<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/NCT03277105</url>
  </required_header>
  <id_info>
    <org_study_id>CR108342</org_study_id>
    <secondary_id>2017-000206-38</secondary_id>
    <secondary_id>54767414MMY3012</secondary_id>
    <nct_id>NCT03277105</nct_id>
  </id_info>
  <brief_title>A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma</brief_title>
  <official_title>A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to show that subcutaneous (SC) administration of daratumumab&#xD;
      co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to&#xD;
      intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response&#xD;
      rate (ORR) and maximum trough concentration (Ctrough).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population will consist of adults diagnosed with multiple myeloma who have received&#xD;
      at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an&#xD;
      immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The&#xD;
      study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a&#xD;
      follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be&#xD;
      assessed at scheduled time. Follow-up will continue until the end of the data collection&#xD;
      period, approximately 24 months after the last participant was randomized or when the median&#xD;
      overall survival for both arms has been reached, whichever occurs first. The primary&#xD;
      hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not&#xD;
      inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg)&#xD;
      in participants with multiple myeloma who have received at least 3 prior lines of therapy&#xD;
      including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease&#xD;
      is refractory to both a PI and an IMiD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Anticipated">December 26, 2023</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</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>Overall Response Rate (ORR)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to less than (&lt;) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) was 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 was also required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Trough Concentration (Ctrough) of Daratumumab</measure>
    <time_frame>Predose on Cycle 3 Day 1 (each cycle of 28 days)</time_frame>
    <description>Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Percentage of participants with treatment-emergent infusion-related reactions were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be &gt;=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be &gt;=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be &gt;10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be &gt;=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Very Good Partial Response (VGPR) or Better</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or &gt;=90 percent (%) reduction in serum M-protein plus urine M-protein &lt;100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and &lt;5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Response (Including sCR) or Better</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and &lt;5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Therapy</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)</measure>
    <time_frame>Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)</time_frame>
    <description>Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be &gt;= 0.5 g/dL and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be &gt; 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; 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 Partial Response (PR) or Better</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Time to PR or better was defined as the time from randomization until onset of first response of PR or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Very Good Partial Response (VGPR) or Better</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Response (CR) or Better</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Time to CR or better was defined as the time from randomization until onset of first CR or better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">522</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Dara SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dara IV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg 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>Dara SC</intervention_name>
    <description>Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.</description>
    <arm_group_label>Dara IV</arm_group_label>
    <arm_group_label>Dara SC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dara IV</intervention_name>
    <description>Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.</description>
    <arm_group_label>Dara IV</arm_group_label>
    <other_name>JNJ-54767414</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of a response (Partial response [PR] or better based on investigator's&#xD;
             determination of response by international myeloma working group [IMWG] criteria) to&#xD;
             at least 1 prior treatment regimen&#xD;
&#xD;
          -  Received at least 3 prior lines of therapy including a proteasome inhibitor (PI)&#xD;
             (greater than or equal to [&gt;=] 2 cycles or 2 months of treatment) and an&#xD;
             immunomodulatory drug (IMiD) (&gt;=2 cycles or 2 months of treatment) in any order during&#xD;
             the course of treatment (except for participants who discontinued either of these&#xD;
             treatments due to a severe allergic reaction within the first 2 cycles/months). A&#xD;
             single line of therapy may consist of 1 or more agents, and may include induction,&#xD;
             hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy,&#xD;
             bisphosphonate, or a single short course of corticosteroids (no more than the&#xD;
             equivalent of dexamethasone 40 milligram/day [mg/day] for 4 days) would not be&#xD;
             considered prior lines of therapy&#xD;
&#xD;
          -  Documented multiple myeloma as defined by the criteria below:&#xD;
&#xD;
               1. Multiple myeloma diagnosis according to the IMWG diagnostic criteria&#xD;
&#xD;
               2. Measurable disease at Screening as defined by any of the following:&#xD;
&#xD;
                    1. Serum M-protein level &gt;=1.0 gram per deciliter (g/dL) or urine M-protein&#xD;
                       level &gt;=200 mg/24 hours; or&#xD;
&#xD;
                    2. Light chain multiple myeloma without measurable disease in the serum or the&#xD;
                       urine: Serum immunoglobulin free light chain (FLC) &gt;=10 mg/dL and abnormal&#xD;
                       serum immunoglobulin kappa lambda FLC ratio&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2&#xD;
&#xD;
          -  Meet the clinical laboratory criteria as specified in the protocol&#xD;
&#xD;
          -  Women of childbearing potential must have a negative urine or serum pregnancy test at&#xD;
             screening within 14 days prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received daratumumab or other anti-CD38 therapies previously&#xD;
&#xD;
          -  Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the&#xD;
             treatment, whichever is longer, before the date of randomization. The only exception&#xD;
             is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40&#xD;
             mg/day for a maximum of 4 days) before treatment&#xD;
&#xD;
          -  Received autologous stem cell transplant within 12 weeks before the date of&#xD;
             randomization, or the participant has previously received allogeneic stem cell&#xD;
             transplant (regardless of timing)&#xD;
&#xD;
          -  Plans to undergo a stem cell transplant prior to progression of disease on this study&#xD;
