比较CPT或安慰剂联合沙利度胺和地塞米松治疗复发或难治多发性骨髓瘤的多中心、随机、双盲、对照Ⅲ期临床试验
[Translation] A multicenter, randomized, double-blind, controlled phase III clinical trial comparing CPT or placebo combined with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma
主要目的是评价CPT联合沙利度胺和地塞米松(TD方案)与单用TD方案相比治疗复发或难治的多发性骨髓瘤患者是否具有更好的疗效,主要观察指标是无进展生存期(PFS)。次要目的是评价CPT与沙利度胺和地塞米松(TD方案)联合用药的安全性。
[Translation] The primary objective was to evaluate whether CPT combined with thalidomide and dexamethasone (TD regimen) has better efficacy than TD regimen alone in the treatment of patients with relapsed or refractory multiple myeloma, and the primary observation indicator is progression-free survival (PFS). The secondary objective was to evaluate the safety of CPT combined with thalidomide and dexamethasone (TD regimen).
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