<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/NCT02195479</url>
  </required_header>
  <id_info>
    <org_study_id>CR104761</org_study_id>
    <secondary_id>54767414MMY3007</secondary_id>
    <secondary_id>2014-002272-88</secondary_id>
    <nct_id>NCT02195479</nct_id>
  </id_info>
  <brief_title>A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma</brief_title>
  <official_title>A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the addition of daratumumab to velcade&#xD;
      (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared&#xD;
      with VMP alone in participants with previously untreated multiple myeloma who are ineligible&#xD;
      for high dose chemotherapy and autologous stem cell transplant (ASCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of 3 phases: Screening Phase (within 21 days prior to randomization),&#xD;
      Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up&#xD;
      Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal&#xD;
      of consent, or the study ends, whichever occurs first). Treatment phase will include 2&#xD;
      treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone&#xD;
      and Treatment B: participants will receive daratumumab in combination with VMP).Two interim&#xD;
      analyses are planned. The first will be to evaluate safety after a total of approximately 100&#xD;
      participants have been treated for at least 2 cycles or discontinued the study treatment. The&#xD;
      second will be to evaluate cumulative interim safety and efficacy data, and will be performed&#xD;
      when approximately 216 PFS events have been accumulated. The final OS analysis will occur&#xD;
      when approximately 382 deaths have occurred. Efficacy will be primarily measured by&#xD;
      comparison of PFS between the two treatment arms. Participants' safety will be monitored&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 9, 2014</start_date>
  <completion_date type="Anticipated">February 27, 2024</completion_date>
  <primary_completion_date type="Actual">November 21, 2017</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 randomization to either disease progression or death whichever occurs first (up to 2.4 years)</time_frame>
    <description>PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase&gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % &gt;=10%);Bone marrow PC%: absolute% &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
    <description>The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%, in addition to the above criteria, if present at baseline, a &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Very Good Partial Response (VGPR) or Better</measure>
    <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
    <description>VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or &gt;= 90% reduction in serum M-protein plus urine M-protein level less than (&lt;) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and &lt; 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Response (CR) or Better</measure>
    <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
    <description>CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (&lt;) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Negative Minimal Residual Disease (MRD)</measure>
    <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
    <description>The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization to death (up to approximately 2.4 years)</time_frame>
    <description>Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival on Next Line of Therapy (PFS2)</measure>
    <time_frame>From randomization to either disease progression or death whichever occurs first (up to 2.4 years)</time_frame>
    <description>Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Stringent Complete Response (sCR)</measure>
    <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
    <description>sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; &lt;5% plasma cells (PCs) in bone marrow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression (TTP)</measure>
    <time_frame>From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)</time_frame>
    <description>TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % &gt;=10%); Bone marrow PC %: absolute % &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>From randomization to first documented PR or better (up to 2.4 years)</time_frame>
    <description>Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 2.4 years</time_frame>
    <description>DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase&gt;=0.5 g/dL); Urine M-component (absolute increase&gt;=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%&gt;=10%); Bone marrow PC's %: absolute%&gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Treatment (TNT)</measure>
    <time_frame>Approximately up to 2.4 years</time_frame>
    <description>Time to next treatment is defined as the time from randomization to the start of the next-line treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Best M-protein Response</measure>
    <time_frame>Approximately up to 2.4 years</time_frame>
    <description>Percentage of participants with Best M- protein response of 100% reduction and &gt;=90% to &lt; 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score</measure>
    <time_frame>Baseline, Months 3, 6, 9, 12 and 18</time_frame>
    <description>The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)</measure>
    <time_frame>Baseline, Months 3, 6, 9, 12 and 18</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 profile (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>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score</measure>
    <time_frame>Baseline, Months 3, 6, 9, 12 and 18</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 profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">706</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Treatment Arm A (VMP Alone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Velcade</intervention_name>
    <description>Participants will receive velcade 1.3 mg/m^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9.</description>
    <arm_group_label>Treatment Arm A (VMP Alone)</arm_group_label>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>Participants will receive melphalan 9 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
    <arm_group_label>Treatment Arm A (VMP Alone)</arm_group_label>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.</description>
    <arm_group_label>Treatment Arm A (VMP Alone)</arm_group_label>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daratumumab IV</intervention_name>
    <description>Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study .</description>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute.</description>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daratumumab SC</intervention_name>
    <description>Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC.</description>
    <arm_group_label>Treatment Arm B (D-VMP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have documented multiple myeloma satisfying the calcium elevation,&#xD;
             renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria,&#xD;
             monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or&#xD;
             presence of a biopsy proven plasmacytoma, and measurable secretory disease, as&#xD;
             assessed by the central laboratory, and defined in protocol&#xD;
&#xD;
          -  Participants who are newly diagnosed and not considered candidate for high-dose&#xD;
             chemotherapy with stem cell transplantation (SCT) due to: being age &gt;=65 years, or in&#xD;
             participants &lt;65 years: presence of important comorbid conditions likely to have a&#xD;
             negative impact on tolerability of high dose chemotherapy with stem cell&#xD;
             transplantation&#xD;
&#xD;
          -  Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
             score of 0, 1, or 2&#xD;
&#xD;
