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NCT01592370CompletedPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
320 (actual)
First submitted
3 May 2012
Start date
2 Aug 2012
Primary completion date
25 Sept 2020
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT01592370
EudraCT number
2018-001030-17

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 320
  • From 2 Aug 2012 to the primary completion date, 25 Sept 2020
  • 43 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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
  • 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

Who the study is looking for

  • 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.

Criteria the registry did not label

  • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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GhentBelgiumUnknown status
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Sint-NiklaasBelgiumUnknown status
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YvoirBelgiumUnknown status
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NantesFranceUnknown status
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PoitiersFranceUnknown status
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AthensGreeceUnknown status
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BolognaItalyUnknown status
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ChorzówPolandUnknown status
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PoznanPolandUnknown status
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WarsawPolandUnknown status
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WroclawPolandUnknown status
University of Michigan Health System
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Ann ArborUnited StatesUnknown status
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Ann ArborUnited StatesUnknown status
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AuroraUnited StatesUnknown status
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BaltimoreUnited StatesUnknown status
The Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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BostonUnited StatesUnknown status
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ClovisUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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HackensackUnited StatesUnknown status
John Theurer Cancer Center
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HackensackUnited StatesUnknown status
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IndianapolisUnited StatesUnknown status
Division Of Hematology & Oncology Ctr. For Health Sciences
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Los AngelesUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
Abramson Cancer Center
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PhiladelphiaUnited StatesUnknown status
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PortlandUnited StatesUnknown status
OHSU Center for Hematologic Malignancies
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PortlandUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
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RochesterUnited StatesUnknown status
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Salt Lake CityUnited StatesUnknown status
Huntsman Cancer Institute At The Univ. Of Utah
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Salt Lake CityUnited StatesUnknown status
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SkokieUnited StatesUnknown status
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WestwoodUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.