03163nam a2200277   4500001000800000005001700008007000300025008004100028040000800069041000800077100003200085245007300117300002300190520230000213650002002513650001902533650003902552700002802591700002302619700002802642700003102670700002602701773011002727942003102837999001702868ESSALUD20260804154305.0ta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aKumar, Shaji eAutor953732  aContinuous or fixed-duration maintenance therapy in multiple myeloma  apáginas: 221-232  aBackground: Current treatment of newly diagnosed multiple myeloma involves lenalidomide maintenance therapy given until disease progression. The appropriate duration of maintenance therapy with lenalidomide has been unclear. Methods: In this phase 3 trial, we enrolled patients with standard-risk newly diagnosed multiple myeloma who were not undergoing up-front autologous stem-cell transplantation. After induction treatment with a proteasome inhibitor–lenalidomide combination, patients were randomly assigned to receive indefinite-duration (continuous) lenalidomide or fixed-duration lenalidomide (for 2 years). The primary end point was overall survival; the trial had 80% power to detect a 50% increase in median survival (from 5 years to 7.5 years), with a two-sided alpha level of 5%, 395 patients undergoing randomization, and 204 deaths occurring during 9 years of follow-up.
Results: At the end of induction, 516 patients were randomly assigned to the indefinite-duration group (260 patients) or the fixed-duration group (256 patients). At a median follow-up of 86 months, overall survival did not differ significantly between the groups. With 80 deaths in each group, overall survival at 7 years was 68.6% in the indefinite-duration group and 69.0% in the fixed-duration group (difference, −0.4 percentage points; 95 confidence interval [CI], −9.0 to 8.3; P=0.93). Progression-free survival at 7 years was 36.1% in the indefinite-duration group and 29.7% in the fixed-duration group (difference, 6.4 percentage points; 95% CI, −2.6 to 15.4). The 5-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. More adverse events occurred with indefinite-duration lenalidomide; the incidence of nonhematologic events of grade 3 or higher was 48.2% with indefinite-duration therapy and 31.5% with fixed-duration therapy.
Conclusions: In this phase 3 trial involving patients with standard-risk newly diagnosed multiple myeloma who were not undergoing up-front autologous stem-cell transplantation, indefinite-duration maintenance therapy after induction therapy did not result in significantly longer overall survival than fixed-duration maintenance therapy.   aLEUCEMIA933873  aLIMFOMA953733  aTRATAMIENTOS EN ONCOLOGÍA953734  aJacobus, Susanna953735  aCohen, Adam953736  aWeiss, Matthias 953737  aCallander, Natalie 953738  aSingh, Avina  9537390 022717922636dMassachusetts NEJM GroupoNEJM003tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-07-31zSQB  c22736d22736