          -  Meet the clinical laboratory criteria as specified in the protocol&#xD;
&#xD;
          -  A woman of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening within 14 days prior to randomization&#xD;
&#xD;
          -  Women of childbearing potential must commit to either abstain continuously from&#xD;
             heterosexual sexual intercourse or to use 2 methods of reliable birth control&#xD;
             simultaneously. This includes one highly effective form of contraception (tubal&#xD;
             ligation, intrauterine device, hormonal [birth control pills, injections, hormonal&#xD;
             patches, vaginal rings or implants] or partner's vasectomy) and one additional&#xD;
             effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical&#xD;
             cap). Contraception must begin prior to dosing. Reliable contraception is indicated&#xD;
             even where there has been a history of infertility, unless due to hysterectomy or&#xD;
             bilateral oophorectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of&#xD;
             undetermined significance, or smoldering multiple myeloma&#xD;
&#xD;
          -  Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM&#xD;
             M-protein is present in the absence of a clonal plasma cell infiltration with lytic&#xD;
             bone lesions&#xD;
&#xD;
          -  Participant has prior or current systemic therapy or SCT for multiple myeloma, with&#xD;
             the exception of an emergency use of a short course (equivalent of dexamethasone 40&#xD;
             mg/day for 4 days) of corticosteroids before treatment&#xD;
&#xD;
          -  Participant has peripheral neuropathy or neuropathic pain Grade 2 or higher, as&#xD;
             defined by the national cancer institute common terminology criteria for adverse&#xD;
             events (NCI CTCAE) Version 4&#xD;
&#xD;
          -  Participant has a history of malignancy (other than multiple myeloma) within 3 years&#xD;
             before the date of randomization (exceptions are squamous and basal cell carcinomas of&#xD;
             the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the&#xD;
             investigator, with concurrence with the sponsor's medical monitor, is considered cured&#xD;
             with minimal risk of recurrence within 3 years)&#xD;
&#xD;
          -  Participant has had radiation therapy within 14 days of randomization&#xD;
&#xD;
          -  Participant has had plasmapheresis within 28 days of randomization&#xD;
&#xD;
          -  Participant has known chronic obstructive pulmonary disease (COPD) (defined as a&#xD;
             forced expiratory volume in 1 second [FEV1] &lt;50% of predicted normal), known moderate&#xD;
             or severe persistent asthma within the last 2 years or currently has uncontrolled&#xD;
             asthma of any classification (controlled intermittent asthma or controlled mild&#xD;
             persistent asthma is allowed)&#xD;
&#xD;
          -  Participants with known or suspected COPD must have a FEV1 test during screening&#xD;
&#xD;
          -  Participant is known to be seropositive for human immunodeficiency virus (HIV), known&#xD;
             to have hepatitis B surface antigen positivity, or history of to have a history of&#xD;
             hepatitis C&#xD;
&#xD;
          -  Participant has any concurrent medical or psychiatric condition or disease (example&#xD;
             active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary&#xD;
             disease) that is likely to interfere with the study procedures or results, or that in&#xD;
             the opinion of the investigator, would constitute a hazard for participating in this&#xD;
             study&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>California City</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corona</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
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  <location>
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      <address>
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      <address>
        <city>Altindag</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aydin</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Izmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kayseri</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Samsun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tekirdag</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cherkassy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dnepropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkov</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Khmelnitskiy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Colchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Harlow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woolwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>North Macedonia</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>November 21, 2018</results_first_submitted>
  <results_first_submitted_qc>November 21, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2018</results_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Bortezomib</keyword>
  <keyword>Velcade</keyword>
  <keyword>Melphalan</keyword>
  <keyword>Prednisone</keyword>
  <keyword>Daratumumab</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>Prednisone</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Daratumumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <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>February 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02195479/Prot_000.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>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02195479/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Results are reported up to second interim analysis (up to 2.4 years). Complete data through 6.4 years will be reported within 1 year of end of study trial date when final data based on study completion date will be available.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Velcade, Melphalan and Prednisone (VMP)</title>
          <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
        </group>
        <group group_id="P2">
          <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
          <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="356"/>
                <participants group_id="P2" count="350"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="354"/>
                <participants group_id="P2" count="346"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">None of the participants completed the study as the study is still on-going.</participants>
                <participants group_id="P2" count="0">None of the participants completed the study as the study is still on-going.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="356"/>
                <participants group_id="P2" count="350"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="291"/>
                <participants group_id="P2" count="297"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Velcade, Melphalan and Prednisone (VMP)</title>
          <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
        </group>
        <group group_id="B2">
          <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
          <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</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="356"/>
            <count group_id="B2" value="350"/>
            <count group_id="B3" value="706"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.5" spread="5.82"/>
                    <measurement group_id="B2" value="71.3" spread="6.66"/>
                    <measurement group_id="B3" value="71.4" spread="6.25"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="379"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="167"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="332"/>
                    <measurement group_id="B2" value="320"/>
