#xD;
      days (or up to 28 days for women who can become pregnant). Participants continued study&#xD;
      treatment until disease progression, unacceptable adverse reaction, participants' wish or&#xD;
      other reason of discontinuation.&#xD;
&#xD;
      During follow-up, participants who discontinued the study treatment due to progression of the&#xD;
      disease were followed every 3 months (12 weeks) for survival (or until cut-off date), and&#xD;
      participants who discontinued the study treatment prior to documentation of disease&#xD;
      progression were followed-up every 4 weeks until disease progression, and then every 3 months&#xD;
      (12 weeks) for survival (or until cut-off date).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Anticipated">June 27, 2024</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)</time_frame>
    <description>PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of &gt;=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;=0.5gram(g)/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL; urine M-component (absolute increase must be &gt;=200mg/24hour), appearance of new lesion(s),&gt;=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h/,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h,if present at baseline,&gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h. MR:&gt;=25% but &lt;=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Very Good Partial Response (VGPR) or Better as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or &gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100 mg/24 h or &gt;=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as &gt;= 25% but &lt;= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, &gt;=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS): Final Analysis</measure>
    <time_frame>From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)</time_frame>
    <description>OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP) as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of &gt;= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;= 0.5 g/dL), serum M-protein increase &gt;=1 g/dL if the lowest M component was &gt;=5 g/dL; urine M-component (the absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival in High Risk Cytogenetic Population</measure>
    <time_frame>From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1 g/dL if lowest M component was &gt;=5 g/dL; urine M-component (absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of previous lesion &gt;1 centimeter (cm) in short axis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) as Per Independent Response Committee</measure>
    <time_frame>From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)</time_frame>
    <description>DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL;urine M-component (absolute increase must be &gt;=200mg/24 hour),appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion,or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 cm in short axis. PR:&gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Response (TT1R) as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Best Response (TTBR) as Per Independent Response Committee</measure>
    <time_frame>From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
    <description>TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Minimal Residual Disease (MRD)</measure>
    <time_frame>Up to 76.7 weeks</time_frame>
    <description>MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and &lt;5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)</time_frame>
    <description>Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)</measure>
    <time_frame>End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1</time_frame>
    <description>CEOI was defined as the plasma concentration at end of infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)</measure>
    <time_frame>End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1</time_frame>
    <description>Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)</measure>
    <time_frame>Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1</time_frame>
    <description>CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Plasma Concentration of Isatuximab at Ctrough</measure>
    <time_frame>Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])</time_frame>
    <description>Trough Concentration (Ctrough) is the concentration prior to study drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)</measure>
    <time_frame>Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1</time_frame>
    <description>Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-drug Antibodies (ADA)</measure>
    <time_frame>From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)</time_frame>
    <description>ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score</measure>
    <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
    <description>EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score</measure>
    <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
    <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score</measure>
    <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
    <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value</measure>
    <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
    <description>The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)</measure>
    <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
    <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">307</enrollment>
  <condition>Plasma Cell Myeloma</condition>
  <arm_group>
    <arm_group_label>Pd (pomalidomide + dexamethasone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants greater than or equal to (&gt;=) 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPd (isatuximab + pomalidomide + dexamethasone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isatuximab</intervention_name>
    <description>Pharmaceutical form: solution for infusion Route of administration: intravenous</description>
    <arm_group_label>IPd (isatuximab + pomalidomide + dexamethasone)</arm_group_label>
    <other_name>SAR650984</other_name>
    <other_name>Sarclisa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Pharmaceutical form: capsule Route of administration: oral</description>
    <arm_group_label>IPd (isatuximab + pomalidomide + dexamethasone)</arm_group_label>
    <arm_group_label>Pd (pomalidomide + dexamethasone)</arm_group_label>
    <other_name>POMALYST IMNOVID</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous</description>
    <arm_group_label>IPd (isatuximab + pomalidomide + dexamethasone)</arm_group_label>
    <arm_group_label>Pd (pomalidomide + dexamethasone)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Age superior or equal to 18 years or country's legal age of majority if the legal age&#xD;
             was superior to 18 years old.&#xD;
&#xD;
          -  Participants had a documented diagnosis of multiple myeloma with evidence of&#xD;
             measurable disease i.e. serum M protein superior or equal to 0.5 grams per decilitre&#xD;
             (g/dL) measured using serum protein immunoelectrophoresis and or urine M protein&#xD;
             superior or equal to 200 mg per 24 hours measured using urine protein&#xD;
             immunoelectrophoresis.&#xD;
&#xD;
          -  Participants had received at least 2 prior lines of anti-myeloma therapy, which must&#xD;
             include at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor&#xD;
             (bortezomib, carfilzomib or ixazomib) given alone or in combination.&#xD;
&#xD;
          -  Participants had failed treatment with lenalidomide and a proteasome inhibitor&#xD;
             (bortezomib, carfilzomib, or ixazomib) alone or in combination (Intolerant,&#xD;
             progression within 6 months after reaching Partial Response or better).&#xD;
&#xD;
          -  Participants had progressed on or within 60 days after end of previous therapy before&#xD;
             to study entry, i.e., refractory to the last line of treatment.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Primary refractory multiple myeloma defined as participants who had never achieved at&#xD;
             least a minimal response (MR) with any treatment during the disease course.&#xD;
&#xD;
          -  Free Light Chain measurable disease only.&#xD;
&#xD;
          -  Prior therapy with pomalidomide.&#xD;
&#xD;
          -  Any anti-myeloma drug treatment within 14 days before randomization, including&#xD;
             dexamethasone.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status superior to 2.&#xD;
