Clinical data from investigational study of patients with multiple myeloma presented at ASCO

Jun 11 2010

Celgene International Sàrl (NASDAQ: CELG) announced clinical data from an investigational study of patients with multiple myeloma who were younger than 65 years old and received either lenalidomide (REVLIMID), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of lenalidomide plus low-dose dexamethasone (Rd) were presented at the American Society of Clinical Oncology annual meeting.

In the study, 402 patients received four 28-day cycles of Rd as an induction therapy. Patients were then randomized to receive either six 28-day courses of MPR or tandem autologous stem cell transplant (MEL200). Upon completion of this regimen, patients were randomized to either continuous lenalidomide or no continuous therapy until relapse.

Following the Rd induction phase, 86% (318/370) of patients achieved a partial response (PR) or better and 37% (137/370) achieved at least a very good partial response (VGPR). After randomization, 55% of those who received at least three cycles of MPR (64/117) achieved at least a VGPR, with 13% (15/117) achieving a complete response (CR). Fifty-three percent of patients who received the first of the tandem autologous stem cell transplant (MEL200) (65/122) achieved at least a VGPR, with 16% (20/122)>

Progression-free survival was the primary endpoint of the trial. At a median follow-up of 14 months the 1-year progression free survival rate was 91% for both the MPR and autologous stem cell transplant (MEL200) arms>

In the study, the most common grade 3 or 4 adverse events were neutropenia (Rd 9%, MPR 48%, MEL200 84%), thrombocytopenia (Rd 3%, MPR 8%, MEL200 84%), infection (Rd 5%, MPR 0%, MEL200 17%) and gastrointestinal events (MPR 0%, MEL200 22%).

These data are from an investigational study. REVLIMID is not approved as a treatment for patients newly diagnosed with multiple myeloma.