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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Hodgkin Lymphoma
Multiple Myeloma
Non-Hodgkin's Lymphoma

Treatments

Biological: Nivolumab
Biological: Lirilumab
Biological: Daratumumab
Biological: Ipilimumab
Drug: Dexamethasone
Drug: Pomalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01592370
2018-001030-17 (EudraCT Number)
CA209-039

Details and patient eligibility

About

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.

Full description

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

Enrollment

316 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

316 participants in 5 patient groups

Nivolumab monotherapy (Dose Escalation)
Experimental group
Description:
Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Treatment:
Biological: Nivolumab
Nivolumab + Ipilimumab
Experimental group
Description:
Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Treatment:
Biological: Ipilimumab
Biological: Nivolumab
Nivolumab + Lirilumab
Experimental group
Description:
Non-randomized Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks Enrollment is closed for this cohort
Treatment:
Biological: Lirilumab
Biological: Nivolumab
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Experimental group
Description:
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
Treatment:
Drug: Dexamethasone
Drug: Pomalidomide
Biological: Daratumumab
Biological: Nivolumab
Daratumumab vs. Nivolumab + Daratumumab
Experimental group
Description:
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
Treatment:
Biological: Daratumumab
Biological: Nivolumab

Trial documents
2

Trial contacts and locations

43

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Data sourced from clinicaltrials.gov

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