Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma — NEJM
Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma
María-Victoria Mateos, M.D., Ph.D., Miguel-Teodoro Hernández, M.D., Pilar Giraldo, M.D., Javier de la Rubia, M.D., Felipe de Arriba, M.D., Ph.D., Lucía López Corral, M.D., Ph.D., Laura Rosiñol, M.D., Ph.D., Bruno Paiva, Ph.D., Luis Palomera, M.D., Ph.D., Joan Bargay, M.D., Albert Oriol, M.D., Felipe Prosper, M.D., Ph.D., Javier López, M.D., Ph.D., Eduardo Olavarría, M.D., Ph.D., Nuria Quintana, M.D., José-Luis García, M.D., Joan Bladé, M.D., Ph.D., Juan-José Lahuerta, M.D., Ph.D., and Jesús-F. San Miguel, M.D., Ph.D.
N Engl J Med 2013; 369:438-447August 1, 2013DOI: 10.1056/NEJMoa1300439 - Abstract
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Background
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.
Methods
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.
Results
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="" 0.10="" 0.31="" 0.91="" 2="" 3-year="" 79="" 80="" 90="" 95="" a="" achieved="" after="" also="" and="" better="" ci="" death="" during="" effects="" for="" grade="" group="" hazard="" higher="" in="" induction="" lower.="" mainly="" maintenance="" of="" or="" p="" partial="" patients="" phase.="" phase="" rate="" ratio="" response="" survival="" the="" to="" toxic="" treatment="" vs.="" was="" were="">
Conclusions
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.)
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