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

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Celgene Corporation; Genentech, Inc.
• Treatments: Lenalidomide; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria

• Age 18 years or older

• CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis

• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study

• Measurable disease, defined as presence of immunoglobulin M paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal.

• ECOG performance status of 0-2

• Absolute neutrophil count ≥ 100,000,000/L

• Platelet count ≥ 50,000,000,000/L

• Hemoglobin > 8 g/dL

• Serum creatinine < 2.5 mg/dL

• Total bilirubin < 1.5 mg/dL

• AST and ALT < 2.5 x ULN

• Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness

• Pregnant or lactating women

• Prior therapy with rituximab or CC-5103

• Known hypersensitivity to thalidomide

• Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

• Concurrent use of other anti-cancer agents or treatments