             (these participants should not be enrolled to reduce disease burden prior to&#xD;
             transplant)&#xD;
&#xD;
          -  History of malignancy (other than multiple myeloma) unless all treatment of that&#xD;
             malignancy was completed at least 2 years before consent and the patient has no&#xD;
             evidence of disease. Further exceptions are squamous and basal cell carcinomas of the&#xD;
             skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion,&#xD;
             that in the opinion of the investigator, with concurrence with the sponsor's medical&#xD;
             monitor, is considered cured with minimal risk of recurrence within 3 years&#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>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215-5418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle Hospital</name>
      <address>
        <city>Waratah</city>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital</name>
      <address>
        <city>Woodville South</city>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Pio XII</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN</name>
      <address>
        <city>Florianopolis</city>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Doutor Amaral Carvalho</name>
      <address>
        <city>Jau</city>
        <zip>17210-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia</name>
      <address>
        <city>Joinville</city>
        <zip>89201-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo</name>
      <address>
        <city>Passo Fundo</city>
        <zip>99010-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Educacao, Pesquisa e Gestao em Saude</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22775-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEHON</name>
      <address>
        <city>Salvador</city>
        <zip>45995-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Sao Germano</name>
      <address>
        <city>São Paulo</city>
        <zip>01455-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Das Clinicas Da Faculdade De Medicina Da USP</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Gordon &amp; Leslie Diamond Health Care Center</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Québec -L'Hôtel-Dieu de Québec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni</name>
      <address>
        <city>Plzen</city>
        <zip>323 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Kralovske Vinohrady</name>
      <address>
        <city>Praha 10</city>
        <zip>100 34</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie</name>
      <address>
        <city>Praha 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen - Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes hôtel-Dieu</name>
      <address>
        <city>Nantes Cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Boreaux</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers - Hôpital la Milétrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy Brabois</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra General Hospital of Athens</name>
      <address>
        <city>Athens Attica</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center - Oncology</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Med.Center - Hematology Institute</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center, Beilinson Campus</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center Tel Hashomer</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Sant'Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Villa Sofia-Cervello</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda USL di Piacenza</name>
      <address>
        <city>Piacenza</city>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università di Roma La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chugoku Central Hospital</name>
      <address>
        <city>Fukuyama</city>
        <zip>720-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital</name>
      <address>
        <city>Gifu</city>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Gunma</city>
        <zip>371-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Hyogo</city>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Iwate</city>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Perfectural University of Medicine</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuyama Red Cross Hospital</name>
      <address>
        <city>Matsuyama</city>
        <zip>790-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Okayama Medical Center</name>
      <address>
        <city>Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Sendai Medical Center</name>
      <address>
        <city>Sendai-City</city>
        <zip>983-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shibukawa Medical Center</name>
      <address>
        <city>Shibukawa</city>
        <zip>377-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Medical Center</name>
      <address>
        <city>Shibuya</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-Si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza</name>
      <address>
        <city>Brzozow</city>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich</name>
      <address>
        <city>Chorzów</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie Sp. z o.o.</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny w Legnicy</name>
      <address>
        <city>Legnica</city>
        <zip>59-220</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego</name>
      <address>
        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Hospital of Dzerzhinsk</name>
      <address>
        <city>Dzerzhinsk</city>
        <zip>606019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ekaterinburg City Clinical Hospital # 7</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620137</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.P. Botkin Moscow City Clinical Hospital</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital # 40</name>
      <address>
        <city>Moscow</city>
        <zip>129301</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nizhniy Novgorod Region Clinical Hospital</name>
      <address>
        <city>Nizny Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penza Regional Oncology Dispensary</name>
      <address>
        <city>Penza</city>
        <zip>440071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ryazan Regional Clinical Hospital</name>
      <address>
        <city>Ryazan</city>
        <zip>390039</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg City Hospital #15</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara Region Clinical Hospital</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute of Hematology and Transfusiology</name>
      <address>
        <city>St-Petersburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Dispensary of Komi Republic</name>
      <address>
        <city>Syktyvkar</city>
        <zip>167904</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Germans Trias I Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinic I Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Virgen de Las Nieves</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. de Canarias</name>
      <address>
        <city>La Laguna</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. de Leon</name>
      <address>
        <city>Leon</city>
        <zip>24008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Gral. Univ. Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Univ. de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Quiron Madrid Pozuelo</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Falu Lasarett</name>
      <address>
        <city>Falun</city>
        <zip>79182</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingborgs lasarett</name>
      <address>
        <city>Helsingborg</city>
        <zip>25187</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital, Huddinge</name>
      <address>
        <city>Huddinge</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skanes universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <zip>222 41</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norrlands University Hospital</name>
      <address>
        <city>Umea</city>
        <zip>907 46</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang-Hua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>50006</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung,</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center</name>
      <address>
        <city>Dnepropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Clinical Hospital</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute, Dept. of chemotherapy of hemoblastosis</name>
      <address>
        <city>Kiev</city>
        <zip>03022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department</name>
      <address>
        <city>Kiev</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'</name>
      <address>
        <city>Kiev</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine</name>
      <address>
        <city>Lviv</city>
        <zip>79044</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mykolaiv Regional Clinical Hospital</name>
      <address>
        <city>Mykolaiv</city>
        <zip>54000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital</name>
      <address>
        <city>Poltava</city>
        <zip>36011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackpool Victoria Hospital</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary - Haematology</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Bartholomew's Hospital</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital NHS Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 9BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Surrey</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>June 19, 2020</results_first_submitted>
  <results_first_submitted_qc>July 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2020</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>
  <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>
  <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>January 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03277105/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>February 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03277105/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Daratumumab IV</title>
          <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
        </group>
        <group group_id="P2">
          <title>Daratumumab SC</title>
          <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="259"/>
                <participants group_id="P2" count="263"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="258"/>
                <participants group_id="P2" count="260"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="259"/>
                <participants group_id="P2" count="263"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="171"/>
                <participants group_id="P2" count="175"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Daratumumab IV</title>
          <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
        </group>
        <group group_id="B2">
          <title>Daratumumab SC</title>
          <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</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="259"/>
            <count group_id="B2" value="263"/>
            <count group_id="B3" value="522"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.8" spread="10.16"/>
                    <measurement group_id="B2" value="65.3" spread="9.11"/>
                    <measurement group_id="B3" value="66.1" spread="9.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="237"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="285"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="227"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="452"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                    <measurement group_id="B2" value="207"/>
                    <measurement group_id="B3" value="408"/>
                  </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="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </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>AUSTRALIA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BRAZIL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CANADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CZECH REPUBLIC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FRANCE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GREECE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ISRAEL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ITALY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>JAPAN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POLAND</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RUSSIAN FEDERATION</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SOUTH KOREA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SPAIN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SWEDEN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAIWAN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UKRAINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED KINGDOM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UNITED STATES</title>
              <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_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 milligrams per liter (mg/L) and albumin greater than or equal to (&gt;=) 3.5 grams (g) per 100 milliliter; Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin &gt;= 5.5 mg/L.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stage I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Data missing or Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to less than (&lt;) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) was 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 was also required.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (&gt;=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by &gt;=90% or to less than (&lt;) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of &gt;=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, &gt;=50% reduction in bone marrow plasma cells (PCs) was 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 was also required.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.4" lower_limit="33.4" upper_limit="45.6"/>
                    <measurement group_id="O2" value="43.3" lower_limit="37.3" upper_limit="49.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Trough Concentration (Ctrough) of Daratumumab</title>
        <description>Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.</description>
        <time_frame>Predose on Cycle 3 Day 1 (each cycle of 28 days)</time_frame>
        <population>Pharmacokinetics (PK) population included participants who received at least 1 administration of study drug and had at least 1 pharmacokinetics sample concentration value after the first dose administration. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Trough Concentration (Ctrough) of Daratumumab</title>
          <description>Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.</description>
          <population>Pharmacokinetics (PK) population included participants who received at least 1 administration of study drug and had at least 1 pharmacokinetics sample concentration value after the first dose administration. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.</population>
          <units>micrograms per milliliter (mcg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="157"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="525" spread="227"/>
                    <measurement group_id="O2" value="611" spread="318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)</title>
        <description>Percentage of participants with treatment-emergent infusion-related reactions were reported.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)</title>
          <description>Percentage of participants with treatment-emergent infusion-related reactions were reported.</description>
          <population>Safety population included all randomized participants who received at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="260"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5" lower_limit="28.7" upper_limit="40.6"/>
                    <measurement group_id="O2" value="12.7" lower_limit="8.9" upper_limit="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be &gt;=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be &gt;=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be &gt;10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be &gt;=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be &gt;=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be &gt;=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be &gt;10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be &gt;=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" lower_limit="4.73" upper_limit="7.43"/>
                    <measurement group_id="O2" value="5.62" lower_limit="4.70" upper_limit="7.49"/>
                  </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 was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or &gt;=90 percent (%) reduction in serum M-protein plus urine M-protein &lt;100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and &lt;5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Very Good Partial Response (VGPR) or Better</title>
          <description>VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or &gt;=90 percent (%) reduction in serum M-protein plus urine M-protein &lt;100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and &lt;5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" lower_limit="16.1" upper_limit="26.3"/>
                    <measurement group_id="O2" value="21.7" lower_limit="16.8" upper_limit="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Response (Including sCR) or Better</title>
        <description>CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and &lt;5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Response (Including sCR) or Better</title>
          <description>CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and &lt;5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="2.4" upper_limit="8.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.3" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Therapy</title>
        <description>Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Therapy</title>
          <description>Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.30" lower_limit="8.08" upper_limit="10.61"/>
                    <measurement group_id="O2" value="8.80" lower_limit="7.59" upper_limit="11.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="17.02" upper_limit="NA">Median and upper limit of 95% CI were 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 were not estimable due to insufficient number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)</title>
        <description>Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.</description>
        <time_frame>Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)</time_frame>
        <population>Intent-to-treat (ITT) population included all the randomized participants. Here, 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)</title>
          <description>Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.</description>
          <population>Intent-to-treat (ITT) population included all the randomized participants. Here, 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point.</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="259"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="230"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5" spread="15.98"/>
                    <measurement group_id="O2" value="76.9" spread="14.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.1" spread="16.72"/>
                    <measurement group_id="O2" value="78.8" spread="14.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="239"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="16.20"/>
                    <measurement group_id="O2" value="78.7" spread="15.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.2" spread="16.44"/>
                    <measurement group_id="O2" value="79.7" spread="16.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" spread="15.57"/>
                    <measurement group_id="O2" value="80.1" spread="17.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                    <count group_id="O2" value="224"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" spread="16.94"/>
                    <measurement group_id="O2" value="80.0" spread="17.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.2" spread="16.47"/>
                    <measurement group_id="O2" value="79.3" spread="18.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="224"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0" spread="17.39"/>
                    <measurement group_id="O2" value="80.4" spread="17.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                    <count group_id="O2" value="209"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6" spread="17.22"/>
                    <measurement group_id="O2" value="79.5" spread="19.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="17.11"/>
                    <measurement group_id="O2" value="79.6" spread="18.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" spread="17.79"/>
                    <measurement group_id="O2" value="81.9" spread="18.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6" spread="16.01"/>
                    <measurement group_id="O2" value="85.0" spread="16.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" spread="15.54"/>
                    <measurement group_id="O2" value="85.0" spread="15.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 9 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" spread="15.27"/>
                    <measurement group_id="O2" value="85.2" spread="15.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" spread="14.73"/>
                    <measurement group_id="O2" value="85.8" spread="13.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" spread="15.55"/>
                    <measurement group_id="O2" value="84.8" spread="13.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.3" spread="15.88"/>
                    <measurement group_id="O2" value="85.4" spread="14.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 13 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.6" spread="16.57"/>
                    <measurement group_id="O2" value="84.4" spread="15.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="14.62"/>
                    <measurement group_id="O2" value="83.5" spread="15.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 15 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.2" spread="15.22"/>
                    <measurement group_id="O2" value="86.2" spread="13.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" spread="14.84"/>
                    <measurement group_id="O2" value="88.5" spread="13.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 17 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.0" spread="14.34"/>
                    <measurement group_id="O2" value="90.9" spread="11.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" spread="14.13"/>
                    <measurement group_id="O2" value="91.4" spread="11.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 19 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" spread="10.10"/>
