Indefinite-Duration Maintenance Therapy No Better Than Fixed-Duration Therapy in Multiple Myeloma

THURSDAY, July 23, 2026 (HealthDay News) — For patients with standard-risk newly diagnosed multiple myeloma not undergoing up-front autologous stem cell transplantation, indefinite-duration maintenance therapy does not yield significantly longer overall survival compared with fixed-duration maintenance therapy, according to a study published in the July 16 issue of the New England Journal of Medicine.

Shaji Kumar, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a phase 3 trial enrolling patients with standard-risk newly diagnosed multiple myeloma who were not undergoing up-front autologous stem cell transplantation. After proteasome inhibitor-lenalidomide combination induction treatment, patients were randomly assigned to receive indefinite-duration lenalidomide (continuous) or fixed-duration lenalidomide (two years; 260 and 256 patients, respectively).

The researchers found that overall survival did not differ between the groups at a median follow-up of 86 months. At seven years, overall survival was 68.6 and 69.0 percent in the indefinite-duration and fixed-duration groups, respectively (80 deaths in each group). At seven years, progression-free survival was 36.1 and 29.7 percent in the indefinite-duration and fixed-duration groups, respectively. The five-year cumulative incidence of second primary cancers was 11.2 and 8.3 percent with indefinite-duration and fixed-duration lenalidomide, respectively. There were more adverse events with indefinite-duration lenalidomide: The incidence rate of nonhematologic events of grade 3 or higher was 48.2 versus 31.5 percent with indefinite-duration versus fixed-duration therapy.

“This study reminds us that clinical trials shouldn”t only focus on adding new therapies,” Kumar said in a statement. “They should also help us understand when treatment can safely stop.”

Several authors disclosed ties to biopharmaceutical companies, including Amgen, which partially funded the study.

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