&#xD;
          -  Platelets inferior to 75 000 cells per microliter (mcL) if inferior to 50% of bone&#xD;
             marrow (BM) nucleated cells are plasma cells, and inferior to 30 000 cells per mcL if&#xD;
             superior or equal to 50% of BM nucleated cells are plasma cells. Platelet transfusion&#xD;
             was not allowed within three days before the screening visit.&#xD;
&#xD;
          -  Absolute neutrophil count inferior to 1000 per mcL (1*10^9/L).&#xD;
&#xD;
          -  Creatinine clearance inferior to 30 mL per minute (Modification of Diet in Renal&#xD;
             Disease [MDRD] Formula).&#xD;
&#xD;
          -  Total bilirubin superior to 2*ULN (Upper Limit of Normal).&#xD;
&#xD;
          -  Corrected serum calcium superior to 14 milligrams per deciliter (mg/dL) (superior to&#xD;
             3.5 millimoles per liter (mmol/L).&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) superior to&#xD;
             3*ULN.&#xD;
&#xD;
          -  Hypersensitivity to immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide)&#xD;
             defined as any hypersensitivity reaction leading to stop IMiDs within the 2 first&#xD;
             cycles or toxicity, which does meet intolerance definition.&#xD;
&#xD;
          -  Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt),&#xD;
             and polysorbate 80 or any of the components of study therapy that are not amenable to&#xD;
             premedication with steroids, or H2 blockers that would prohibit further treatment with&#xD;
             these agents.&#xD;
&#xD;
          -  Significant cardiac dysfunction; myocardial infarction within 12 months; unstable,&#xD;
             poorly controlled angina pectoris.&#xD;
&#xD;
          -  Pregnant or breastfeeding woman or female who intends to become pregnant during the&#xD;
             participation in the study.&#xD;
&#xD;
          -  Male participants who disagreed to practice true abstinence or disagreed to use a&#xD;
             condom during sexual contact with a pregnant female or a female of childbearing&#xD;
             potential while participating in the study, during dose interruptions and at least 3&#xD;
             or 5 months following study treatment discontinuation, even if he had undergone a&#xD;
             successful vasectomy.&#xD;
&#xD;
          -  All participants who disagreed to refrain from donating blood while on study treatment&#xD;
             and for 4 weeks after discontinuation from this study treatment.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number :8400002</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8400006</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360004</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360001</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360005</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360002</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0360006</name>
      <address>
        <city>Richmond</city>
        <state>Victoria</state>
        <zip>3121</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560003</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560002</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560004</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :0560001</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240001</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240004</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1240005</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030005</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030004</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030001</name>
      <address>
        <city>Olomouc</city>
        <zip>77900</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030002</name>
      <address>
        <city>Ostrava - Poruba</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2030003</name>
      <address>
        <city>Praha 2</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2080002</name>
      <address>
        <city>Ålborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500021</name>
      <address>
        <city>Bayonne</city>
        <zip>64100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500008</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500009</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500017</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500013</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500003</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500023</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500019</name>
      <address>
        <city>Montpellier Cedex</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500002</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500015</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500016</name>
      <address>
        <city>Paris</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500005</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500004</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500007</name>
      <address>
        <city>POITIERS Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500025</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500014</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500001</name>
      <address>
        <city>TOULOUSE Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500012</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2500018</name>
      <address>
        <city>Vandoeuvre-les-nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :2760001</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000002</name>
      <address>
        <city>Athens</city>
        <zip>106 76</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000005</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000001</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000004</name>
      <address>
        <city>Patra</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3000003</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480001</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480003</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3480002</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800001</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800010</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800009</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800008</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800007</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800002</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800006</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800004</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3800003</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920001</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920005</name>
      <address>
        <city>Shibukawa-shi</city>
        <state>Gunma</state>
        <zip>377-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920004</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920006</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>603-8151</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920008</name>
      <address>
        <city>Suwa-shi</city>
        <state>Nagano</state>
        <zip>392-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920003</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920007</name>
      <address>
        <city>Sunto-gun</city>
        <state>Shizuoka</state>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :3920002</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo</state>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100007</name>
      <address>
        <city>Hwasun-gun</city>
        <state>Jeollanam-do</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100001</name>
      <address>
        <city>Seoul</city>
        <state>Seoul-teukbyeolsi</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100002</name>
      <address>
        <city>Seoul</city>
        <state>Seoul-teukbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100006</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :4100005</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5540001</name>
      <address>
        <city>Takapuna</city>
        <state>Auckland</state>
        <zip>1309</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5540004</name>
      <address>
        <city>Dunedin</city>
        <state>Otago</state>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5540003</name>
      <address>
        <city>Hamilton</city>
        <state>Waikato</state>
