S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic 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.
|Multiple Myeloma||Biological: recombinant interferon alfa Drug: dexamethasone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis|
- response [ Time Frame: 10 months ]50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).
|Study Start Date:||November 1996|
|Study Completion Date:||July 2000|
|Primary Completion Date:||December 1998 (Final data collection date for primary outcome measure)|
Experimental: induction and maintenance
dexamethasone induction followed by alpha interferon maintenance
Biological: recombinant interferon alfa
first 2 years
Other Name: alpha interferonDrug: dexamethasone
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
Other Name: decadron
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002849
Show 40 Study Locations
|Study Chair:||Laura F. Hutchins, MD||University of Arkansas|
|Study Chair:||Richard A. Larson, MD||University of Chicago|