Leukemia Clinical Trial
Official title:
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
This open-label trial will evaluate a dose of oral lenalidomide 10 mg taken daily on days 1-21 of 28 day cycle. Oral melphalan 0.18mg/kg will be taken on days 1-4 of a 28 day cycle. Oral dexamethasone 40 mg will be taken on days 1, 8, 15 and 22 of a 28 day cycle. Up to 15 patients over the age of 18 with newly diagnosed or relapsed AL amyloidosis will be included in this study. In the absence of disease progression or toxicity, patients will complete nine cycles of therapy. After nine cycles, subjects have the option of continuing lenalidomide therapy alone. The primary objective of this study is safety and tolerability of the above regimen. The secondary objectives are hematologic and organ responses, as well as time to progression.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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