<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/NCT04458831</url>
  </required_header>
  <id_info>
    <org_study_id>OBS16577</org_study_id>
    <nct_id>NCT04458831</nct_id>
  </id_info>
  <brief_title>A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)</brief_title>
  <acronym>IONA-MM</acronym>
  <official_title>A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients&#xD;
      with RRMM in routine clinical practice, within 12 months&#xD;
&#xD;
      To assess other effectiveness parameters such as progression free survival (PFS), PFS rate&#xD;
      (PFSR), duration of response (DoR), time to response, time and intent to first subsequent&#xD;
      therapy, rate of very good partial response or better, rate of complete response (CR) or&#xD;
      better of isatuximab patients with RRMM in routine clinical practice&#xD;
&#xD;
      To assess the profile of patients (demographic, disease characteristics, comorbidities and&#xD;
      prior MM treatment history) who are treated with isatuximab in routine clinical practice&#xD;
&#xD;
      To describe safety of isatuximab in routine clinical practice (based on adverse event [AE]&#xD;
      reporting)&#xD;
&#xD;
      To assess quality of life (QoL) using the European Organization for Research and Treatment of&#xD;
      Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma&#xD;
      questionnaire module (QLQ MY20)&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      Not applicable&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Duration per participant is 2.5 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">February 23, 2026</completion_date>
  <primary_completion_date type="Anticipated">February 23, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Months</target_duration>
  <primary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>12 months</time_frame>
    <description>The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression free survival rate (PFSR)</measure>
    <time_frame>up to 18 months</time_frame>
    <description>The proportion of patients who do not progress and are alive at specific time intervals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>12 months</time_frame>
    <description>Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR , VGPR , CR , or sCR to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to response (TTR)</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first subsequent anti-myeloma therapy</measure>
    <time_frame>30 months</time_frame>
    <description>Time from the initiation of isatuximab until the start of subsequent therapy or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of very good partial response or better</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Comprising VGPR, CR, and sCR within 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of complete response (CR) or better</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Comprising CR and sCR responses within 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse events</measure>
    <time_frame>1 month after end of treatment</time_frame>
    <description>Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30)</measure>
    <time_frame>through end of treatment (up to approximately 2 years)</time_frame>
    <description>The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)</measure>
    <time_frame>through end of treatment (up to approximately 2 years)</time_frame>
    <description>The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Plasma Cell Myeloma</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isatuximab SAR650984</intervention_name>
    <description>Pharmaceutical form: solution for infusion&#xD;
Route of administration: intravenous</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <other_name>Sarclisa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Pharmaceutical form: oral</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <other_name>Pomalyst</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Pharmaceutical form: oral</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carfilzomib</intervention_name>
    <description>Pharmaceutical form: solution for infusion</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The source population for this study will be patients with a diagnosis of RRMM recruited&#xD;
        from participating sites in Asia, Europe, Latin America, and North America. The study will&#xD;
        aim to enroll up to approximately 1200 adult patients with a recorded diagnosis of RRMM&#xD;
        from up to 150 sites. A subset of patients from sites, limited to the US only, will be&#xD;
        recruited (up to 100 patients out of 1200), for enrichment by leveraging existing&#xD;
        electronic medical record (EMR) technologies coupled with the electronic case report forms&#xD;
        (eCRFs).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Age ≥18 years&#xD;
&#xD;
          -  Patients with RRMM who have at least one prior line of therapy&#xD;
&#xD;
          -  Patients for whom the treating physician has made the decision to initiate isatuximab&#xD;
             per routine practice and independently of the purpose of the study; for&#xD;
             retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of&#xD;
             three months prior to study enrollment&#xD;
&#xD;
          -  Able to understand and complete the study-related questionnaires&#xD;
&#xD;
          -  Patient must have given signed informed consent prior to study start. For&#xD;
             retrospectively enrolled patients who are deceased at the date of enrollment into the&#xD;
             study, a waiver of consent will be required; patients who have started and stopped&#xD;
             treatment up to three months before ICF are eligible .&#xD;
&#xD;
        Most important exclusion criteria for potential participants:&#xD;
&#xD;
        Patients who are receiving isatuximab for an indication other than RRMM&#xD;
&#xD;
          -  Patients who have received any other investigational drug or prohibited therapy for&#xD;
             this study within 28 days or five half-lives from randomization, whichever is longer&#xD;
&#xD;
          -  Patients having contraindication to the isatuximab summary of product characteristics&#xD;
             (SMPC) or package insert (PI)&#xD;
&#xD;
          -  Patients having contraindications as noted in the drug-specific local isatuximab&#xD;
             SMPC/PI of combination drugs&#xD;
&#xD;
          -  Any country-related specific regulation that would prevent the patient from entering&#xD;
             the study&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
    <phone>800-633-1610</phone>
    <phone_ext>option 6</phone_ext>
    <email>Contact-Us@sanofi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Investigational Site Number 8400021</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400009</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400030</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400007</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400023</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400025</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400026</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400019</name>
      <address>
        <city>Garden City</city>
        <state>Kansas</state>
        <zip>67846</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400010</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400006</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>65613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400016</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400017</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400024</name>
      <address>
        <city>Howell</city>
        <state>New Jersey</state>
        <zip>07731</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400018</name>
      <address>
        <city>Little Silver</city>
        <state>New Jersey</state>
        <zip>07739</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400028</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400015</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44708</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400012</name>
      <address>
        <city>Massillon</city>
        <state>Ohio</state>
        <zip>44646</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400020</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400011</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400002</name>
      <address>
        <city>Watertown</city>
        <state>South Dakota</state>
        <zip>57201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400013</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400004</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 0400002</name>
      <address>
        <city>Steyr</city>
        <zip>4400</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 0400003</name>
      <address>
        <city>Wien</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 5600001</name>
      <address>
        <city>Anderlecht</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 5600002</name>
