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Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis


- 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

- 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

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


- 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

- No senile, secondary, localized, dialysis-related, or familial amyloidosis

- No known therapy-related myelodysplasia



- Adult

Performance status:

- SWOG 0-4


- Not specified


- Not specified


- Not specified


- No NYHA class IV status


- 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


Biologic therapy

- No prior interferon alfa


- 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


- Not specified


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


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:


Principal Investigator

Laura F. Hutchins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arkansas


United States: Federal Government

Study ID:




Start Date:

November 1996

Completion Date:

July 2000

Related Keywords:

  • Multiple Myeloma
  • primary systemic amyloidosis
  • Amyloidosis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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