                    <measurement group_id="B3" value="652"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="304"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B3" value="601"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Croatia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Macedonia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Democratic People'S Republic Of</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage of Disease (ISS)</title>
          <description>The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (&lt;)3.5 milligram per liter (mg/L) and albumin greater than or equal to (&gt;=) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin &gt;= 5.5 mg/L.</description>
          <population>Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this study specific characteristic.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="331"/>
                    <count group_id="B2" value="333"/>
                    <count group_id="B3" value="664"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="331"/>
                    <count group_id="B2" value="333"/>
                    <count group_id="B3" value="664"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="247"/>
                    <measurement group_id="B2" value="226"/>
                    <measurement group_id="B3" value="473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="331"/>
                    <count group_id="B2" value="333"/>
                    <count group_id="B3" value="664"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from multiple myeloma (MM) diagnosis</title>
          <description>Time from multiple myeloma (MM) diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.</description>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                    <count group_id="B2" value="350"/>
                    <count group_id="B3" value="706"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.27" spread="1.737"/>
                    <measurement group_id="B2" value="1.09" spread="1.056"/>
                    <measurement group_id="B3" value="1.18" spread="1.442"/>
                  </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- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase&gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % &gt;=10%);Bone marrow PC%: absolute% &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
        <time_frame>From randomization to either disease progression or death whichever occurs first (up to 2.4 years)</time_frame>
        <population>Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase&gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % &gt;=10%);Bone marrow PC%: absolute% &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
          <population>Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.14" lower_limit="16.53" upper_limit="19.91"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% confidence interval (CI) was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%, in addition to the above criteria, if present at baseline, a &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
        <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%, in addition to the above criteria, if present at baseline, a &gt;=50% reduction in the size of soft tissue plasmacytomas is also required.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9"/>
                    <measurement group_id="O2" value="90.9"/>
                  </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</title>
        <description>VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or &gt;= 90% reduction in serum M-protein plus urine M-protein level less than (&lt;) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and &lt; 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.</description>
        <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Very Good Partial Response (VGPR) or Better</title>
          <description>VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or &gt;= 90% reduction in serum M-protein plus urine M-protein level less than (&lt;) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and &lt; 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.7"/>
                    <measurement group_id="O2" value="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Response (CR) or Better</title>
        <description>CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (&lt;) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.</description>
        <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Response (CR) or Better</title>
          <description>CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (&lt;) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.4"/>
                    <measurement group_id="O2" value="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Negative Minimal Residual Disease (MRD)</title>
        <description>The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).</description>
        <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Negative Minimal Residual Disease (MRD)</title>
          <description>The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                    <measurement group_id="O2" value="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.</description>
        <time_frame>From randomization to death (up to approximately 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival on Next Line of Therapy (PFS2)</title>
        <description>Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.</description>
        <time_frame>From randomization to either disease progression or death whichever occurs first (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival on Next Line of Therapy (PFS2)</title>
          <description>Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Stringent Complete Response (sCR)</title>
        <description>sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; &lt;5% plasma cells (PCs) in bone marrow.</description>
        <time_frame>From randomization to disease progression (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Stringent Complete Response (sCR)</title>
          <description>sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; &lt;5% plasma cells (PCs) in bone marrow.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3"/>
                    <measurement group_id="O2" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Disease Progression (TTP)</title>
        <description>TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % &gt;=10%); Bone marrow PC %: absolute % &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
        <time_frame>From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Disease Progression (TTP)</title>
          <description>TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase &gt;=0.5 gram per deciliter [g/dL] and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % &gt;=10%); Bone marrow PC %: absolute % &gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.35" lower_limit="17.38" upper_limit="22.67"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response</title>
        <description>Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%.</description>
        <time_frame>From randomization to first documented PR or better (up to 2.4 years)</time_frame>
        <population>Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. &quot;N&quot; (number of participants analyzed) signifies number of participants evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response</title>
          <description>Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: &gt;=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to &lt;200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, &gt;=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was &gt;=30%.</description>
          <population>Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. &quot;N&quot; (number of participants analyzed) signifies number of participants evaluable for this endpoint.</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="263"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" lower_limit="0.7" upper_limit="12.6"/>
