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

Completed · Phase 1/Phase 2

Conditions studied: Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma

In brief

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 facts

Study ID

NCT01592370

Run by

Bristol-Myers Squibb

People needed

320

Starts

2012-08-02

Expected to finish

2024-07-09

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution - 0035 — Clovis, California, United States
• Division Of Hematology & Oncology Ctr. For Health Sciences — Los Angeles, California, United States
• Local Institution - 0012 — Los Angeles, California, United States
• Local Institution - 0017 — Aurora, Colorado, United States
• Local Institution - 013 — New Haven, Connecticut, United States
• Local Institution - 0023 — Orlando, Florida, United States
• Local Institution - 0037 — Skokie, Illinois, United States
• Local Institution - 0019 — Indianapolis, Indiana, United States
• Local Institution - 0018 — Westwood, Kansas, United States
• Local Institution - 0003 — Baltimore, Maryland, United States
• The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Local Institution - 0009 — Boston, Massachusetts, United States
• Local Institution - 0015 — Boston, Massachusetts, United States
• Local Institution - 0011 — Ann Arbor, Michigan, United States
• University Of Michigan Health System — Ann Arbor, Michigan, United States
• Local Institution - 0002 — Rochester, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Local Institution - 0033 — Omaha, Nebraska, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• Local Institution - 0014 — Hackensack, New Jersey, United States
• Local Institution - 0001 — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Local Institution - 0028 — Columbus, Ohio, United States
• Local Institution - 0006 — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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