Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial
Meletios A Dimopoulos, Ivan Spicka, Hang Quach, Albert Oriol, Roman Hajek, Mamta Garg, Meral Beksac, Sara Bringhen, Eirini Katodritou, Wee-Joo Chng, Xavier Leleu, Shinsuke Iida, Maria-Victoria Mateos, Gareth Morgan, Alexander Vorog, Richard Labotka, Bingxia Wang, Antonio Palumbo, Sagar Lonial
Journal of Clinical Oncology | AMER SOC CLINICAL ONCOLOGY | Published : 2020
PURPOSE: Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed. PATIENTS AND METHODS: The phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as main..View full abstract
Sponsored by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.