                    <measurement group_id="O2" value="0.79" lower_limit="0.4" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase&gt;=0.5 g/dL); Urine M-component (absolute increase&gt;=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%&gt;=10%); Bone marrow PC's %: absolute%&gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
        <time_frame>Up to 2.4 years</time_frame>
        <population>Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. &quot;N&quot;(number of participants analyzed) signifies number of participants evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase&gt;=0.5 g/dL); Urine M-component (absolute increase&gt;=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase &gt;10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%&gt;=10%); Bone marrow PC's %: absolute%&gt;10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
          <population>Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. &quot;N&quot;(number of participants analyzed) signifies number of participants evaluable for this endpoint.</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="263"/>
                <count group_id="O2" value="318"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" lower_limit="18.4" upper_limit="NA">Upper limit of 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Treatment (TNT)</title>
        <description>Time to next treatment is defined as the time from randomization to the start of the next-line treatment.</description>
        <time_frame>Approximately up to 2.4 years</time_frame>
        <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Treatment (TNT)</title>
          <description>Time to next treatment is defined as the time from randomization to the start of the next-line treatment.</description>
          <population>ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.</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="356"/>
                <count group_id="O2" value="350"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="21.4" upper_limit="NA">Median and upper limit of 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median and 95% CI was not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Best M-protein Response</title>
        <description>Percentage of participants with Best M- protein response of 100% reduction and &gt;=90% to &lt; 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).</description>
        <time_frame>Approximately up to 2.4 years</time_frame>
        <population>Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. 'n' (number of participants analyzed) signifies number of participants analyzed for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Best M-protein Response</title>
          <description>Percentage of participants with Best M- protein response of 100% reduction and &gt;=90% to &lt; 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).</description>
          <population>Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. 'n' (number of participants analyzed) signifies number of participants analyzed for each specified category.</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="341"/>
                <count group_id="O2" value="337"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Best M-protein response in serum: 100% reduction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7"/>
                    <measurement group_id="O2" value="58.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best M-protein response in serum:&gt;= 90 to &lt; 100%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6"/>
                    <measurement group_id="O2" value="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best M-protein response in urine:100% reduction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.4"/>
                    <measurement group_id="O2" value="90.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best M-protein response in urine:&gt;=90 to &lt; 100%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best response in dFLC:100% reduction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best response in dFLC: &gt;=90% to &lt; 100% reduction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score</title>
        <description>The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.</description>
        <time_frame>Baseline, Months 3, 6, 9, 12 and 18</time_frame>
        <population>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score</title>
          <description>The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from &quot;1-not at all&quot; to &quot;4-very much&quot; to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.</description>
          <population>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="327"/>
                <count group_id="O2" value="316"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="7.1" upper_limit="11.7"/>
                    <measurement group_id="O2" value="8.8" lower_limit="6.6" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="8.1" upper_limit="12.9"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.3" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="9.4" upper_limit="14.4"/>
                    <measurement group_id="O2" value="11.1" lower_limit="8.8" upper_limit="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                    <count group_id="O2" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="8.4" upper_limit="13.6"/>
                    <measurement group_id="O2" value="12.6" lower_limit="10.2" upper_limit="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="8.5" upper_limit="16.9"/>
                    <measurement group_id="O2" value="11.4" lower_limit="7.9" upper_limit="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue 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 profile (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, Months 3, 6, 9, 12 and 18</time_frame>
        <population>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue 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 profile (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>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
          <units>Units 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="325"/>
                <count group_id="O2" value="315"/>
              </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="325"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.33" spread="20.610"/>
                    <measurement group_id="O2" value="57.90" spread="20.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="241"/>
                    <count group_id="O2" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="18.417"/>
                    <measurement group_id="O2" value="9.28" spread="20.195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="209"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.40" spread="18.002"/>
                    <measurement group_id="O2" value="10.83" spread="20.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="225"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.89" spread="19.516"/>
                    <measurement group_id="O2" value="12.50" spread="20.616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                    <count group_id="O2" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.80" spread="19.386"/>
                    <measurement group_id="O2" value="10.79" spread="20.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.65" spread="19.284"/>
                    <measurement group_id="O2" value="12.04" spread="20.126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score</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 profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.</description>
        <time_frame>Baseline, Months 3, 6, 9, 12 and 18</time_frame>
        <population>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Velcade, Melphalan and Prednisone (VMP)</title>
            <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
            <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score</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 profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.</description>
