Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Phase II Study of Dexamethasone/Alpha-Interferon in AL 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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response
Outcome Description:
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).
Outcome Time Frame:
10 months
Safety Issue:
No
Principal Investigator
Laura F. Hutchins, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Arkansas
Authority:
United States: Federal Government
Study ID:
CDR0000065092
NCT ID:
NCT00002849
Start Date:
November 1996
Completion Date:
July 2000
Related Keywords:
- Multiple Myeloma
- primary systemic amyloidosis
- Amyloidosis
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
| Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
| Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| Weill Medical College of Cornell University | New York, New York 10021 |
| Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
