Revlimid study for Smoldering Multiple Myeloma

Celgene International announced that data evaluating treatment with Revlimid (lenalidomide) in combination with dexamethasone followed by Revlimid maintenance therapy in patients with high-risk asymptomatic Smoldering Multiple Myeloma were published in the August 1 edition of The New England Journal of Medicine.

Smoldering Multiple Myeloma is an early, asymptomatic form of the disease characterized by a 10% per year risk of progression to symptomatic disease over the first five years.

The Phase III, randomized, multicenter, open-label study, led by Maria-Victoria Mateos, M.D., Ph.D. from the Hospital Universitario de Salamanca on behalf of the Grupo Espanol de Mieloma (PETHEMA/GEM) evaluated whether treatment with the combination of lenalidomide and dexamethasone followed by lenalidomide maintenance in high-risk asymptomatic Smoldering Multiple Myeloma patients prolonged time to progression to symptomatic disease compared with patients who did not receive active treatment and were just observed, which is the current standard of care for Smoldering Multiple Myeloma.

After a median follow-up of 40 months, median time to progression to symptomatic disease, the primary endpoint of the study, was significantly longer in the treatment group compared with the observation group (not reached vs. 21 months; HR=0.18; p<0.001). the three-year overall survival rate from study inclusion was also higher in the treatment group compared with the observation group 94 vs. 80 hr="0.31;" p="0.03)." a partial response was seen in 79 of the patients in the treatment group during induction and 90 during the maintenance phase.>

see "Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma"=Mar�a-Victoria Mateos, M.D., Ph.D., Miguel-Teodoro Hern�ndez, M.D., Pilar Giraldo, M.D., et al N Engl J Med 2013; 369:438-447August 1, 2013DOI: 10.1056/NEJMoa1300439