This phase 3 RCT (ENDURANCE) compared indefinite (continuous) vs. fixed 2-year lenalidomide maintenance in 516 patients with standard-risk newly diagnosed multiple myeloma who did not undergo up-front autologous stem-cell transplantation, after induction with a proteasome inhibitor–lenalidomide combination; median follow-up was 86 months.
Overall survival at 7 years was nearly identical: 68.6% (continuous) vs. 69.0% (fixed-duration; difference −0.4 pp; 95% CI −9.0 to 8.3; P=0.93), with 80 deaths in each group. Progression-free survival at 7 years favored continuous therapy but was not significant (36.1% vs. 29.7%; difference 6.4 pp; 95% CI −2.6 to 15.4). Grade ≥3 nonhematologic adverse events were substantially higher with continuous lenalidomide (48.2% vs. 31.5%), and 5-year second primary cancer incidence was higher (11.2% vs. 8.3%).
- Trial enrolled only standard-risk, non-transplant patients, limiting generalizability to high-risk or transplant-eligible populations. - The study was powered to detect a large survival difference (50% increase in median OS); smaller but clinically meaningful differences may have been missed. - Full-text page content was not available for detailed subgroup analysis review.
For standard-risk, non-transplant myeloma patients, 2 years of lenalidomide maintenance appears to provide equivalent overall survival to indefinite therapy, with meaningfully fewer serious adverse events and a lower second-cancer burden. Clinicians may reasonably offer fixed-duration maintenance as a standard option, sparing patients prolonged toxicity without sacrificing survival.
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