A Phase III study of Pomalidomide and low dose Dexamethasone with or without Pembrolizumab (MK-3475) in refractory or relapsed and refractory Multiple Myeloma (rrMM)
The goal of this clinical research study is to learn if pomalidomide, low-dose dexamethasone, and pembrolizumab (also called MK-3475 or KEYTRUDA) taken together can help to control MM better than pomalidomide and dexamethasone without pembrolizumab. The safety of this drug combination will also be studied.
Treatment Location: N/A
Primary Objectives Objective: Compare the Progression Free Survival (PFS) as assessed by CAC blinded central review according to the International Myeloma Working Group response criteria, (IMWG criteria ) between treatment arms. Hypothesis: pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs PFS as assessed by CAC blinded central review using IMWG criteria compared to treatment with pomalidomide and low dose dexamethasone (SOC) alone. Secondary Objective(s) & Hypothesis(es) In subjects with rrMM: (1) Objective: Compare Overall Response Rate (ORR) as assessed by CAC blinded central review using IMWG criteria. Hypothesis : pembrolizumab in combination with pomalidomide and low dose dexamethasone has a higher ORR, as assessed by CAC blinded central review according to IMWG criteria, compared to treatment with pomalidomide and low dose dexamethasone (SOC) alone (2) Objective: To evaluate the safety and tolerability in both treatment arms. (3) Objective: Evaluate Disease Control Rate (DCR) as assessed by CAC blinded central review using IMWG criteria, Duration of Response (DOR) as assessed by CAC blinded central review using IMWG criteria and second Progression Free Survival (PFS2) by investigator assessment. Exploratory Objectives In subjects with rrMM: (1) Objective: To evaluate changes in health-related quality-of-life assessments from baseline using the EORTC QLQ-C30 and QLQ-MY20. (2) Objective: To characterize patient utilities using EuroQol EQ-5D. (3) Objective: To evaluate pharmacokinetic parameters, and the presence of anti-drug antibodies, following intravenous (IV) administration of 200 mg pembrolizumab Q3W, in combination with pomalidomide and low dose dexamethasone. 4) Objective: To identify molecular (genomic, metabolic and/or proteomic) determinants of response or resistance to pembrolizumab and other treatments in this study, so as to define novel predictive and pharmacodynamic biomarkers and understand the mechanism of action of pembrolizumab.
IRB Review and Approval Date: 05/19/2016
Recruitment Status: Closed
Projected Accrual: N/A
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