Celgene Corporation announced today that data evaluating clinical results on Revlimid (lenalidomide) as a new therapeutic approach for patients with newly diagnosed multiple myeloma (MM) was presented at the American Society of Hematology 46th Annual Meeting in San Diego.
Multiple myeloma is the second most common blood cancer in the United States affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 10,800 Americans (5,500 men and 5,300 women) are expected to die of multiple myeloma in 2004.
This Phase II trial was led by Vincent Rajkumar, M.D., a Mayo Clinic hematologist and oncologist. Dr. Rajkumar presented the initial results of this first Phase II trial using the combination of Revlimid plus dexamethasone with low dose (81 mg) aspirin as initial therapy for newly diagnosed MM. The median age was 64 years (range, 32-78). Twenty five of 30 patients achieved an objective response yielding a response rate of 83%. Ten patients (33%) have experienced grade 3 non-hematologic adverse events. These include one episode each of CD4-count < 200/mm3, anemia, neutropenia, increased liver enzymes, muscle weakness, agitation, hyperglycemia, cardiac arrhythmia, pneumonitis, erlichiosis, and colonic perforation. Notably, no deep vein thrombosis and no grade 4 or higher adverse events have been observed so far.
"These Phase II results suggest that oral combination therapy lenalidomide and dexamethasone (Rev/Dex) offer clinical benefit and is well tolerated in the treatment of newly diagnosed MM," explained Dr. Rajkumar. "A large randomized trial using Revlimid/Dexamethasone has recently started and is being conducted by the Eastern Cooperative Oncology Group."
The trial was designed to accrue 34 eligible patients; the first 30 consecutive patients (19 male and 11 female) were analyzed in this interim report. Patients were enrolled between February 2004 and July 2004. Revlimid was given orally at a dose of 25 mg daily on days 1-21 of a 28-day cycle. Dexamethasone was given orally at a dose of 40 mg daily on days 1-4, 9-12, 17-20 of each cycle. Patients also received an aspirin once daily as thrombosis prophylaxis. Response was defined as a decrease in serum monoclonal (M) protein by 50% or higher and a decrease in urine M protein by at least 90% or to a level less than 200 mg/24 hours, and needed to be confirmed by two readings at least 4 weeks apart. Responses were assessed on an intent-to-treat basis.