In a phase 3 trial, researchers evaluated the optimal duration of lenalidomide maintenance therapy in patients with newly diagnosed multiple myeloma and found that indefinite-duration treatment did not significantly improve overall survival compared to a fixed two-year duration.
The study was led by Shaji Kumar, MD, of the Mayo Clinic in Rochester, Minnesota, and published in The New England Journal of Medicine.
The trial enrolled patients with standard-risk disease who were not undergoing up-front autologous stem-cell transplantation. Following induction treatment with a proteasome inhibitor–lenalidomide combination, a total of 516 patients underwent randomization at the end of induction.
Investigators randomly assigned 260 patients to receive indefinite-duration (continuous) lenalidomide and 256 patients to receive fixed-duration lenalidomide for two years.
At a median follow-up of 86 months, overall survival did not differ significantly between the treatment groups, with 80 deaths occurring in each group.
The overall survival rate at seven years was 68.6% in the indefinite-duration group and 69.0% in the fixed-duration group. Progression-free survival at seven years was 36.1% with continuous therapy and 29.7% with fixed-duration therapy.
More adverse events occurred with indefinite-duration lenalidomide. The incidence of non-hematologic adverse events of grade 3 or higher was 48.2% in the indefinite-duration group compared to 31.5% in the fixed-duration group.
Additionally, the five-year cumulative incidence of second primary cancers, excluding nonmelanoma skin cancer, was 11.2% with indefinite-duration lenalidomide and 8.3% with fixed-duration lenalidomide.
The study was funded by the National Cancer Institute and Amgen.
Reference
Kumar S, Jacobus S, Cohen A, et al. Continuous or fixed-duration maintenance therapy in multiple myeloma. N Engl J Med. 2026;395(3):221-232. doi:10.1056/NEJMoa2600157
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