Multiple Myeloma Clinical Trial
S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 37 Locations for this study
La Jolla California, 92093, United States
San Francisco California, 94121, United States
Wilmington Delaware, 19899, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20307, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Worcester Massachusetts, 01655, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Buffalo New York, 14215, United States
Buffalo New York, 14263, United States
Manhasset New York, 11030, United States
Manhasset New York, 11030, United States
New York New York, 10021, United States
New York New York, 10021, United States
New York New York, 10029, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Syracuse New York, 13217, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Providence Rhode Island, 02906, United States
Burlington Vermont, 05401, United States
White River Junction Vermont, 05009, United States
Richmond Virginia, 23298, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.