This Phase III trial was designed to compare the efficacy and safety of a combination of two oral drugs, lenalidomide and low-dose dexamethasone (Rd), to a standard combination therapy including melphalan, prednisone, and thalidomide (MPT) used worldwide to treat patients with newly diagnosed multiple myeloma (NDMM).

A total of 1,623 NDMM patients ineligible for stem cell transplant due to age or other factors were randomized into three treatment arms: continuous Rd until disease progression, Rd for 72 weeks, or MPT for 72 weeks.

After a median follow-up period of 37 months, the study met its primary endpoint by demonstrating that those patients treated with continuous Rd were more than a quarter (28%) less likely to experience disease progression or death than those patients treated with MPT.

Further, patients in both Rd treatment arms showed improvements in overall survival, overall response rate, and duration of response. While the safety profiles of the two treatment regimens were similar, patients treated with Rd showed fewer secondary hematologic malignancies than those treated with MPT.

“Traditionally, newly diagnosed patients have received initial, short bursts of treatment, while continuous treatment was reserved for relapsed patients. However, we believe that these new results will help encourage more research on the efficacy and safety of continuous treatment for newly diagnosed patients to help maximize their chances for overall long-term survival,” said study author Thierry Facon, MD, of Service des Maladies du Sang, Hôpital Claude Huriez, and CHRU Lille in France. “For some patients with low-risk myeloma, this continuous regimen could make this disease a manageable, chronic condition.”

Source: ASH