[Translation] A study comparing MEZIGDOMIDE (CC-92480), bortezomib, and dexamethasone (MEZIVd) with pomalidomide, bortezomib, and dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) Phase III, Phase 2, randomized, multicenter, open-label study of (PVd): SUCCESSOR-1
主要目的:
在复发性或难治性多发性骨髓瘤(RRMM)受试者中比较Mezigdomide(CC-92480)(又名BMS-986348)、硼替佐米和地塞米松(MeziVd)与泊马度胺、硼替佐米和地塞米松(PVd)的无进展生存期(PFS)
次要目的:
1在第1阶段,确定Mezigdomide联合硼替佐米和地塞米松在研究第2阶段继续使用的剂量在第1阶段,确定Mezigdomide联合硼替佐米和地塞米松的血浆浓度
2在RRMM受试者中比较MeziVd与PVd的总生存期(OS)
3在接受MeziVd治疗的RRMM受试者中评价与PVd相比的其他疗效参数
4评估MeziVd治疗受试者与PVd治疗受试者的微小残留病(MRD)阴性率
5在RRMM受试者中评价MeziVd与PVd相比的安全性
6在随机分组至第2阶段的受试者中,使用欧洲癌症研究和治疗组织-生活质量C30问卷(EORTC QLQ-C30)和欧洲生活质量多发性骨髓瘤模块(EORTC QLQ-MY20)评价接受MeziVd治疗与PVd比较的受试者的癌症相关症状和健康相关生活质量(HRQoL)。
[Translation] main purpose:
Comparing mezigdomide (CC-92480) (also known as BMS-986348), bortezomib, and dexamethasone (MeziVd) versus pomalidomide, boron in subjects with relapsed or refractory multiple myeloma (RRMM) Progression-free survival (PFS) with tezomib and dexamethasone (PVd)
Secondary purpose:
1 In Phase 1, to determine the dose of mezigdomide in combination with bortezomib and dexamethasone to be continued in Phase 2 of the study. In Phase 1, to determine the plasma concentrations of mezigdomide in combination with bortezomib and dexamethasone.
2 Comparing overall survival (OS) of MeziVd versus PVd in RRMM subjects
3 To evaluate additional efficacy parameters compared with PVd in RRMM subjects treated with MeziVd
4 Evaluate the minimal residual disease (MRD) negative rate in MeziVd-treated subjects versus PVd-treated subjects
5 Evaluating the safety of MeziVd compared with PVd in RRMM subjects
6 Among subjects randomized to Phase 2 who received MeziVd were evaluated using the European Organization for Research and Treatment of Cancer-Quality of Life C30 Questionnaire (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) Cancer-related symptoms and health-related quality of life (HRQoL) in subjects treated compared with PVd.