CEVOLUTION: A Randomized Phase 3 Trial Comparing Cevostamab Plus Pomalidomide and Dexamethasone Versus Standard of Care (SOC) in Relapsed/Refractory Multiple Myeloma (RRMM)
Materials and Methods/Case Presentation/Objective:
Additional inclusion criteria include measurable disease, an ECOG PS of 0 or 1 and informed consent. Prior exposure to pom and BCMA, GPRC5D and/or FcRH5-targeted agents is not allowed. Pts will be randomized 1:1 to cevostamab plus pom-dex (Arm A) or investigator's choice of SOC (Arm B), stratified by number of prior lines (1 vs 2 vs 3), International Staging System stage (1 vs >1) and choice of SOC. In Arm A, step-up doses of cevostamab will be given on Cycle (C) 1 Day (D) 1, C1D2 (or D3 or D4) and C1D8. Target doses (70 mg) will be given on C1D9 (or D10 or D11), D1 and D15 of C2-7 (Q2W) and D1 of C8+ (Q4W). Pom (D1-21) will be given from C2+. In Arm B, pts will receive investigator's choice of either daratumumab plus pom-dex, elotuzumab plus pom-dex or carfilzomib plus dex, with the choice informed by the pts prior treatment exposure and refractoriness to individual classes of agents. In both arms, treatment will continue until disease progression or unacceptable toxicity. The primary objective is to compare the efficacy of cevostamab plus pom-dex vs SOC based on dual primary endpoints of rate of minimal residual disease-negative complete response at the 10-5 level at 9 months and progression-free survival. Key secondary endpoints are the rate of very good partial response or better, overall survival, change from baseline in the disease symptom scale of the EORTC QLQ-MY20 at 9 months and change from baseline in the global health status/quality of life scale of the EORTC QLQ-C30 at 9 months. Safety, pharmacokinetics, immunogenicity and pharmacodynamics will also be assessed. CEVOLUTION will enroll ~380 pts across ~140 global sites. Enrollment is ongoing as of June 23, 2026.
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