        <zip>3204</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5540002</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :5780001</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160003</name>
      <address>
        <city>Lublin</city>
        <state>Lubuskie</state>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160005</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160001</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6160002</name>
      <address>
        <city>Chorzow</city>
        <state>Slaskie</state>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200004</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200002</name>
      <address>
        <city>Lisboa</city>
        <zip>1070</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6200001</name>
      <address>
        <city>Porto</city>
        <zip>4200</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430004</name>
      <address>
        <city>Moscow</city>
        <zip>125167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430001</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :6430002</name>
      <address>
        <city>Moscow</city>
        <zip>129301</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7030001</name>
      <address>
        <city>Bratislava</city>
        <zip>83310</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240005</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña [La Coruña]</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240001</name>
      <address>
        <city>Barcelona</city>
        <state>Barcelona [Barcelona]</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240006</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240002</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240003</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7240004</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7520004</name>
      <address>
        <city>Luleå</city>
        <zip>97180</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7520005</name>
      <address>
        <city>Uddevalla</city>
        <zip>451 80</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1580004</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1580002</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1580001</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :1580003</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920001</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920002</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920005</name>
      <address>
        <city>Istanbul</city>
        <zip>34010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920006</name>
      <address>
        <city>Istanbul</city>
        <zip>34381</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920003</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920004</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920008</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920010</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920009</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :7920007</name>
      <address>
        <city>Kocaeli</city>
        <zip>41400</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260002</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260003</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number :8260001</name>
      <address>
        <city>London</city>
        <zip>WC1E6AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum In: Lancet. 2019 Dec 7;394(10214):2072.</citation>
    <PMID>31735560</PMID>
  </reference>
  <reference>
    <citation>Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161. Lancet Oncol. 2022 Sep;23(9):e404.</citation>
    <PMID>35151415</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>November 19, 2019</results_first_submitted>
  <results_first_submitted_qc>November 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 6, 2019</results_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anti-CD38 monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02990338/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02990338/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 102 sites in 24 countries. A total of 387 participants were screened between 22 December 2016 and 01 February 2018. Out of which, 307 participants were randomized in 1:1 ratio to IPd (Isatuximab + Pomalidomide + Dexamethasone) and Pd (Pomalidomide + Dexamethasone) arms using an interactive response technology (IRT).</recruitment_details>
      <pre_assignment_details>Randomization was stratified by age (less than [&lt;] 75 years versus greater than and equal to [&gt;=] 75 years) and number of previous lines of therapy (2 or 3 versus more than 3). The current results are updated to report the final OS analysis and safety and participant flow data based on a data cut-off date of 14 March 2022. A few participants are still on treatment in the Pd and IPd arm who are being monitored for safety assessments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pd (Pomalidomide + Dexamethasone)</title>
          <description>Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
        </group>
        <group group_id="P2">
          <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
          <description>Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.</population>
      <group_list>
        <group group_id="B1">
          <title>Pd (Pomalidomide + Dexamethasone)</title>
          <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
        </group>
        <group group_id="B2">
          <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
          <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="153"/>
            <count group_id="B2" value="154"/>
            <count group_id="B3" value="307"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.2" spread="9.5"/>
                    <measurement group_id="B2" value="66.6" spread="9.1"/>
                    <measurement group_id="B3" value="65.9" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of &gt;=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;=0.5gram(g)/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL; urine M-component (absolute increase must be &gt;=200mg/24hour), appearance of new lesion(s),&gt;=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)</time_frame>
        <population>Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of &gt;=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;=0.5gram(g)/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL; urine M-component (absolute increase must be &gt;=200mg/24hour), appearance of new lesion(s),&gt;=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
          <population>Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.47" lower_limit="4.468" upper_limit="8.279"/>
                    <measurement group_id="O2" value="11.53" lower_limit="8.936" upper_limit="13.897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.</non_inferiority_desc>
            <p_value>0.0005</p_value>
            <p_value_desc>One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>Stratification was based on age (&lt;75 years versus &gt;=75 years) and number of previous lines of therapy (2 or 3 versus &gt;3) according to IRT.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.596</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.436</ci_lower_limit>
            <ci_upper_limit>0.814</ci_upper_limit>
            <estimate_desc>Stratification was based on age (&lt;75 years versus &gt;=75 years) and number of previous lines of therapy (2 or 3 versus &gt;3) according to IRT.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)</title>
        <description>ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h/,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h,if present at baseline,&gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)</title>
          <description>ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h/,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h,if present at baseline,&gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3"/>
                    <measurement group_id="O2" value="60.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for statistical significance at 0.025.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>One sided p-value was stratified based on age (&lt;75 years versus &gt;=75 years) and number of previous lines (2 or 3 versus &gt;3) according to IRT.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee</title>
        <description>BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h. MR:&gt;=25% but &lt;=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.</description>