          <population>ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.</population>
          <units>Units 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="325"/>
                <count group_id="O2" value="315"/>
              </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="325"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.301"/>
                    <measurement group_id="O2" value="0.57" spread="0.292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="241"/>
                    <count group_id="O2" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.312"/>
                    <measurement group_id="O2" value="0.12" spread="0.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="209"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.270"/>
                    <measurement group_id="O2" value="0.13" spread="0.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="225"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.270"/>
                    <measurement group_id="O2" value="0.16" spread="0.270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                    <count group_id="O2" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.278"/>
                    <measurement group_id="O2" value="0.17" spread="0.287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.247"/>
                    <measurement group_id="O2" value="0.13" spread="0.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 2.4 years</time_frame>
      <desc>Safety population defined as participants who have received at least 1 administration of any study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Velcade, Melphalan and Prednisone (VMP)</title>
          <description>Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.</description>
        </group>
        <group group_id="E2">
          <title>Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)</title>
          <description>Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="48" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="115" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="144" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardio-Respiratory Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cardiovascular Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Stress Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Retinal Detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Adhesions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Anal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Diverticular Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Gastric Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Ileus Paralytic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Large Intestine Perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Oesophageal Rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Oesophagitis Haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Generalised Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Candida Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Clostridium Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Enterococcal Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Epiglottitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>H1n1 Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Herpes Zoster Disseminated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Infective Exacerbation of Chronic Obstructive Airways Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Infective Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Meningitis Pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neutropenic Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pelvic Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia Pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia Streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia Viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pseudomembranous Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pulmonary Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Respiratory Syncytial Virus Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Tuberculous Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chest Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Skeletal Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Subarachnoid Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Toxicity to Various Agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Traumatic Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>C-Reactive Protein Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Oxygen Saturation Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Tumour Lysis Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dactylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Spinal Column Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute Myeloid Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of Colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bile Duct Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Oesophageal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Plasmacytoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Rectal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Renal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic Nervous System Imbalance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cerebral Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neurotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Parkinson's Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Peripheral Motor Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Peripheral Sensorimotor Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Spinal Cord Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </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" subjects_affected="5" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Prerenal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Interstitial Lung Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Laryngeal Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Obstructive Airways Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumothorax Spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </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" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Erythema Multiforme</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Rash Vesicular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypovolaemic Shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 20.0</default_vocab>
        <default_assessment>Non-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="331" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="324" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="131" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="186" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="171" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="189" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="168" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="78" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="121" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="98" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="346"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="346"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="354"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="346"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Executive Medical Director</name_or_title>
      <organization>Janssen Research and Development, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT02195479
org study id: CR104761
secondary id: 54767414MMY3007
secondary id: 2014-002272-88
nct id: NCT02195479
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if the addition of daratumumab to velcade
      (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared
      with VMP alone in participants with previously untreated multiple myeloma who are ineligible
      for high dose chemotherapy and autologous stem cell transplant (ASCT).
