Revlimid combo could become MM standard of care

US drugmaker Celgene presented positive data from a Phase I/II study evaluating a combination of Revlimid (lenalidomide), melphalan and prednisone (R-MP) in elderly newly-diagnosed multiple myeloma patients at the 12th Congress of the European Hematology Association, held in Vienna, Austria. The updated data reported that, after two years, the overall survival rate was 91% (p<0.05) with an event-free survival rate of 75% (p<0.034). This also demonstrated that, after nine treatment cycles with R-MP, all patients showed a response with no further disease progressions observed.

"These results compare to autologous stem cell transplantation outcomes and could result in a change in the treatment strategy for elderly patients if confirmed by a Phase III study evaluating the Revlimid treatment combination versus transplantation," said Mario Boccadoro, director of hematology, University of Torino, Italy, while Torino professor of medicine Antonio Palumbo said that, if these Phase II data are confirmed by an ongoing Phase III trial due to release results in 2008, "the R-MP combination will become the standard-of-care in newly-diagnosed elderly patients."

In the Phase I/II multicenter, dose-escalating, open-label trial, 53 patients (median age 71) received at least one R-MP course. After nine cycles of therapy, a complete response was observed in 24% of patients, 24% showed a very good partial response, while a partial response was seen in 33% of patients. No dose-limiting toxicities were observed in the first two dose levels, Celgene noted.