        <time_frame>From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee</title>
          <description>BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,&gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100mg/24h,&gt;=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: &gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h. MR:&gt;=25% but &lt;=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stringent complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very good partial response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                    <measurement group_id="O2" value="27.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimal response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                    <measurement group_id="O2" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4"/>
                    <measurement group_id="O2" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                    <measurement group_id="O2" value="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                    <measurement group_id="O2" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Very Good Partial Response (VGPR) or Better as Per Independent Response Committee</title>
        <description>VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or &gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100 mg/24 h or &gt;=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Very Good Partial Response (VGPR) or Better as Per Independent Response Committee</title>
          <description>VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or &gt;=90% reduction in serum M-protein plus urine M-protein level &lt;100 mg/24 h or &gt;=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,&lt;5% plasma cells in bone marrow aspirates.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5"/>
                    <measurement group_id="O2" value="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit as Per Independent Response Committee</title>
        <description>CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as &gt;= 25% but &lt;= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, &gt;=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit as Per Independent Response Committee</title>
          <description>CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as &gt;= 25% but &lt;= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, &gt;=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4"/>
                    <measurement group_id="O2" value="66.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS): Final Analysis</title>
        <description>OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.</description>
        <time_frame>From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS): Final Analysis</title>
          <description>OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.71" lower_limit="14.390" upper_limit="26.218"/>
                    <measurement group_id="O2" value="24.57" lower_limit="20.304" upper_limit="31.310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.</non_inferiority_desc>
            <p_value>0.0319</p_value>
            <p_value_desc>One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>Stratified on age (&lt;75 years versus &gt;=75 years) and number of previous lines of therapy (2 or 3 versus &gt; 3) according to IRT.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.776</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.594</ci_lower_limit>
            <ci_upper_limit>1.015</ci_upper_limit>
            <estimate_desc>Stratified on age (&lt;75 years versus &gt;=75 years) and number of previous lines of therapy (2 or 3 versus &gt; 3) according to IRT.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression (TTP) as Per Independent Response Committee</title>
        <description>TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of &gt;= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;= 0.5 g/dL), serum M-protein increase &gt;=1 g/dL if the lowest M component was &gt;=5 g/dL; urine M-component (the absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression (TTP) as Per Independent Response Committee</title>
          <description>TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of &gt;= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be &gt;= 0.5 g/dL), serum M-protein increase &gt;=1 g/dL if the lowest M component was &gt;=5 g/dL; urine M-component (the absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 centimeter in short axis.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.75" lower_limit="5.027" upper_limit="9.758"/>
                    <measurement group_id="O2" value="12.71" lower_limit="11.203" upper_limit="15.211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival in High Risk Cytogenetic Population</title>
        <description>PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1 g/dL if lowest M component was &gt;=5 g/dL; urine M-component (absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of previous lesion &gt;1 centimeter (cm) in short axis.</description>
        <time_frame>From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival in High Risk Cytogenetic Population</title>
          <description>PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1 g/dL if lowest M component was &gt;=5 g/dL; urine M-component (absolute increase must be &gt;=200 mg/24hour), appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion, or &gt;=50% increase in the longest diameter of previous lesion &gt;1 centimeter (cm) in short axis.</description>
          <population>Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.745" lower_limit="2.793" upper_limit="7.885"/>
                    <measurement group_id="O2" value="7.491" lower_limit="2.628" upper_limit="NA">Due to smaller number of participants with an event, 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) as Per Independent Response Committee</title>
        <description>DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL;urine M-component (absolute increase must be &gt;=200mg/24 hour),appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion,or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 cm in short axis. PR:&gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h.</description>
        <time_frame>From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on responders in ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) as Per Independent Response Committee</title>
          <description>DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of &gt;=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be &gt;=0.5 g/dL), serum M-protein increase &gt;=1g/dL if lowest M component was &gt;=5g/dL;urine M-component (absolute increase must be &gt;=200mg/24 hour),appearance of new lesion(s), &gt;=50% increase from nadir in SPD of &gt;1 lesion,or &gt;=50% increase in the longest diameter of a previous lesion &gt;1 cm in short axis. PR:&gt;=50% reduction of serum M-protein and reduction in 24h urinary M-protein by &gt;=90%/&lt;200mg/24h.</description>
          <population>Analysis was performed on responders in ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.07" lower_limit="8.542" upper_limit="NA">Due to smaller number of participants with an event, 95% CI could not be calculated.</measurement>
                    <measurement group_id="O2" value="13.27" lower_limit="10.612" upper_limit="NA">Due to smaller number of participants with an event, 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Response (TT1R) as Per Independent Response Committee</title>
        <description>TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.</description>
        <time_frame>From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Response (TT1R) as Per Independent Response Committee</title>
          <description>TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" lower_limit="2.825" upper_limit="5.060"/>
                    <measurement group_id="O2" value="1.94" lower_limit="1.314" upper_limit="2.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Best Response (TTBR) as Per Independent Response Committee</title>
        <description>TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
        <time_frame>From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Best Response (TTBR) as Per Independent Response Committee</title>
          <description>TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as &gt;=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by &gt;=90% or to &lt;200 mg/24 h. In addition to the above listed criteria, if present at baseline, a &gt;=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.</description>
