Ixazomib Plus Lenalidomide/Dexamethasone for Transplant-Ineligible Patients With Myeloma
Posted: Monday, November 16, 2020
The addition of ixazomib to lenalidomide/dexamethasone for patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation led to clinically meaningful outcomes, based on results from the phase III TOURMALINE-MM2 trial. This study was presented by Thierry Facon, MD, of the University of Lille, France, at the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting on behalf of his colleagues (Abstract MM-347).
“Ixazomib/lenalidomide/dexamethasone is a feasible treatment option for certain transplant-ineligible patients with newly diagnosed multiple myeloma who could benefit from an all-oral triplet combination,” concluded the authors.
This multicenter, double-blind study recruited 705 patients with transplant-ineligible newly diagnosed multiple myeloma. Patients were recruited from 157 sites across 8 countries. Patients were randomly assigned to receive either 25 mg of lenalidomide and 40 mg of dexamethasone plus placebo or 25 mg of lenalidomide and 40 mg of dexamethasone plus 4 mg of ixazomib. Subsequently, the dexamethasone was stopped, and the lenalidomide dosing was decreased to 10 mg, and ixazomib was decreased to 3 mg.
At the time of data cutoff, the median progression-free survival was 35.3 months among patients receiving the triplet therapy and 21.8 months among patients receiving the doublet. This benefit was particularly noticeable among patients with stage III disease, those younger than age 75, and patients with a creatinine clearance of less than 60 mL/min. Those with high-risk cytogenetic abnormalities who received the triplet had a progression-free survival of 23.8 months, compared with 18.0 months with ixazomib and placebo. The complete response rate was 25.6% with the triplet and 14.1% with the doublet (P < .001).
All patients enrolled in the study experienced a treatment-emergent adverse event of any grade, whereas 88.1% and 81.4% of patients receiving ixazomib and placebo experienced grade 3 or higher adverse events. The most common adverse events included diarrhea, rash, peripheral edema, constipation, and nausea.
Disclosure: Disclosure information for the study authors was not provided.