Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma

SUMMARY: REVLIMID® (Lenalidomide) is an immunomodulatory agent with significant activity in patients with Multiple Myeloma, by virtue of its multiple mechanism of action. In this randomized, double blind, multicenter study, patients 65 years or older with newly diagnosed multiple myeloma, ineligible for transplantation, were randomized and the comparison was MPR followed by R (melphalan, prednisone and REVLIMID® followed by REVLIMID® maintenance) vs MPR or MP followed by placebo. There was a statistically significant prolongation in the progression free survival with a 51% reduction in the risk of progression for those who received REVLIMID® maintenance (MPR followed by R) compared to those who received MPR followed by placebo. This benefit was predominantly observed in patients who were 65-75 years of age. The response rates were also higher in the MPR-R and MPR groups compared to the MP group. There was a slightly higher incidence of second primary malignancies in those exposed to REVLIMID® (MPR-R and MPR) compared to the MP group (7% vs 3%). This study has demonstrated the benefit of adding REVLIMID® for induction therapy as well as maintenance, in patients 65-75 years of age, ineligible for transplant. Palumbo A, Hajek R, Delforge M, et al. N Engl J Med 2012;366:1759-1769