The TOURMALINE-MM1 study will compare oral MLN9708 plus lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
The randomized, double-blind, multi-center study will be conducted in Europe, North America, Latin America and the Asia-Pacific region.
Millennium chief medical officer Karen Ferrante said, "This is the first all oral combination regimen, which includes a proteasome inhibitor and IMiD being studied in multiple myeloma."
Progression-free survival is the primary endpoint while safety, overall survival (OS), OS in high-risk patients, overall response rate, duration of response and time to progression include secondary endpoints.