      <address>
        <city>Sint-Niklaas</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560001</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haiyuan First Road, Futian District</last_name>
      <phone>8618910245956</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500007</name>
      <address>
        <city>Argenteuil</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500006</name>
      <address>
        <city>Chambéry</city>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500012</name>
      <address>
        <city>Essey-lès-Nancy</city>
        <zip>54270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500013</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500004</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2500009</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500008</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500010</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500001</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500005</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500003</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2500011</name>
      <address>
        <city>Vannes</city>
        <zip>56007</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760014</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760016</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760025</name>
      <address>
        <city>Bad Liebenwerda</city>
        <zip>04924</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760020</name>
      <address>
        <city>Bamberg</city>
        <zip>96052</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760018</name>
      <address>
        <city>Bayreuth</city>
        <zip>95445</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760003</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760022</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760041</name>
      <address>
        <city>Berlin</city>
        <zip>10437</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760009</name>
      <address>
        <city>Berlin</city>
        <zip>10715</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760007</name>
      <address>
        <city>Donauwörth</city>
        <zip>86609</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational site number 2760001</name>
      <address>
        <city>Dortmund</city>
        <zip>44263</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760002</name>
      <address>
        <city>Dresden</city>
        <zip>01127</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760035</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760010</name>
      <address>
        <city>Frankfurt</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760037</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760015</name>
      <address>
        <city>Goslar</city>
        <zip>38642</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760012</name>
      <address>
        <city>Hanover</city>
        <zip>30449</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760013</name>
      <address>
        <city>Herrsching Am Ammersee</city>
        <zip>82211</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760034</name>
      <address>
        <city>Koeln</city>
        <zip>50677</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760026</name>
      <address>
        <city>Kulmbach</city>
        <zip>95326</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760008</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760011</name>
      <address>
        <city>Magdeburg</city>
        <zip>39104</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760038</name>
      <address>
        <city>Marburg</city>
        <zip>35037</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760006</name>
      <address>
        <city>Muenchen</city>
        <zip>81241</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760042</name>
      <address>
        <city>Mutlangen</city>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760021</name>
      <address>
        <city>Oldenburg</city>
        <zip>26121</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760036</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760039</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760040</name>
      <address>
        <city>Stolberg</city>
        <zip>52222</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760031</name>
      <address>
        <city>Weilheim</city>
        <zip>82362</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2760019</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3440001</name>
      <address>
        <city>Hong Kong</city>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tang Karen</last_name>
      <phone>+85222555859</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3800005</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3800007</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3800001</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3800002</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3800010</name>
      <address>
        <city>Treviso</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920010</name>
      <address>
        <city>Fukuoka</city>
        <zip>815-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920002</name>
      <address>
        <city>Kamogawa</city>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920007</name>
      <address>
        <city>Kashiwa</city>
        <zip>277-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920004</name>
      <address>
        <city>Minato-Ku</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920013</name>
      <address>
        <city>Minato-Ku</city>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nishishimbashi</last_name>
      <phone>+81334331111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920005</name>
      <address>
        <city>Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920009</name>
      <address>
        <city>Osaka</city>
        <zip>543-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920012</name>
      <address>
        <city>Sapporo</city>
        <zip>003-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920008</name>
      <address>
        <city>Shibukawa</city>
        <zip>377-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920006</name>
      <address>
        <city>Shibuya</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920003</name>
      <address>
        <city>Sunto-gun</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920011</name>
      <address>
        <city>Suwa</city>
        <zip>392-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920001</name>
      <address>
        <city>Yamagata-shi</city>
        <zip>990-9585</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5820001</name>
      <address>
        <city>Dordrecht</city>
        <zip>3318AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400001</name>
      <address>
        <city>Hato Rey</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400029</name>
      <address>
        <city>San juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240005</name>
      <address>
        <city>León</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240006</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240003</name>
      <address>
        <city>Palma De Mallorca</city>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240009</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240007</name>
      <address>
        <city>San Cristobal de La laguna</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7240004</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5760003</name>
      <address>
        <city>Baden</city>
        <zip>5404</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5760001</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5760002</name>
      <address>
        <city>Zürich</city>
        <zip>8063</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7840002</name>
      <address>
        <city>Abu Dhabi</city>
        <zip>11393</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mustaqeem Siddiqui</last_name>
      <phone>+971582995671</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7840001</name>
      <address>
        <city>Abu Dhabi</city>
        <zip>7400</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohanad Diab</last_name>
      <phone>+971509359632</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8260004</name>
      <address>
        <city>Huddersfield</city>
        <zip>HD3 3EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8260003</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8260002</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8260005</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Arab Emirates</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- 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/NCT04458831
org study id: OBS16577
nct id: NCT04458831
lead sponsor: 
has dmc: No
is fda regulated device: No
Primary Objective:

      To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients
      with RRMM in routine clinical practice, within 12 months

      To assess other effectiveness parameters such as progression free survival (PFS), PFS rate
      (PFSR), duration of response (DoR), time to response, time and intent to first subsequent
      therapy, rate of very good partial response or better, rate of complete response (CR) or
      better of isatuximab patients with RRMM in routine clinical practice

      To assess the profile of patients (demographic, disease characteristics, comorbidities and
      prior MM treatment history) who are treated with isatuximab in routine clinical practice

      To describe safety of isatuximab in routine clinical practice (based on adverse event [AE]
      reporting)

      To assess quality of life (QoL) using the European Organization for Research and Treatment of
      Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma
      questionnaire module (QLQ MY20)

      Secondary Objective:

      Not applicable
Duration per participant is 2.5 years
observational model: Cohort
time perspective: Prospective
measure: Overall response rate (ORR)
time frame: 12 months
description: The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria
measure: Progression free survival (PFS)
time frame: up to 18 months
description: Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first.
measure: Progression free survival rate (PFSR)
time frame: up to 18 months
description: The proportion of patients who do not progress and are alive at specific time intervals
measure: Duration of response (DoR)
time frame: 12 months
description: Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR , VGPR , CR , or sCR to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first.
measure: Time to response (TTR)
time frame: 12 months
description: Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria
measure: Time to first subsequent anti-myeloma therapy
time frame: 30 months
description: Time from the initiation of isatuximab until the start of subsequent therapy or death.
measure: Rate of very good partial response or better
time frame: up to 12 months
description: Comprising VGPR, CR, and sCR within 12 months
measure: Rate of complete response (CR) or better
time frame: up to 12 months
description: Comprising CR and sCR responses within 12 months
measure: Number of Participants with Adverse events
time frame: 1 month after end of treatment
description: Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion
measure: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30)
time frame: through end of treatment (up to approximately 2 years)
description: The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact.
measure: Change from Baseline in the EORTC Multiple Myeloma Specific Quality of Life 20 item questionnaire (QLQ MY20)
time frame: through end of treatment (up to approximately 2 years)
description: The EORTC QLQ-MY20 is a validated, self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item).
arm group label: Cohort 1
description: Patients with multiple myeloma (MM) and are considered as RRMM according to the International Myeloma Working Group (IMWG) criteria
intervention type: Drug
intervention name: isatuximab SAR650984
description: Pharmaceutical form: solution for infusion
Route of administration: intravenous
arm group label: Cohort 1
other name: Sarclisa
intervention type: Drug
intervention name: Pomalidomide
description: Pharmaceutical form: oral
arm group label: Cohort 1
other name: Pomalyst
intervention type: Drug
intervention name: Dexamethasone
description: Pharmaceutical form: oral
arm group label: Cohort 1
intervention type: Drug
intervention name: Carfilzomib
description: Pharmaceutical form: solution for infusion
arm group label: Cohort 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
last name: Trial Transparency email recommended (Toll free number for US & Canada)
phone: 800-633-1610
phone ext: option 6
email: Contact-Us@sanofi.com
facility: 
status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
country: Austria
country: Belgium
country: China
country: France
country: Germany
country: Hong Kong
country: Italy
country: Japan
country: Netherlands
country: Puerto Rico
country: Spain
country: Switzerland
country: United Arab Emirates
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Pomalidomide
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org