S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: dexamethasone

Biological: recombinant interferon alfa

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00002849

CLB-S9628 (Other Identifier)

CLB-9790 (Other Identifier)

S9628 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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