AsianScientist (Nov. 26, 2013) – Takeda Pharmaceutical Company has initiated enrollment of patients in Japan in an ongoing global Phase III clinical study of its novel oral proteasome inhibitor MLN9708 (ixazomib citrate) in relapsed and/or refractory multiple myeloma.
The Phase III, randomized, double-blind, multi-center, international study will compare MLN9708 with lenalidomide and dexamethasone to placebo as well as lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
The study was initiated in Europe, North America and the Asia-Pacific region in June 2012. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), OS in high-risk patients, overall response rate (ORR), duration of response (DOR), time to progression (TTP), safety, and QOL.
MLN9708 is a proteasome inhibitor and is the first to enter clinical trials as an oral preparation. Currently, Phase III clinical studies are ongoing in newly diagnosed multiple myeloma and in relapsed and/or refractory AL amyloidosis as well as in relapsed and/or refractory multiple myeloma.
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