          <population>Analysis was performed on ITT population.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" lower_limit="3.778" upper_limit="7.885"/>
                    <measurement group_id="O2" value="4.30" lower_limit="2.891" upper_limit="5.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Minimal Residual Disease (MRD)</title>
        <description>MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and &lt;5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.</description>
        <time_frame>Up to 76.7 weeks</time_frame>
        <population>Analysis was performed on ITT population who were evaluable for MRD.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Minimal Residual Disease (MRD)</title>
          <description>MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and &lt;5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.</description>
          <population>Analysis was performed on ITT population who were evaluable for MRD.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MRD negative:1 in 10^4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRD negative:1 in 10^5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRD negative:1 in 10^6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRD positive:1 in 10^4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRD positive:1 in 10^5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MRD positive:1 in 10^6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.</description>
        <time_frame>From randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)</time_frame>
        <population>Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.</description>
          <population>Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any treatment emergent SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE leading to treatment discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)</title>
        <description>CEOI was defined as the plasma concentration at end of infusion.</description>
        <time_frame>End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1</time_frame>
        <population>Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure (OM) was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)</title>
          <description>CEOI was defined as the plasma concentration at end of infusion.</description>
          <population>Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure (OM) was not planned to be collected and analyzed for Pd arm.</population>
          <units>microgram per milliliter (mcg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of infusion: C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.05" spread="34.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of infusion: C1D15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="269.20" spread="32.622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of infusion: C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299.85" spread="35.921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of infusion: C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="279.31" spread="47.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)</title>
        <description>Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.</description>
        <time_frame>End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1</time_frame>
        <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)</title>
          <description>Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.</description>
          <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C2D1 versus C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.860" spread="170.9185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1 versus C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.777" spread="224.2542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)</title>
        <description>CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.</description>
        <time_frame>Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1</time_frame>
        <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)</title>
          <description>CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.</description>
          <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.55" spread="38.299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="294.96" spread="57.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Plasma Concentration of Isatuximab at Ctrough</title>
        <description>Trough Concentration (Ctrough) is the concentration prior to study drug administration.</description>
        <time_frame>Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])</time_frame>
        <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Plasma Concentration of Isatuximab at Ctrough</title>
          <description>Trough Concentration (Ctrough) is the concentration prior to study drug administration.</description>
          <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="1194.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.49" spread="53.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.89" spread="54.764"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.82" spread="57.666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.09" spread="60.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.35" spread="61.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.15" spread="76.469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.73" spread="78.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.05" spread="70.062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.42" spread="68.035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C5D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.08" spread="65.275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C6D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.33" spread="64.985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C7D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.14" spread="60.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C8D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.15" spread="55.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C9D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162.84" spread="65.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C10D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.86" spread="60.719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C11D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.39" spread="56.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C12D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.32" spread="56.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C13D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215.85" spread="54.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C14D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.88" spread="55.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C15D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253.61" spread="58.885"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C16D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206.60" spread="50.965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C17D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242.79" spread="45.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C18D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.70" spread="58.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C19D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240.36" spread="42.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C20D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.51" spread="136.883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)</title>
        <description>Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.</description>
        <time_frame>Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1</time_frame>
        <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)</title>
          <description>Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.</description>
          <population>Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C2D1 versus C1D8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.689" spread="734.5547"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1 versus C1D8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.620" spread="645.4171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-drug Antibodies (ADA)</title>
        <description>ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.</description>
