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

Stopped early · Phase 2

Conditions studied: Waldenstrom's Macroglobulinemia

In brief

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.

Key facts

Study ID

NCT00142168

Run by

Dana-Farber Cancer Institute

People needed

16

Starts

2004-09-01

Expected to finish

2008-04-01

Last updated by the study team

2016-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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