relapsed and refractory Multiple Myeloma MedDRA version: 18.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Elotuzumab
Product Code: BMS-901608
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Elotuzumab
Current Sponsor code: BMS-901608
Other descripti
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) = 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination. (2) Documented refractory or relapsed and refractory multiple myeloma (3) Refractory to proteosome inhibitor and lenalidomide, and to their last treatment (4) Relapsed and refractory patients had achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment. (5) Measurable disease at screening (6) Eastern Cooperative Oncology Group (ECOG) performance status = 2 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 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: (1) Active plasma cell leukemia (2) Prior treatment with pomalidomide (3) Unable to tolerate thromboembolic prophylaxis while on the study (4) Prior autologous stem cell transplant within 12 weeks (5) Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare progression free survival (PFS) between treatment arms;Secondary Objective: - To compare objective response rate between treatment arms - To compare overall survival between treatment arms;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: PFS will be defined as the time, in months, from randomization to the date of the firstdocumented tumor progression or death due to any cause.Time Frame: Every 4 weeks relative to the first dose of study medication, until progressive disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Objective Response Rate (ORR) is defined as the proportion of randomized subjects who achieve a best response of partial response (PR) or better.(2) Overall Survival (OS) defined as the period of time from randomization until the date of death or last known alive date.;Timepoint(s) of evaluation of this end point: (1) ORR - All response endpoints will be assessed every 4 weeks after the start of study therapy, and until progressive disease occurs. (2) OS will be assessed every 12 weeks, or more frequently, in the Follow Up Phase of the trial. | — |
Countries
Canada, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed