For Healthcare Professionals

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

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About the study

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
    2. More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
    3. Have detectable disease measured by a specific protein in your blood and/or urine
    4. Must consent to bone marrow aspirate or biopsy.

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
    2. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
    3. Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
    4. History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma

    Other protocol defined inclusion/exclusion criteria could apply


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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Non-Hodgkin's Lymphoma,Hodgkin Lymphoma,Multiple Myeloma

    Age (in years)

    18+

    Phase

    Phase 1/Phase 2

    Participants needed

    316

    Est. Completion Date

    Dec 22, 2023

    Treatment type

    Interventional


    Sponsor

    Bristol-Myers Squibb

    ClinicalTrials.gov identifier

    NCT01592370

    Study number

    CA209-039

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