        <time_frame>From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)</time_frame>
        <population>Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IPd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
        <group_list>
          <group group_id="O1">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-drug Antibodies (ADA)</title>
          <description>ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.</description>
          <population>Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IPd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this OM was not planned to be collected and analyzed for Pd arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-existing ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment induced ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score</title>
        <description>EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.</description>
        <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
        <population>Analysis was performed on safety population evaluable for global health status. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score</title>
          <description>EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.</description>
          <population>Analysis was performed on safety population evaluable for global health status. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.19" spread="20.64"/>
                    <measurement group_id="O2" value="60.10" spread="20.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.45" spread="21.03"/>
                    <measurement group_id="O2" value="-1.22" spread="22.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="22.26"/>
                    <measurement group_id="O2" value="-0.16" spread="18.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="19.97"/>
                    <measurement group_id="O2" value="0.41" spread="20.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.17" spread="24.36"/>
                    <measurement group_id="O2" value="-1.92" spread="19.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score</title>
        <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL</description>
        <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
        <population>Analysis was performed on safety population evaluable for disease symptoms. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score</title>
          <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL</description>
          <population>Analysis was performed on safety population evaluable for disease symptoms. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.91" spread="20.67"/>
                    <measurement group_id="O2" value="24.12" spread="20.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.79" spread="16.09"/>
                    <measurement group_id="O2" value="-2.07" spread="17.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.08" spread="17.95"/>
                    <measurement group_id="O2" value="-3.30" spread="16.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.83" spread="15.04"/>
                    <measurement group_id="O2" value="-4.66" spread="13.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.33" spread="15.54"/>
                    <measurement group_id="O2" value="0.00" spread="21.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score</title>
        <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.</description>
        <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
        <population>Analysis was performed on safety population evaluable for side effects of treatment. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score</title>
          <description>EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.</description>
          <population>Analysis was performed on safety population evaluable for side effects of treatment. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.49" spread="15.25"/>
                    <measurement group_id="O2" value="15.60" spread="11.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="11.54"/>
                    <measurement group_id="O2" value="2.61" spread="13.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="15.10"/>
                    <measurement group_id="O2" value="2.11" spread="11.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="14.66"/>
                    <measurement group_id="O2" value="3.14" spread="11.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.93" spread="15.94"/>
                    <measurement group_id="O2" value="3.02" spread="15.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value</title>
        <description>The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
        <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
        <population>Analysis was performed on safety population evaluable for health state utility index. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value</title>
          <description>The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.</description>
          <population>Analysis was performed on safety population evaluable for health state utility index. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.24"/>
                    <measurement group_id="O2" value="0.71" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.22"/>
                    <measurement group_id="O2" value="-0.01" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.22"/>
                    <measurement group_id="O2" value="-0.00" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.27"/>
                    <measurement group_id="O2" value="-0.01" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.19"/>
                    <measurement group_id="O2" value="-0.01" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)</title>
        <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
        <time_frame>Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)</time_frame>
        <population>Analysis was performed on safety population evaluable for visual analogue scale. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Pd (Pomalidomide + Dexamethasone)</title>
            <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 73.7 weeks).</description>
          </group>
          <group group_id="O2">
            <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
            <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)</title>
          <description>EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.</description>
          <population>Analysis was performed on safety population evaluable for visual analogue scale. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.38" spread="19.31"/>
                    <measurement group_id="O2" value="66.62" spread="19.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="17.37"/>
                    <measurement group_id="O2" value="0.92" spread="19.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="18.83"/>
                    <measurement group_id="O2" value="1.19" spread="17.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.42" spread="19.78"/>
                    <measurement group_id="O2" value="1.96" spread="16.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Cycle 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.70" spread="12.39"/>
                    <measurement group_id="O2" value="-3.00" spread="12.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data was collected from the time of first dose of study drug administration up to 30 days following the last administration of study treatment (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)</time_frame>
      <desc>Reported AEs and deaths are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). All-Cause Mortality was assessed for all randomized participants, Serious and Other Adverse Events were collected for safety population only.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pd (Pomalidomide + Dexamethasone)</title>
          <description>Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).</description>
        </group>
        <group group_id="E2">
          <title>IPd (Isatuximab + Pomalidomide + Dexamethasone)</title>
          <description>Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants &gt;= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="115" subjects_at_risk="153"/>
