Study results comparing REVLIMID regimen to stem cell transplant in multiple myeloma patients

Dec 8 2009

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 REVLIMID (lenalidomide), melphalan and prednisone (MPR) or melphalan plus autologous stem cell transplant (MEL200) following an induction treatment of REVLIMID plus low-dose dexamethasone (Rd) were presented during the 51^st American Society of Hematology’s annual meeting in New Orleans, LA.

Autologous stem cell transplants have been a standard of myeloma treatment, particularly in younger patients. The aim of this study was to assess the clinical potential of an all-oral combination regimen, including REVLIMID, versus a transplant-based regimen.

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

After the Rd induction phase, 84% of patients achieved at least a partial response (PR) and 41% achieved at least a very good partial response (VGPR). Patients were then randomised and those who then received 3 cycles of MPR>

At a median follow-up of 12 months, the primary endpoint, 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 neutropaenia (46% and 86% for MPR and MEL200, respectively) and thrombocytopaenia (MPR 9%, MEL200 87%), infection (MPR 1%, MEL200 15%) and gastrointestinal events (MPR 1%, MEL200 23%).

REVLIMID is not approved as a treatment for patients newly diagnosed with multiple myeloma.