A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone,
in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
- To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once
daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 12 months in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed every 3 months until disease
progression and then annually thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematologic response rate as measured by standard criteria
measured by standard criteria
David C. Seldin, MD, PhD
Boston Medical Center
United States: Food and Drug Administration
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