Clinical trial · Interventional
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
NCT01592370CI-TRIAL-00096726completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daratumumab | Biological | Daratumumab | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Lirilumab | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Nivolumab monotherapy (Dose Escalation)
- description
- Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
- interventionNames
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Nivolumab + Ipilimumab
- description
- Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Nivolumab + Lirilumab
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLesokhin 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. PMID 27269947
- DERIVEDAnsell 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. PMID 25482239