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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:June 27, 2012
End Date:June 15, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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

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.

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

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
We found this trial at
38
sites
Salt Lake City, Utah 84132
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30342
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Atlanta, GA
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 720-848-1776
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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Baltimore, Maryland 21231
Phone: 410-614-0482
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-8437
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Cleveland, Ohio 44195
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Fresno, California 93720
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Gainesville, Florida 32603
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Hackensack, New Jersey 07601
Phone: 551-996-5078
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Impact Migration,
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Impact Migration,
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Phone: 317-278-5623
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-2545
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37920
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1400 Teal Road West
Lafayette, Indiana 47905
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Little Rock, Arkansas 72201
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Long Beach, California 90806
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Miami, Florida 33136
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Milwaukee, Wisconsin 53226
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Murray, Utah 84123
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-3359
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73103
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Omaha, Nebraska 68114
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Omaha, NE
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Orlando, Florida 32804
Phone: 407-303-5871
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Philadelphia, Pennsylvania 19111
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15240
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Phone: 503-494-4603
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Rochester, Minnesota 55905
Phone: 855-776-0015
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1506 South Silicon Way
Saint George, Utah 84770
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Saint Louis, Missouri 63104
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-213-4230
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Skokie, Illinois 60077
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Tampa, Florida 33612
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