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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: In review
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Heidi Neuburger
Phone: 317-111-1111
Email: hneuburg@iupui.edu

Kansas

Fairway
University of Kansas Clinical Research Center
Status: Active
Name Not Available
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Ivan M. Borrello
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: David E. Avigan
Phone: 617-667-9925
Email: davigan@bidmc.harvard.edu
Dana-Farber Cancer Institute
Status: Active
Contact: Philippe Armand
Phone: 866-790-4500
Email: parmand@partners.org

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Alexander M. Lesokhin
Phone: 212-639-7202
Email: lesokhia@mskcc.org

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Trial Objectives and Outline

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

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-039
Secondary IDs NCI-2012-02776, 2018-001030-17
Clinicaltrials.gov ID NCT01592370