An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma
NCT ID: NCT01592370
Last Updated: 2025-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
320 participants
INTERVENTIONAL
2012-08-02
2024-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab monotherapy (Dose Escalation)
Nivolumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Nivolumab
Administered by intravenous (IV) infusion
Nivolumab + Ipilimumab
Nivolumab and Ipilimumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Nivolumab
Administered by intravenous (IV) infusion
Ipilimumab
Administered by IV infusion
Nivolumab + Lirilumab
Non-randomized
Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks
Enrollment is closed for this cohort
Nivolumab
Administered by intravenous (IV) infusion
Lirilumab
Administered by IV infusion
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Randomized
Nivolumab:
Cycle 1: 240 mg Day 15 Cycle 2-6: 240 mg Days 1, 15 Cycle 7 \& beyond: 480 mg Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 \& beyond: 16 mg/kg Day 1
Pomalidomide:
4 mg po (by mouth) daily on Days 1 - 21 of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing:
* 40 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants ≤ 75 years old
* 20 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants \> 75 years old
Weeks with daratumumab dosing:
* 20 mg iv before the daratumumab infusion and 20 mg po after the daratumumab infusion in participants ≤ 75 years old
* 16 mg iv before the daratumumab infusion and 4 mg po after the daratumumab infusion in participants \> 75 years old
Enrollment is closed for this cohort
Nivolumab
Administered by intravenous (IV) infusion
Daratumumab
Administered by IV infusion
Pomalidomide
Administered PO
Dexamethasone
Administered PO and by IV infusion
Daratumumab vs. Nivolumab + Daratumumab
Randomized
Nivolumab:
Cycle 1: 240 mg Day 15 Cycle 2 \& beyond: 480 mg Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 \& beyond: 16 mg/kg Day 1
Nivolumab
Administered by intravenous (IV) infusion
Daratumumab
Administered by IV infusion
Interventions
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Nivolumab
Administered by intravenous (IV) infusion
Ipilimumab
Administered by IV infusion
Lirilumab
Administered by IV infusion
Daratumumab
Administered by IV infusion
Pomalidomide
Administered PO
Dexamethasone
Administered PO and by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0035
Clovis, California, United States
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, United States
Local Institution - 0012
Los Angeles, California, United States
Local Institution - 0017
Aurora, Colorado, United States
Local Institution - 013
New Haven, Connecticut, United States
Local Institution - 0023
Orlando, Florida, United States
Local Institution - 0037
Skokie, Illinois, United States
Local Institution - 0019
Indianapolis, Indiana, United States
Local Institution - 0018
Westwood, Kansas, United States
Local Institution - 0003
Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - 0009
Boston, Massachusetts, United States
Local Institution - 0015
Boston, Massachusetts, United States
Local Institution - 0011
Ann Arbor, Michigan, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Local Institution - 0002
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Local Institution - 0033
Omaha, Nebraska, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Local Institution - 0014
Hackensack, New Jersey, United States
Local Institution - 0001
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Local Institution - 0028
Columbus, Ohio, United States
Local Institution - 0006
Portland, Oregon, United States
OHSU Center for Hematologic Malignancies
Portland, Oregon, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Local Institution - 0007
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Local Institution - 0004
Philadelphia, Pennsylvania, United States
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City, Utah, United States
Local Institution - 0005
Salt Lake City, Utah, United States
Local Institution - 0045
Ghent, , Belgium
Local Institution - 0047
Sint-Niklaas, , Belgium
Local Institution
Yvoir, , Belgium
Local Institution - 0043
Poitiers, Vienne, France
Local Institution - 0044
Nantes, , France
Local Institution - 0039
Athens, , Greece
Local Institution
Bologna, , Italy
Local Institution
Chorzów, , Poland
Local Institution - 0040
Poznan, , Poland
Local Institution - 0049
Warsaw, , Poland
Local Institution - 0042
Wroclaw, , Poland
Countries
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References
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Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.
Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-001030-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-039
Identifier Type: -
Identifier Source: org_study_id
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