Early treatment with Revlimid® (lenalidomide) and dexamethasone for patients with high-risk smoldering multiple myeloma delays progression to active disease and increases overall survival, according to the results of a study published in the New England Journal of Medicine.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.
The standard of care for smoldering multiple myeloma is observation until symptoms develop—however, this approach does nothing to help identify high-risk patients who may benefit from early intervention.
Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients.
Researchers conducted a randomized, open-label, phase 3 trial that included 119 patients with high-risk smoldering myeloma who were randomly assigned to treatment or observation. Patients in the treatment group received an induction regimen of Revlimid/dexamethasone for six months followed by a maintenance regimen of Revlimid for two years. The primary endpoint of the study was progression to symptomatic disease. Secondary endpoints 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—in fact, those in the observation group reached disease progression at a median of 21 months, while disease progression was not seen in the treatment group over the follow-up period. What’s more—the 3-year survival rate was significantly higher (94%) in the treatment group compared with the observation group (80%).
Among patients in the treatment group, 79 percent achieved a partial response or better after the induction phase and 90 percent achieved partial response or better during the maintenance phase.
The treatment was well-tolerated and adverse effects were mainly grade 2 or lower, although one patient had a grade 5 adverse event (respiratory infection).
The researchers concluded that early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival.
Mateos MV, Hernández MT, Giraldo P, et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. New England Journal of Medicine. 2013; 369: 438-447.
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