[Translation] A study evaluating ELRANATAMAB (PF-06863135) + daratumumab + lenalidomide versus daratumumab + lenalidomide + dextrin in subjects with newly diagnosed multiple myeloma who are not eligible for transplantation Open-label, two-arm, multicenter, randomized, phase III study of the efficacy and safety of dexamethasone
主要目的:通过测量 MRD 状态和 PFS 比较 EDR(A 组)与DRd(B 组)的疗效。
关键次要目的:通过测量 OS 比较 EDR(A 组)与 DRd(B 组)的疗效。
次要目的:评价 A 组与 B 组的疗效;确定与达雷妥尤单抗和来那度胺联合治疗时 elranatamab 的安全性和耐药性;评价与达雷妥尤单抗和来那度胺联用时 elranatamab 的PK;评价与达雷妥尤单抗和来那度胺联用时 elranatamab 的免疫原性;评价治疗对受试者 HRQoL 的影响。
三级/探索性目的:了解 EDR、DRd 与受试者 MM 生物学之间的关系;评价与 elranatamab 联用时达雷妥尤单抗和来那度胺的 PK;在数据允许的情况下,探索 elranatamab 暴露量与疗效、安全性和生物标志物终点之间的关联;评估 EDR 治疗对患者报告结局和功能的影响;收集医疗资源利用数据。
[Translation] Primary purpose: To compare the efficacy of EDR (Group A) with that of DRd (Group B) by measuring MRD status and PFS.
Key secondary objectives: To compare the efficacy of EDR (Arm A) versus DRd (Arm B) by measuring OS.
Secondary objectives: To evaluate the efficacy of Arms A and B; to determine the safety and resistance of elranatamab in combination with daratumumab and lenalidomide; to evaluate the efficacy of elranatamab in combination with daratumumab and lenalidomide To evaluate the PK of elranatamab when combined with amines; to evaluate the immunogenicity of elranatamab when combined with daratumumab and lenalidomide; to evaluate the impact of treatment on subjects' HRQoL.
Tertiary/exploratory objectives: Understand the relationship between EDR, DRd and subject MM biology; evaluate the PK of daratumumab and lenalidomide when combined with elranatamab; explore where data permits Association between elranatamab exposure and efficacy, safety, and biomarker endpoints; assess the impact of EDR treatment on patient-reported outcomes and function; and collect healthcare resource utilization data.