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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-039  |   NCT01592370

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

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 - More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant) - Have detectable disease measured by a specific protein in your blood and/or urine - Must consent to bone marrow aspirate or biopsy. Exclusion Criteria: - 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 - 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 - 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 - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Daratumumab vs. Nivolumab + Daratumumab

ASSIGNED INTERVENTION
  • Biological: Daratumumab, Nivolumab

Study Arms

Experimental: Nivo + Dara + Pom + Dexa vs. Nivo + Dara

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Daratumumab
  • Drug: Dexamethasone, Pomalidomide

Study Arms

Experimental: Nivolumab + Ipilimumab

ASSIGNED INTERVENTION
  • Biological: Ipilimumab, Nivolumab

Study Arms

Experimental: Nivolumab + Lirilumab

ASSIGNED INTERVENTION
  • Biological: Lirilumab, Nivolumab

Study Arms

Experimental: Nivolumab monotherapy (Dose Escalation)

ASSIGNED INTERVENTION
  • Biological: Nivolumab

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