S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
- Conditions
- Multiple Myeloma
- Interventions
- Biological: recombinant interferon alfa
- Registration Number
- NCT00002849
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description induction and maintenance recombinant interferon alfa dexamethasone induction followed by alpha interferon maintenance induction and maintenance dexamethasone dexamethasone induction followed by alpha interferon maintenance
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States