ASH 2018: Ixazomib Maintenance After Transplantation in Newly Diagnosed Multiple Myeloma
Posted: Monday, December 10, 2018
The phase III Tourmaline-MM3 trial, conducted by Meletios A. Dimopoulos, MD, of the University Athens School of Medicine, Greece, and colleagues, indicated that maintenance therapy with the oral proteasome inhibitor ixazomib appears to be an effective option in responding patients with newly diagnosed multiple myeloma after autologous stem cell transplantation. The results, which showed a 28% reduction in the risk of disease progression or death, were presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 301) in San Diego.
“I think this has the potential to be a big practice-changer,” noted Robert Rifkin, MD, FACP, of Rocky Mountain Cancer Center, during a news briefing prior to the ASH Annual Meeting.
A total of 656 patients with newly diagnosed multiple myeloma were enrolled: 395 received ixazomib and 261, placebo. The study patients had at least a partial response to induction therapy with a proteasome inhibitor and/or immunomodulatory drug followed by single autologous stem cell transplantation.
With a median follow-up of 31 months, the researchers recorded a 28% reduction in the risk of disease progression or death, which corresponded to a 39% improvement in progression-free survival with ixazomib versus placebo (median 26.5 vs. 21.3 months). Patients who underwent ixazomib therapy experienced “deepening of responses and increased conversions to minimal residual disease negativity” compared with placebo
As for toxicity, grade ≥ 3 adverse events were more common with ibrutinib than placebo (42% vs. 26%). The most common grade ≥ side effects were infections (including pneumonia), gastrointestinal disorders, neutropenia, and thrombocytopenia. Peripheral neuropathy was reported in 19% of patients treated with ibrutinib and 15% of those treated with placebo, and the rate of secondary primary malignancies was 3% in both groups.