Dataset from 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.