Multiple Myeloma
Conditions
Keywords
primary systemic amyloidosis
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALrecombinant interferon alfa
first 2 years
DRUGdexamethasone
40 mg\*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles\*
Sponsors
National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically diagnosed primary systemic amyloidosis based on the following: * Deposition of fibrillary protein with Congo red positive stain or characteristic electron microscopic appearance * Monoclonal light chain protein (Bence-Jones protein) in serum or urine or immunohistochemical studies * Evidence of tissue involvement other than carpal tunnel syndrome * Diagnostic histologic material available for central pathology review * Confirmation of tissue diagnosis at all sites of organ dysfunction encouraged * No senile, secondary, localized, dialysis-related, or familial amyloidosis * No known therapy-related myelodysplasia PATIENT CHARACTERISTICS: Age: * Adult Performance status: * SWOG 0-4 Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No NYHA class IV status Other: * No uncontrolled diabetes * No active peptic ulcer disease * No medical condition that precludes high-dose steroids * No second malignancy within 5 years except: * Adequately treated nonmelanomatous skin cancer * In situ cervical cancer * Adequately treated stage I/II cancer in complete remission * Not pregnant or nursing * Effective contraception required of fertile patients * Blood/body fluid analyses within 14 days prior to registration * Imaging/exams for tumor measurement within 28 days prior to registration * Other screening exams within 42 days prior to registration PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interferon alfa Chemotherapy * Prior melphalan allowed, but recovered from effects * At least 4 weeks since cytotoxic therapy and recovered Endocrine therapy * Prior prednisone allowed, but recovered from effects * At least 4 weeks since prior glucocorticoids * No prior dexamethasone * No planned or concurrent dexamethasone or other therapy for primary systemic amyloidosis Radiotherapy * Not specified Surgery * Not specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response | 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). |
Countries
United States
Outcome results
None listed