Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

The most important criteria for patient eligibility include:

1. Age >=18 years

2. Patients must have received prior therapy (any number of therapies) for WM and have relapsed or refractory WM

3. Eastern Cooperative Oncology Group performance score of 0 - 2

4. Hemoglobin >= 10g/dL or hematocrit >= 30%

5. Absolute neutrophil count (ANC) >1000/mm3 and platelet count >75,000/mm3

6. Adequate organ function defined as

• serum glutamate pyruvate transaminase and serum glutamate oxaloacetate transaminase < 2 x International Unit/l

• Total bilirubin >= 1.5 mg/dL

• Clearance creatinin > 50 ml/mn

7. Evaluable immunochemical abnormalities including abnormal electrophoresis and serum free light chain assay with an increase of either kappa or lambda light chain lev -

Exclusion Criteria:

Key Exclusion criteria

1. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation

2. Patients treated or requiring corticosteroids >30mg/day

3. Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide)

4. Use of any other experimental drug or therapy within 28 days of baseline

5. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs

6. Known positive for HIV or infectious hepatitis, type A, B or C -