2026-09-16T19:37:06Zhttps://gredos.usal.es/oai/request

oai:gredos.usal.es:10366/1542982026-06-20T10:40:19Zcom_10366_4019com_10366_3947com_10366_3946com_10366_3823col_10366_4020

Mateos Manteca, María Victoria Hernández, Miguel-Teodoro Giraldo, Pilar De la Rubia, Javier De Arriba, Felipe López Corral, Lucía Rosiñol, Laura Paiva, Bruno Palomera, Luis Bargay, Joan Oriol, Albert Prósper, Felipe López, Javier Olavarría, Eduardo Quintana, Nuria García, José-Luis Bladé, Joan Lahuerta, Juan José San Miguel Izquierdo, Jesús Fernando Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Dexamethasone Disease Progression Female Follow-Up Studies Humans Induction Chemotherapy Lenalidomide Male Middle Aged Multiple Myeloma Risk Survival Rate Thalidomide [EN]For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. (Funded by Celgene; ClinicalTrials.gov number, NCT00480363.). 2024-01-16 2024-01-16 2013-08-01 info:eu-repo/semantics/article Mateos, M. V., Hernández, M. T., Giraldo, P., de la Rubia, J., de Arriba, F., Corral, L. L., ... & San Miguel, J. F. (2013). Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. New England Journal of Medicine, 369(5), 438-447. doi: 10.1056/NEJMoa1300439. PMID: 23902483. http://hdl.handle.net/10366/154298 10.1056/NEJMoa1300439 23902483 1533-4406 eng https://www.nejm.org/doi/full/10.1056/nejmoa1300439 http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Attribution-NonCommercial-NoDerivatives 4.0 Internacional NEJM Group