Multiple myeloma (current protocol) MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
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 - Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). - Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the tolerability of the combination of nivolumab and daratumumab in subjects with relapsed/refractory MM.;Secondary Objective: -To assess the minimal residual disease (MRD) status for MM subjects in each treatment regimen group -To assess overall response rates (ORR) and duration of response (DOR) for MM subjects in each treatment regimen group -To assess progression free survival (PFS) for MM subjects in each treatment regimen group -To characterize the immunogenicity of nivolumab when administered in combination with daratumumab -To characterize the pharmacokinetics of nivolumab when administered in combination with daratumumab;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Up to 100 days after the last dose of study (expected to be no more than 225 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a)Maximum observed serum concentration (Cmax) b)Serum concentration achieved at the end of dosing interval (trough concentration, all participants) [Cmin] c)Time of maximum observed serum concentration (Tmax) d)Area under the plasma concentration time curve from time zero to the last time of the last quantifiable concentration [AUC(0-T)] e)Area under the concentration-time curve in one dosing interval [AUC(TAU)] f)Serum concentration achieved at the end of study drug infusion (Ceoinf) g)Best Overall Response (BOR) h)ORR I)Duration of Objective Response j)Progression Free Survival Rate (PFSR) k)Modified Severity Weighted Assessment Tool (mSWAT) for patients with cutaneous T cell lymphoma l)Immunogenicity as measured by the anti-drug antibody (ADA) status both at sample level and at patient level m)Minimal Residual Disease (MRD) in patients with multiple myeloma receiving nivolumab in combination with daratumumab n)PD-L1 expression;Timepoint(s) of evaluation of this end point: a)b)c)d)e)f) 7 time points up to 20 weeks g)Baseline (within 28 days of treatment), until disease progression in patients, up to week 156 h)Baseline up to week 156 I)Baseline until disease progression in patients with multiple myeloma receiving nivolumab in combination with daratumumab, up to week 156 j)k) Baseline up to week 156 l)Baseline, 6 timepoints up to 120 days after the last dose of study drug m)Up to 41 months n)up to 20 weeks | — |
Countries
Belgium, France, Greece, Italy, Poland, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed