a study on Multiple Myeloma
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.
A Phase Ib Study of SAR650984 (Anti-CD38 mAb) in Combination With Carfilzomib for the Treatment of Relapsed or Refractory Multiple Myeloma
Multiple Myeloma Relapsed Refractory
Open to people ages up to 18 years
Diagnosis of MM and documentation of treatment with an IMiD® and proteasome inhibitor. Must have had 2 prior regimens/lines of therapy but there is no maximum number of prior regimens and prior autologous bone marrow transplant is acceptable if
12 weeks from transplantation. A line of therapy is defined as a course of therapy that is not interrupted by progressive disease. For example, induction therapy,autologous stem cell transplantation, and maintenance therapy without intervening progressive disease is one line of therapy.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Inclusion Clinical Laboratories Criteria
Known active infection requiring parenteral or oral anti-infective treatment, once a patient has completed antibiotics and symptoms of infection have resolved to
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