[Translation] An open-label, 3-arm, multicenter, randomized Phase III study evaluating the efficacy and safety of ELRANATAMAB (PF-06863135) monotherapy and ELRANATAMAB + daratumumab versus daratumumab + pomalidomide + dexamethasone in subjects with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor
主要研究目的:通过 PFS 测量比较Elranatamab(A 组)与达雷妥尤单抗 + 泊马度胺 + 地塞米松(C 组)的疗效 。 次要研究目的: 1.通过 OS 测量比较 A组与 C组的疗效 2.通过测量 PFS、PFS2、ORR、DOR、CRR、DOCR、TTR、% MRD 阴性和 % 持续 MRD 阴性,比较A 组与 C 组的疗效 3.确定 Elranatamab 单药治疗的安全性和耐受性 4.评价 Elranatamab 的 PK 5.评价 Elranatamab 的免疫原性 6.评价A 组和C 组中治疗对受试者HRQoL 的影响
[Translation] Primary study objective: To compare the efficacy of Elranatamab (Arm A) with Daratumumab + Pomalidomide + Dexamethasone (Arm C) by PFS measurement. Secondary study objectives: 1. To compare the efficacy of Arm A with Arm C by OS measurement 2. To compare the efficacy of Arm A with Arm C by measuring PFS, PFS2, ORR, DOR, CRR, DOCR, TTR, % MRD-negative and % sustained MRD-negative 3. To determine the safety and tolerability of Elranatamab monotherapy 4. To evaluate the PK of Elranatamab 5. To evaluate the immunogenicity of Elranatamab 6. To evaluate the effect of treatment on the HRQoL of subjects in Arm A and Arm C