Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full Description

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

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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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

316

Study ID:

NCT01592370

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 31 Locations for this study

See Locations Near You

Local Institution - 0035
Clovis California, 93611, United States
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles California, 90095, United States
Local Institution - 0012
Los Angeles California, 90095, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Yale University School Of Medicine
New Haven Connecticut, 06520, United States
Local Institution - 0023
Orlando Florida, 32804, United States
Local Institution - 0037
Skokie Illinois, 60077, United States
Local Institution - 0019
Indianapolis Indiana, 46202, United States
Local Institution - 0018
Westwood Kansas, 66205, United States
Local Institution - 0003
Baltimore Maryland, 21231, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Local Institution - 0009
Boston Massachusetts, 02215, United States
Local Institution - 0015
Boston Massachusetts, 02215, United States
Local Institution - 0011
Ann Arbor Michigan, 48109, United States
University Of Michigan Health System
Ann Arbor Michigan, 48109, United States
Local Institution - 0002
Rochester Minnesota, 55905, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
Local Institution - 0014
Hackensack New Jersey, 07601, United States
Local Institution - 0001
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Local Institution - 0028
Columbus Ohio, 43210, United States
Local Institution - 0006
Portland Oregon, 97239, United States
OHSU Center for Hematologic Malignancies
Portland Oregon, 97239, United States
Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Local Institution - 0007
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Local Institution - 0004
Philadelphia Pennsylvania, 19111, United States
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City Utah, 84112, United States
Local Institution - 0005
Salt Lake City Utah, 84112, United States
Local Institution - 0045
Gent , 9000, Belgium
Local Institution
Sint-Niklaas , 9100, Belgium
Local Institution
Yvoir , B-553, Belgium
Local Institution - 0043
Poitiers Vienne, 86021, France
Local Institution - 0044
Nantes Cedex 1 , 44000, France
Local Institution - 0039
Athens , 11528, Greece
Local Institution
Bologna , 40138, Italy
Local Institution
Chorzow , 41-50, Poland
Local Institution - 0040
Poznan , 61-84, Poland
Local Institution - 0049
Warszawa , 02-77, Poland
Local Institution - 0042
Wroclaw , 50-36, Poland

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

316

Study ID:

NCT01592370

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

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