The study consists of 3 phases: Screening Phase (within 21 days prior to randomization),
      Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up
      Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal
      of consent, or the study ends, whichever occurs first). Treatment phase will include 2
      treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone
      and Treatment B: participants will receive daratumumab in combination with VMP).Two interim
      analyses are planned. The first will be to evaluate safety after a total of approximately 100
      participants have been treated for at least 2 cycles or discontinued the study treatment. The
      second will be to evaluate cumulative interim safety and efficacy data, and will be performed
      when approximately 216 PFS events have been accumulated. The final OS analysis will occur
      when approximately 382 deaths have occurred. Efficacy will be primarily measured by
      comparison of PFS between the two treatment arms. Participants' safety will be monitored
      throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
description: PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % >=10%);Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
measure: Overall Response Rate (ORR)
time frame: From randomization to disease progression (up to 2.4 years)
description: The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better
time frame: From randomization to disease progression (up to 2.4 years)
description: VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
measure: Percentage of Participants With Complete Response (CR) or Better
time frame: From randomization to disease progression (up to 2.4 years)
description: CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
measure: Percentage of Participants With Negative Minimal Residual Disease (MRD)
time frame: From randomization to disease progression (up to 2.4 years)
description: The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).
measure: Overall Survival (OS)
time frame: From randomization to death (up to approximately 2.4 years)
description: Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
measure: Progression Free Survival on Next Line of Therapy (PFS2)
time frame: From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
description: Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.
measure: Percentage of Participants With Stringent Complete Response (sCR)
time frame: From randomization to disease progression (up to 2.4 years)
description: sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow.
measure: Time to Disease Progression (TTP)
time frame: From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)
description: TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
measure: Time to Response
time frame: From randomization to first documented PR or better (up to 2.4 years)
description: Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%.
measure: Duration of Response (DOR)
time frame: Up to 2.4 years
description: DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
measure: Time to Next Treatment (TNT)
time frame: Approximately up to 2.4 years
description: Time to next treatment is defined as the time from randomization to the start of the next-line treatment.
measure: Percentage of Participants With Best M-protein Response
time frame: Approximately up to 2.4 years
description: Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
time frame: Baseline, Months 3, 6, 9, 12 and 18
description: The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.
measure: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
time frame: Baseline, Months 3, 6, 9, 12 and 18
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 profile (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.
measure: Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
time frame: Baseline, Months 3, 6, 9, 12 and 18
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 profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.
arm group label: Treatment Arm A (VMP Alone)
arm group type: Active Comparator
description: Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.
arm group label: Treatment Arm B (D-VMP)
arm group type: Experimental
description: Participants will receive velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
intervention type: Drug
intervention name: Velcade
description: Participants will receive velcade 1.3 mg/m^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9.
arm group label: Treatment Arm A (VMP Alone)
arm group label: Treatment Arm B (D-VMP)
intervention type: Drug
intervention name: Melphalan
description: Participants will receive melphalan 9 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.
arm group label: Treatment Arm A (VMP Alone)
arm group label: Treatment Arm B (D-VMP)
intervention type: Drug
intervention name: Prednisone
description: Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9.
arm group label: Treatment Arm A (VMP Alone)
arm group label: Treatment Arm B (D-VMP)
intervention type: Drug
intervention name: Daratumumab IV
description: Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study .
arm group label: Treatment Arm B (D-VMP)
intervention type: Drug
intervention name: Dexamethasone
description: Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute.
arm group label: Treatment Arm B (D-VMP)
intervention type: Drug
intervention name: Daratumumab SC
description: Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC.
arm group label: Treatment Arm B (D-VMP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Bulgaria
country: Croatia
country: Czechia
country: Georgia
country: Germany
country: Greece
country: Hungary
country: Japan
country: Korea, Republic of
country: North Macedonia
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Serbia
country: Spain
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
country: Macedonia, The Former Yugoslav Republic of
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Prednisone
mesh term: Melphalan
mesh term: Bortezomib
mesh term: Daratumumab
mesh term: Antibodies, Monoclonal
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