Available IPD datapackage for study 'A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma'

The China Continuation of Study C16010 was a randomized, double-blind, placebo-controlled evaluation of ixazomib or placebo combined with lenalidomide and dexamethasone (LenDex) in patients with relapsed and/or refractory multiple myeloma (RRMM) in China. The primary purpose of the China continuation was to allow evaluation of efficacy, to assess any emerging safety signals, to provide characterization of the PK properties, and to provide sufficient evidence to support registration of Ixazomib in China. After the primary analysis of PFS occurred in July 2015, the study continued in a double-blind, placebo-controlled manner to obtain mature overall survival (OS) information. A subset of 20 patients were included in the PK portion of the study.

C16010研究中国延续性试验是一项针对中国复发和/或难治性多发性骨髓瘤（relapsed and/or refractory multiple myeloma, RRMM）患者的随机、双盲、安慰剂对照研究，旨在评估伊沙佐米（ixazomib）或安慰剂联合来那度胺与地塞米松（LenDex）的治疗方案。该试验的主要研究目的包括：评估治疗疗效、识别新发安全性信号、表征药代动力学（Pharmacokinetics, PK）特性，以及获取足够证据以支持伊沙佐米（ixazomib）在中国的注册申报。2015年7月完成无进展生存期（Progression-Free Survival, PFS）的初步分析后，该研究继续以双盲、安慰剂对照的方式开展，以获取成熟的总生存期（overall survival, OS）数据。本研究的药代动力学亚组共纳入20例患者。