Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic
amyloidosis.
PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in
treating patients who have primary systemic amyloidosis.
OBJECTIVES:
- Evaluate M protein and organ dysfunction responses and overall and progression-free
survival in patients with primary systemic amyloidosis treated with
dexamethasone/interferon alfa.
- Identify prognostic factors that may relate to response and overall survival in these
patients.
- Evaluate the qualitative and quantitative toxic effects of this regimen.
OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no).
All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20
every 35 days for a total of 3 courses.
Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell
harvest) of initiation of the third course of induction, as follows: oral dexamethasone for
4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who
achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who
experienced less than grade 3 toxicity during induction receive 3 additional courses of
pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of
interferon alfa.
Combination therapy is continued until 2 years from entry; thereafter, interferon is
administered alone for at least 3 years, toxicity permitting. Patients with stable disease
after 5 years of therapy may discontinue interferon alfa at the discretion of the treating
physician.
Patients are followed every 6 months for 2 years and yearly thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or
iododoxorubicin treatment and 50 without) will be entered over 3 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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