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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

93

Study ID:

NCT00002849

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 37 Locations for this study

See Locations Near You

Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Veterans Affairs Medical Center - San Francisco
San Francisco California, 94121, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri, 65203, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York, 14215, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
CCOP - North Shore University Hospital
Manhasset New York, 11030, United States
North Shore University Hospital
Manhasset New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Weill Medical College of Cornell University
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Durham
Durham North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
Lifespan: The Miriam Hospital
Providence Rhode Island, 02906, United States
Vermont Cancer Center
Burlington Vermont, 05401, United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont, 05009, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

93

Study ID:

NCT00002849

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider