<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/NCT02976493</url>
  </required_header>
  <id_info>
    <org_study_id>CA204-179</org_study_id>
    <nct_id>NCT02976493</nct_id>
  </id_info>
  <brief_title>Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma</brief_title>
  <official_title>Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of&#xD;
      elotuzumab in clinical practice in Japan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 18, 2018</completion_date>
  <primary_completion_date type="Actual">June 18, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan</measure>
    <time_frame>Up to 72 weeks</time_frame>
    <description>immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria</measure>
    <time_frame>Up to 72 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>MM patients receiving elotuzumab</arm_group_label>
    <description>Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>MM patients receiving elotuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with relapsed or refractory multiple myeloma who are beginning to receive&#xD;
        elotuzumab at healthcare facilities in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with relapsed or refractory multiple myeloma who are beginning to receive&#xD;
             elotuzumab at the selected sites will be included in this surveillance study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not Applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-0822</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02976493
org study id: CA204-179
nct id: NCT02976493
lead sponsor: 
has dmc: No
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of
      elotuzumab in clinical practice in Japan.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan
time frame: Up to 72 weeks
measure: Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan
time frame: Up to 72 weeks
description: immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.
measure: Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
measure: Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
measure: Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
measure: Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
measure: Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
measure: Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria
time frame: Up to 72 weeks
arm group label: MM patients receiving elotuzumab
description: Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites.
intervention type: Other
intervention name: No Intervention
description: No Intervention
arm group label: MM patients receiving elotuzumab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell