Phase II Study of CC-5013 (Lenalidomide , Revlimid(tm)) and rituximab in Waldenstrom's macroglobulinemia

Status: COMPLETED
Date: 2/2/2005
Sponsor: Celgene Corporation
Institution: Dana Farber Cancer Institute
Physician: Dr. Steven Treon

As a follow up to our clinical trial combining Thalidomide with Rituxan therapy for WM, we have opened a clinical trial combining rituximab with CC-5013 to treat Rituximab and CC-5013 naïve WM patients who are symptomatic and in need of treatment. CC-5013 has been shown to be better tolerated in patients with related plasma cell malignancies, and in combination with rituximab, it demonstrates higher rituximab mediated tumor death in WM cells, versus Thalidomide. Patients on this study are treated with 48 weeks of CC-5013 at a dose of 15 mg qd, in combination with rituximab given over an 8 week infusion schedule. As part of our study objectives, we will seek to define objective response (ORR, CR, PR, MR), time to treatment failure, and toxicity for combined Rituximab and CC-5013 in Waldenstrom’s macroglobulinemia patients; and to identify the mechanism(s) of action for combined Rituximab and CC-5013 activity. This trial is only open for enrollment at the Dana-Farber Cancer Institute. For more information regarding this trial please contact Kirsten Meid at This email address is being protected from spambots. You need JavaScript enabled to view it.