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Clinical Trial 19197
Interventions:CC-5013 (Lenalidomide); Elotuzumab; Lenalidomide (Revlimid)
Study Type: Treatment
Phase of Study: Phase II
- Melissa Alsina
A Randomized Parallel Phase 2 Study of Elotuzumab plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression while on Lenalidomide Maintenance for Multiple Myeloma
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.
Primary Objective: Progression free survival with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma patients with serologic relapse/progression while receiving lenalidomide maintenance for each cohort. Secondary Objectives: 1.) Overall response rate (ORR) with elotuzumab and lenalidomide for each cohort. 2.) Minimum response (MR) or better rate with elotuzumab and lenalidomide for each cohort. 3.) Time to next treatment (TTNT) for each cohort. 4. ) Comparison of clinical outcomes (cohort A versus B). 5.) Fc y RIIIa receptor polymorphisms (homozygous for high-affinity V (VV) allele vs. low affinity F (FF) allele). 6.) Determine effect of elotuzumab on phenotypic characteristics of the immune infiltrate and correlate with therapeutic efficacy of elotuzumab.