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An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab, With or Without Pomalidomide and Dexamethasone, in Patients With Multiple Myeloma

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01592370
First received: May 3, 2012
Last updated: June 26, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to determine the side effects of treatment with Nivolumab by itself or in combination in patients with relapsed/ refractory lymphoma or multiple myeloma.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Hodgkin Lymphoma Multiple Myeloma Biological: Nivolumab Biological: Ipilimumab Biological: Lirilumab Biological: Daratumumab Drug: Pomalidomide Drug: Dexamethasone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Multiple Phase 1 Safety Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and tolerability of Nivolumab alone and in combination as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities, and laboratory test abnormalities [ Time Frame: Up to 100 days after the last dose of study (expected to be no more than 225 weeks) ]

Secondary Outcome Measures:
  • Maximum observed serum concentration (Cmax) of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Serum concentration achieved at the end of dosing interval (trough concentration, all patients) [Cmin] of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Time of maximum observed serum concentration (Tmax) of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration [AUC(0-T)] of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Serum concentration achieved at the end of study drug infusion (Ceoinf) of Nivolumab, Ipilimumab and Lirilumab [ Time Frame: 7 time points up to 20 weeks ]
  • Best Overall Response (BOR) [ Time Frame: Baseline (within 28 days of treatment), until disease progression in patients, up to week 156 ]
    BOR is defined as the best response designation over the study as a whole, recorded between the date of first dose and the last tumor assessment prior to subsequent therapy

  • Objective Response Rate (ORR) [ Time Frame: Baseline up to week 156 ]
    ORR is defined as the proportion of patients whose BOR is either partial response (PR) or complete response (CR) divided by the number of treated patients

  • Duration of Objective Response [ Time Frame: Baseline until disease progression in patients with multiple myeloma receiving nivolumab in combination with daratumumab, up to week 156 ]
    Duration of response is defined as the time when the measurement criteria are first met for objective response until the date of documented disease progression or death. For patients who neither progress nor die, the duration of response will be censored at the date of their last disease assessment

  • Progression Free Survival Rate (PFSR) [ Time Frame: Baseline up to week 156 ]
    Progression free survival (PFS) is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first

  • Modified Severity Weighted Assessment Tool (mSWAT) for patients with cutaneous T cell lymphoma [ Time Frame: Baseline up to week 156 ]
  • Immunogenicity of Nivolumab, Ipilimumab and Lirilumab as measured by the anti-drug antibody (ADA) status both at sample level and at patient level [ Time Frame: Baseline, 6 timepoints up to 120 days after the last dose of study drug ]
  • Minimal Residual Disease (MRD) for in patients with multiple myeloma receiving nivolumab in combination with daratumumab [ Time Frame: Up to 41 months ]

Estimated Enrollment: 375
Actual Study Start Date: June 27, 2012
Estimated Study Completion Date: March 16, 2020
Estimated Primary Completion Date: October 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Cohort 1-Nivolumab monotherapy (Dose Escalation)

Nivolumab solution intravenously as specified

Enrollment is closed for Arm 1

Non-randomized

Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Arm 2: Cohort 1-Nivolumab + Ipilimumab / Lirilumab

Nivolumab and Ipilimumab or Lirilumab solution intravenously as specified

Enrollment is closed for Arm 2

Non-randomized

Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX010
Biological: Lirilumab
Other Name: BMS-986015
Experimental: Daratumumab

Experimental: Arm 3: Nivolumab and Daratumumab

Randomized

Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Biological: Daratumumab
Other Name: Darzalex
Experimental: Nivolumab, Daratumumab, Pomalidomide, Dexamethasone
Randomized
Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Biological: Daratumumab
Other Name: Darzalex
Drug: Pomalidomide
Other Name: Pomalyst
Drug: Dexamethasone
Other Name: Intensol

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Relapsed or Unresponsive to prior treatment for multiple myeloma
  • ≥2 courses of therapy, including at least 2 consecutive cycles of each immunomodulatory agent (IMiD) and a proteasome inhibitor (PI) alone or in combination
  • 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 a 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), amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
  • No prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or with pomalidomide, 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592370

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 27 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01592370     History of Changes
Other Study ID Numbers: CA209-039
Study First Received: May 3, 2012
Last Updated: June 26, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Pomalidomide
Nivolumab
Daratumumab
Thalidomide
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on June 28, 2017