Updated on 2 July 2012
The study is a phase III, randomized, double-blind, multi-center, international study
Singapore: Millennium: The Takeda Oncology Company, has initiated an international phase III clinical trial evaluating MLN9708 in patients with relapsed or refractory multiple myeloma. The multi-center study with MLN9708, an investigational, oral proteasome inhibitor, will be conducted in the Asia Pacific region apart from Europe, North America and Latin America.
MLN9708 is an investigational oral, potent, proteasome inhibitor, which is being studied in multiple myeloma, various hematologic malignancies and solid tumors. It is the first oral proteasome inhibitor to enter clinical trials in patients.
"As the leader in the area of protein homeostasis, Millennium continually strives to develop new therapies and new options to meet the needs of patients dealing with cancer," said Dr Karen Ferrante, chief medical officer, Millennium. "This is the first all oral combination regimen, which includes a proteasome inhibitor and IMiD being studied in multiple myeloma. The initiation of this trial represents another major achievement in advancing the Millennium pipeline."
The study, known as TOURMALINE-MM1, is a phase III, randomized, double-blind, multi-center, international study comparing oral MLN9708 plus lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The primary endpoint is progression-free survival. Secondary endpoints include safety, overall survival, OS in high-risk patients, overall response rate, duration of response and time to progression.