Status:
COMPLETED
Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Celgene Corporation
Conditions:
Waldenstrom Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.
Detailed Description
Waldenstrom Macroglobulinemia (lymphoplasmacytic lymphoma, WM) is a low-grade lymphoplasmacytic lymphoma characterized by the involvement of the bone marrow with lymphoplasmacytic cells and the produc...
Eligibility Criteria
Inclusion
- The most important criteria for patient eligibility include:
- Age \>=18 years
- Patients must have received prior therapy (any number of therapies) for WM and have relapsed or refractory WM
- Eastern Cooperative Oncology Group performance score of 0 - 2
- Hemoglobin \>= 10g/dL or hematocrit \>= 30%
- Absolute neutrophil count (ANC) \>1000/mm3 and platelet count \>75,000/mm3
- 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
- Evaluable immunochemical abnormalities including abnormal electrophoresis and serum free light chain assay with an increase of either kappa or lambda light chain lev -
Exclusion
- Key Exclusion criteria
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
- Patients treated or requiring corticosteroids \>30mg/day
- Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide)
- Use of any other experimental drug or therapy within 28 days of baseline
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Known positive for HIV or infectious hepatitis, type A, B or C -
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02302469
Start Date
March 1 2009
End Date
April 1 2017
Last Update
November 28 2025
Active Locations (7)
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1
Centre Hospitalier de la côte basque
Bayonne, France, 64109
2
Ch Clermond Ferrand
Clermont-Ferrand, France, 63000
3
CH LENS
Lens, France, 62307
4
Chru Lille
Lille, France, 59037