                    <measurement group_id="O2" value="89.3" spread="13.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="86.6" spread="18.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 21 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="84.5" spread="20.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="96.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response</title>
        <description>Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be &gt;= 0.5 g/dL and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be &gt; 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; 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 years</time_frame>
        <population>Participants analyzed included responders (PR or better) in ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be &gt;= 0.5 g/dL and &gt;=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be &gt; 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium &gt;11.5 mg/dL) that can be attributed solely to PC proliferative disorder.</description>
          <population>Participants analyzed included responders (PR or better) in ITT analysis set.</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="102"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.64" lower_limit="9.26" upper_limit="NA">Here NA signifies that upper limit of 95% CI was not estimable due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="11.17" lower_limit="9.23" upper_limit="NA">Here NA signifies that upper limit of 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 Partial Response (PR) or Better</title>
        <description>Time to PR or better was defined as the time from randomization until onset of first response of PR or better.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Participants analyzed included responders (PR or better) in ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Partial Response (PR) or Better</title>
          <description>Time to PR or better was defined as the time from randomization until onset of first response of PR or better.</description>
          <population>Participants analyzed included responders (PR or better) in ITT analysis set.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="0.9" upper_limit="6.5"/>
                    <measurement group_id="O2" value="1.02" lower_limit="0.9" upper_limit="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Very Good Partial Response (VGPR) or Better</title>
        <description>Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Participants analyzed included responders (VGPR or better) in ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Very Good Partial Response (VGPR) or Better</title>
          <description>Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.</description>
          <population>Participants analyzed included responders (VGPR or better) in ITT analysis set.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" lower_limit="0.9" upper_limit="10.4"/>
                    <measurement group_id="O2" value="1.94" lower_limit="1.0" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Response (CR) or Better</title>
        <description>Time to CR or better was defined as the time from randomization until onset of first CR or better.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Participants analyzed included responders (CR or better) in ITT analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Daratumumab IV</title>
            <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Daratumumab SC</title>
            <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Response (CR) or Better</title>
          <description>Time to CR or better was defined as the time from randomization until onset of first CR or better.</description>
          <population>Participants analyzed included responders (CR or better) in ITT analysis set.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.42" lower_limit="1.1" upper_limit="14.9"/>
                    <measurement group_id="O2" value="7.39" lower_limit="1.2" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 2 years</time_frame>
      <desc>Safety population included all randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Daratumumab IV</title>
          <description>Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
        </group>
        <group group_id="E2">
          <title>Daratumumab SC</title>
          <description>Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.1</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="77" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="260"/>
              </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="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Disseminated Intravascular Coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hyperviscosity Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="260"/>
              </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="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Gingival Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Oesophageal Varices Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Performance Status Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Campylobacter Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hepatitis B Reactivation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Listeriosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Meningitis Cryptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Meningitis Pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Neutropenic Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jirovecii Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Staphylococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>General Physical Condition Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Oxygen Saturation Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </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="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Spinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of Colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Intestinal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Plasmacytoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Prostate Cancer Recurrent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Tumour Associated Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Monoparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Spinal Cord Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </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="4" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Myeloma Cast Nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pulmonary Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory Collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 21.1</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="204" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="208" subjects_at_risk="260"/>
              </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="58" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="260"/>
              </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="15" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="260"/>
              </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="33" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="260"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="260"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="258"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="260"/>
              </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>If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Head</name_or_title>
      <organization>Janssen Research &amp; 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/NCT03277105
org study id: CR108342
secondary id: 2017-000206-38
secondary id: 54767414MMY3012
nct id: NCT03277105
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab
      co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to
      intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response
      rate (ORR) and maximum trough concentration (Ctrough).