                <counts group_id="E2" subjects_affected="109" subjects_at_risk="154"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hyperviscosity Syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Splenic Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Arrhythmia Supraventricular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis Coronary Artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diastolic Dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Colitis Ischaemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diverticular Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Large Intestine Perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Disease Progression</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Influenza Like Illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Atypical Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Covid-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Covid-19 Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Candida Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cellulitis Staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Coronavirus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus Gastrointestinal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Device Related Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Ear, Nose And Throat Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Escherichia Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Gastroenteritis Enteroviral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Haemophilus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Herpes Zoster Disseminated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lymphangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Medical Device Site Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Meningitis Cryptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Meningitis Listeria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Neurological Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Periorbital Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jirovecii Pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="31" subjects_at_risk="149"/>
                <counts group_id="E2" events="51" subjects_affected="35" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Haemophilus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Influenzal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia Viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pseudomonal Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pseudomonas Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyelonephritis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Soft Tissue Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Systemic Candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Viral Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hepatic Enzyme Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Metabolic Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tumour Lysis Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Osteonecrosis Of Jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Osteoporotic Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Soft Tissue Necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lip Neoplasm Malignant Stage Unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lip Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Metastatic Malignant Melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Myelodysplastic Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma Of Skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tumour Associated Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Basal Ganglia Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cauda Equina Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cerebellar Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Depressed Level Of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Intracranial Aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Spinal Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vith Nerve Paresis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vocal Cord Paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Psychosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Renal Aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diabetic Ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="139" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="145" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="96" subjects_affected="52" subjects_at_risk="149"/>
                <counts group_id="E2" events="182" subjects_affected="77" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="149"/>
                <counts group_id="E2" events="27" subjects_affected="19" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="149"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="35" subjects_affected="30" subjects_at_risk="149"/>
                <counts group_id="E2" events="37" subjects_affected="27" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="44" subjects_affected="32" subjects_at_risk="149"/>
                <counts group_id="E2" events="85" subjects_affected="48" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="149"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="22" subjects_affected="20" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="36" subjects_affected="29" subjects_at_risk="149"/>
                <counts group_id="E2" events="37" subjects_affected="23" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="34" subjects_affected="32" subjects_at_risk="149"/>
                <counts group_id="E2" events="43" subjects_affected="30" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="149"/>
                <counts group_id="E2" events="38" subjects_affected="30" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="149"/>
                <counts group_id="E2" events="27" subjects_affected="22" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="29" subjects_affected="16" subjects_at_risk="149"/>
                <counts group_id="E2" events="65" subjects_affected="37" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="149"/>
                <counts group_id="E2" events="44" subjects_affected="23" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Oral Herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="19" subjects_affected="10" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="149"/>
                <counts group_id="E2" events="29" subjects_affected="18" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="51" subjects_affected="28" subjects_at_risk="149"/>
                <counts group_id="E2" events="119" subjects_affected="53" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="149"/>
                <counts group_id="E2" events="21" subjects_affected="15" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="56" subjects_affected="52" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="23" subjects_affected="17" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="149"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="149"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="149"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="149"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="149"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="149"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="149"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="149"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="149"/>
                <counts group_id="E2" events="22" subjects_affected="14" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="149"/>
                <counts group_id="E2" events="33" subjects_affected="23" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="149"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="149"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi aventis recherche &amp; développement</organization>
      <phone>800-633-1610 ext 6#</phone>
      <email>Contact-US@sanofi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990338
org study id: EFC14335
secondary id: 2016-003097-41
secondary id: U1111-1180-6262
nct id: NCT02990338
lead sponsor: 
has dmc: Yes
Primary Objective:

      To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose
      dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to
      pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and
      refractory multiple myeloma (MM).

      Secondary Objectives:

        -  To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group
           (IMWG) criteria in each arm.

        -  To compare the Overall Survival (OS) between the two arms.

        -  To evaluate the Time To Progression (TTP) in each arm.

        -  To evaluate the PFS in high risk cytogenetic population in each arm.

        -  To evaluate the Duration of Response (DOR) in each arm.

