This study will be conducted as a standard Phase 1b, open-label, multi-center study of patients with relapsed and/or refractory Myeloma who have received at least two prior therapeutic treatments or regimens. Throughout the Phase I portion of this study, a standard 3+3 dose escalation design will be utilized. Two dosing cohorts will evaluate escalating doses SAR650984 (5mg/kg and 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose Carfilzomib (20-27 mg/mg2). Once a safe dose is established, an expansion cohort will further evaluate safety and begin to assess activity of this combination (SAR650984 (5mg/kg or 10 mg/kg Day 1 and 15 of each 28-day cycle) with standard dose Carfilzomib). During the dose escalation portion of the study, the DLT period will be the first cycle (28 days) or from Day 1 through Day 28 of initial study treatment. Expansion Phase Cohort An expansion cohort will begin once the MTD of SAR650984 plus standard dose Carfilzomib is established. The Expansion Cohort will enroll 18 patients for additional safety and preliminary efficacy data of SAR650984 plus Carfilzomib at the MTD.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Clinical Laboratories Criteria
The following is a listing of trial locations that are open and accepting patients.
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