Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

Details

NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Keywords

Non-Hodgkin's Lymphoma Hodgkin Lymphoma Multiple Myeloma Lymphoma Neoplasms, Plasma Cell Dexamethasone Dexamethasone acetate Nivolumab Ipilimumab Daratumumab Pomalidomide BB 1101 Antibodies, Monoclonal Lirilumab Nivolumab monotherapy (Dose Escalation) Nivolumab + Ipilimumab Nivolumab + Lirilumab Nivo + Dara + Pom + Dexa vs. Nivo + Dara Daratumumab vs. Nivolumab + Daratumumab

Eligibility

For people ages 18 years and up

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

Locations

  • Ucsf Fresno
    Fresno California 93701 United States
  • Division Of Hematology & Oncology Ctr. For Health Sciences
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT01592370
Phase
Phase 1/2
Study Type
Interventional
Last Updated