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Study Finds No Survival Benefit From Continuing Lenalidomide Maintenance Past Two Years

This result could prompt guidelines to favor a two‑year fixed maintenance schedule for many standard‑risk, non‑transplant myeloma patients.

Overview

  • A randomized phase 3 trial reported in the New England Journal of Medicine showed nearly identical overall survival for continuous lenalidomide versus stopping after two years in standard‑risk, newly diagnosed myeloma patients.
  • The trial randomized 516 patients and with seven years median follow‑up found overall survival of 69.0% for continuous therapy and 68.6% for two‑year therapy, showing no survival advantage for indefinite maintenance.
  • Continuous maintenance produced a modestly longer median progression‑free survival (42.5 vs 38.9 months) but caused more serious non‑hematologic toxicity and a higher five‑year incidence of second primary cancers.
  • Investigators, reporting their results in mid‑July 2026, say the findings support shared decision‑making and a fixed two‑year maintenance approach for the studied group and could reduce patient burden and drug spending.
  • The results apply only to standard‑risk patients who did not undergo autologous transplant, leaving questions about optimal duration for high‑risk disease and MRD‑guided strategies that future trials will address.