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

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Overview

The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug called nivolumab. This study will determine the safety in subjects that receive nivolumab when given in combination with daratumumab, or dartartumumab alone in relapsed and/or refractory multiple myeloma.

Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. It has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers.

Daratumumab is a human CD38-directed monoclonal antibody and is approved as monotherapy for third line treatment of MM patients who failed prior therapy.

Another purpose of this study is to evaluate the low-level disease in your blood, urine and bone marrow (minimal residual disease), percentage of patients whose cancer shrinks or disappears after treatment (overall response rate), how long your body responds (duration of response), how long you stay free of disease (progression free survival), your bodies immune response to nivolumab, and how nivolumab works in body.

BMS hopes to use the data from this study together with data from other clinical studies using these investigational drugs to determine the most effective combination of nivolumab for further study.

SparkCures ID 222
Trial Phase Phase 1/2
Enrollment 60 Patients
Treatments
Trial Sponsors
  • Bristol Myers Squibb
NCT Identifier

NCT01592370

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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