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 |
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.
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.
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
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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13001 E. 17th Pl
Aurora, Colorado 80045
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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450 Brookline Ave
Boston, Massachusetts 2215
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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535 Barnhill Dr
Indianapolis, Indiana 46202
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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3901 Rainbow Blvd
Kansas City, Kansas 66160
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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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
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
Phone: 503-494-4603
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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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