Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in
different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as
cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma
cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide
together with cyclophosphamide and dexamethasone may be an effective treatment for primary
systemic amyloidosis.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with
cyclophosphamide and dexamethasone works in treating patients with primary systemic
amyloidosis.
OBJECTIVES:
Primary
* Assess the hematologic response rate in patients with primary systemic amyloidosis treated
with lenalidomide, cyclophosphamide, and dexamethasone.
Secondary
- Determine the organ response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide* on days 1,
8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
NOTE: *Patients may receive cyclophosphamide for up to 1 year. After completion of study
treatment, patients are followed every 6 months for up to 3 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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