Takeda Pharmaceutical Company has began its TOURMALINE-MM2 phase 3 trial of MLN9708 in patients with newly diagnosed multiple myeloma.
Being studied in multiple myeloma, various other hematologic malignancies and solid tumours, the investigational MLN9708 is the first oral proteasome inhibitor to enter clinical trials.
Takeda oncology therapeutic unit head Karen Ferrante said that starting of the frontline myeloma trial represents another first in the development of MLN9708.
"The TOURMALINE-MM2 study is the first all oral triplet combination regimen including both a proteasome inhibitor and an IMiD to be investigated in newly diagnosed myeloma patients," Ferrante said.
Designed to assess MLN9708 in combination with lenalidomide and dexamethasone against placebo plus lenalidomide and dexamethasone once a week, the trial will be carried out on patients with newly diagnosed multiple myeloma and who are not candidates for transplant.
The randomised, double-blind, international study with MLN9708 is scheduled to be conducted in Europe and North America.
Progression-free survival (PFS) is the primary endpoint of the multi-centre study, while the key secondary endpoints include safety, rate of complete response (CR), pain response and overall survival (OS).
In 2012, the company initiated two global phase 3 trials, TOURMALINE-MM1 and TOURMALINE-AL1.
TOURMALINE-MM1 is designed to study MLN9708 in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma, whereas TOURMALINE-AL1 investigates MLN9708 along with dexamethasone in patients with relapsed or refractory light chain AL amyloidosis.
Image: Takeda is investigating first oral proteasome inhibitor in patients newly diagnosed with multiple myeloma. Photo: courtesy of J o.