CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia

Phase 2 Terminated 16 enrolled Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center · collab Brigham and Women's Hospital · collab Celgene Corporation · collab Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the number of patients with Waldenstrom's macroglobulinemia that will benefit from treatment with CC-5103 (lenalidomide) and rituximab, what the side effects are and how long the benefit will last.

Timeline

Start: 2004-09
Primary completion: 2006-05
Completion: 2008-04

Outcome

Outcome not reported

Stopped: “Toxicity”

Publications

Results Treon SP, Soumerai JD, Branagan AR, Hunter ZR, Patterson CJ, Ioakimidis L, Chu L, Musto P, Baron AD, Nunnink JC, Kash JJ, Terjanian TO, Hyman PM, Nawfel EL, Sharon DJ, Munshi NC, Anderson KC. Lenalidomide and rituximab in Waldenstrom's macroglobulinemia. Clin Cancer Res. 2009 Jan 1;15(1):355-60. doi: 10.1158/1078-0432.CCR-08-0862.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CC-5103	Unknown	25 mg	Oral
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous