Quick Take: Oral Ixazomib Maintenance Following Autologous Stem Cell Transplantation (TOURMALINE-MM3): A Double-Blind, Randomised, Placebo-Controlled Phase 3 Trial
Autologous stem cell transplantation (ASCT) is commonly used in the treatment of multiple myeloma, though relapse is extremely common. Ixazomib is a proteasome inhibitor that has been suggested as a possible maintenance therapy for patients with multiple myeloma after they complete ASCT. In this multicenter, double-blind, randomized phase 3 study, 656 patients with newly diagnosed symptomatic multiple myeloma who had experienced a partial or complete response after receiving the current standard of care, including ASCT and high dose melphalan, were randomized to receive weekly oral ixazomib in 28-day cycles for 2 years, with a dose increase from 3 milligrams to 4 milligrams in cycle 5 if well tolerated, or placebo, to assess the safety and efficacy of ixazomib as maintenance therapy following ASCT. Researchers found that progression-free survival was significantly longer in the group treated with ixazomib, as compared to placebo (26.5 months vs. 21.3 months, HR 0.72, 95% CI 0.58 to 0.89, p=0.0023). Similar rates of second malignancies were observed between the two groups. Serious adverse event rates were also similar between the two groups. Investigators therefore concluded that maintenance ixazomib therapy results in prolonged progression-free survival after ASCT in patients with newly diagnosed multiple myeloma.
Click to read the study in Lancet
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