        -  To evaluate the safety in both treatment arms.

        -  To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.

        -  To evaluate the immunogenicity of isatuximab.

        -  To assess disease-specific and generic health-related quality of life (HRQL), disease
           and treatment-related symptoms, health state utility, and health status.
The duration of the study for the participants included a period for screening of up to 21
      days (or up to 28 days for women who can become pregnant). Participants continued study
      treatment until disease progression, unacceptable adverse reaction, participants' wish or
      other reason of discontinuation.

      During follow-up, participants who discontinued the study treatment due to progression of the
      disease were followed every 3 months (12 weeks) for survival (or until cut-off date), and
      participants who discontinued the study treatment prior to documentation of disease
      progression were followed-up every 4 weeks until disease progression, and then every 3 months
      (12 weeks) for survival (or until cut-off date).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)
description: PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of >=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >=0.5gram(g)/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24hour), appearance of new lesion(s),>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.
measure: Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)
time frame: From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h,if present at baseline,>=50% reduction in the size (SPD) of soft tissue plasmacytomas.
measure: Percentage of Participants With Best Overall Response (BOR) as Per Independent Response Committee
time frame: From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: BOR:best sequential response from start of treatment until disease progression, death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response (MR), stable disease (SD), PD, and not evaluable.CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h. MR:>=25% but <=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better as Per Independent Response Committee
time frame: From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h or >=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.
measure: Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit as Per Independent Response Committee
time frame: From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.
measure: Overall Survival (OS): Final Analysis
time frame: From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)
description: OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.
measure: Time to Progression (TTP) as Per Independent Response Committee
time frame: From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of >= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if the lowest M component was >=5 g/dL; urine M-component (the absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.
measure: Progression Free Survival in High Risk Cytogenetic Population
time frame: From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 centimeter (cm) in short axis.
measure: Duration of Response (DOR) as Per Independent Response Committee
time frame: From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)
description: DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL;urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion,or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis. PR:>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h.
measure: Time to First Response (TT1R) as Per Independent Response Committee
time frame: From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
measure: Time to Best Response (TTBR) as Per Independent Response Committee
time frame: From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)
description: TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.
measure: Number of Participants With Minimal Residual Disease (MRD)
time frame: Up to 76.7 weeks
description: MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)
description: Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
measure: Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)
time frame: End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1
description: CEOI was defined as the plasma concentration at end of infusion.
measure: Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)
time frame: End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1
description: Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.
measure: Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)
time frame: Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1
description: CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.
measure: PK Parameter: Plasma Concentration of Isatuximab at Ctrough
time frame: Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT [30 days after last drug administration])
description: Trough Concentration (Ctrough) is the concentration prior to study drug administration.
measure: PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)
time frame: Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1
description: Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.
measure: Number of Participants With Anti-drug Antibodies (ADA)
time frame: From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)
description: ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score
time frame: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
description: EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score
time frame: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
description: EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score
time frame: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
description: EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.
measure: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value
time frame: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
description: The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
measure: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)
time frame: Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)
description: EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
arm group label: Pd (pomalidomide + dexamethasone)
arm group type: Active Comparator
description: Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants greater than or equal to (>=) 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).
arm group label: IPd (isatuximab + pomalidomide + dexamethasone)
arm group type: Experimental
description: Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).
intervention type: Drug
intervention name: Isatuximab
description: Pharmaceutical form: solution for infusion Route of administration: intravenous
arm group label: IPd (isatuximab + pomalidomide + dexamethasone)
other name: SAR650984
other name: Sarclisa
intervention type: Drug
intervention name: Pomalidomide
description: Pharmaceutical form: capsule Route of administration: oral
arm group label: IPd (isatuximab + pomalidomide + dexamethasone)
arm group label: Pd (pomalidomide + dexamethasone)
other name: POMALYST IMNOVID
intervention type: Drug
intervention name: Dexamethasone
description: Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous
arm group label: IPd (isatuximab + pomalidomide + dexamethasone)
arm group label: Pd (pomalidomide + dexamethasone)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Australia
country: Belgium
country: Canada
country: Czechia
country: Denmark
country: France
country: Germany
country: Greece
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: New Zealand
country: Norway
country: Poland
country: Portugal
country: Russian Federation
country: Slovakia
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
citation: Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Mace S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum In: Lancet. 2019 Dec 7;394(10214):2072.
PMID: 31735560
citation: Richardson PG, Perrot A, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Malinge L, Dubin F, van de Velde H, Anderson KC. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study. Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161. Lancet Oncol. 2022 Sep;23(9):e404.
PMID: 35151415
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Pomalidomide
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 