The randomized, placebo-controlled, double-blind Phase 3 clinical trial TOURMALINE-MM4 showed significant improvement in Progression-Free Survival (PFS) of Ixazomib (commercialised by Takeda as Ninlaro) as first line maintenance therapy versus placebo in adult myeloma patients not treated with stem cell transplantation. This clinical trial is the first industry sponsored phase 3 trial to explore the concept of “switch” maintenance, the use of medicines not included in initial induction therapy, in this setting.
More than 700 patients were involved in TOURMALINE-MM4 that showed patients assigned single-agent ixazomib achieved significantly longer PFS than those assigned placebo.
Ixazomib is an oral proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of myeloma patients who have received at least one prior therapy.