The study population will consist of adults diagnosed with multiple myeloma who have received
      at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an
      immunomodulatory drug (IMiD), or whose disease is refractory to both a PI and an IMiD. The
      study consists of 3 phases: a screening phase (up to 28 days), a treatment phase, and a
      follow-up phase. Efficacy, pharmacokinetics, immunogenicity, biomarkers and safety will be
      assessed at scheduled time. Follow-up will continue until the end of the data collection
      period, approximately 24 months after the last participant was randomized or when the median
      overall survival for both arms has been reached, whichever occurs first. The primary
      hypotheses is that the ORR and maximum Ctrough for Dara SC 1800 milligram (mg) are not
      inferior to the ORR and maximum Ctrough, respectively, for Dara IV 16 mg per kilogram (mg/kg)
      in participants with multiple myeloma who have received at least 3 prior lines of therapy
      including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease
      is refractory to both a PI and an IMiD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: Up to 2 years
description: ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligram (mg)/24 hours, If the serum and urine M-proteins are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels were required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was 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 was also required.
measure: Maximum Trough Concentration (Ctrough) of Daratumumab
time frame: Predose on Cycle 3 Day 1 (each cycle of 28 days)
description: Maximum Ctrough was defined as the serum predose concentration of daratumumab on Cycle 3 Day 1.
measure: Percentage of Participants With Treatment-emergent Infusion-related Reactions (IRR)
time frame: Up to 2 years
description: Percentage of participants with treatment-emergent infusion-related reactions were reported.
measure: Progression Free Survival (PFS)
time frame: Up to 2 years
description: PFS was defined as time from date of randomization to either progression of disease (PD), death due to any cause, whichever occurs first. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M component (absolute increase must be >=0.5 grams per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine Mprotein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better
time frame: Up to 2 years
description: VGPR or better was defined as the percentage of participants who achieved VGPR or better (VGPR, complete response (CR) or stringent complete response [sCR]), based on computerized algorithm as per IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligrams (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cellS (PCs) in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescencea or 2- to 4 color flow cytometry.
measure: Percentage of Participants With Complete Response (Including sCR) or Better
time frame: Up to 2 years
description: CR or better was defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. IMWG criteria for CR- negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by IHC, immunofluorescencea or 2- to 4 color flow cytometry.
measure: Time to Next Therapy
time frame: Up to 2 years
description: Time to next therapy was defined as the time from randomization to the start of the first subsequent anti-cancer therapy.
measure: Overall Survival (OS)
time frame: Up to 2 years
description: OS was defined as the time from the date of randomization to the date of the participant's death due to any cause.
measure: Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
time frame: Cycle 1 (Days 8,15 and 22), Cycle 2 (Days 1,8,15 and 22), Cycle 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21 and 22 (Day 1)
description: Modified-CTSQ contain 9 items (2 items for Thoughts about Cancer Therapy and 7 items in a defined domain of Satisfaction with Therapy) specific to satisfaction with therapy and for comparison of SC and IV administration. Satisfaction with therapy was calculated based on 7-items using 5-point verbal rating scale, where 1= never and 5= always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health. At least 5 of the 7 items within the Satisfaction with Therapy domain had to be completed to calculate a domain score. No domain score was calculated for Thoughts about Cancer Therapy.
measure: Duration of Response
time frame: Up to 2 years
description: Duration of response was defined as the duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG criteria. PD was defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
measure: Time to Partial Response (PR) or Better
time frame: Up to 2 years
description: Time to PR or better was defined as the time from randomization until onset of first response of PR or better.
measure: Time to Very Good Partial Response (VGPR) or Better
time frame: Up to 2 years
description: Time to VGPR or better was defined as the time from randomization until onset of first VGPR or better.
measure: Time to Complete Response (CR) or Better
time frame: Up to 2 years
description: Time to CR or better was defined as the time from randomization until onset of first CR or better.
arm group label: Dara SC
arm group type: Experimental
description: Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
arm group label: Dara IV
arm group type: Active Comparator
description: Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
intervention type: Drug
intervention name: Dara SC
description: Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
arm group label: Dara IV
arm group label: Dara SC
intervention type: Drug
intervention name: Dara IV
description: Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
arm group label: Dara IV
other name: JNJ-54767414
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: Australia
country: Brazil
country: Canada
country: Czechia
country: France
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Taiwan
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
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