CompletedPhase 1/2

Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia

France17 participantsStarted 2009-03

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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 -

Number of Participants with dose limiting toxicities (DLT) of lenalidomide as a Measure of Safety and Tolerability.

Timeframe: 1 month

NCT IDNCT02302469

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03