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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompletedadultNCI, OtherS9628
CLB-9790, CLB-S9628, U10CA032102, SWOG-S9628, SWOG-9628, NCT00002849

Trial Description


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.

Further Study Information


  • 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.

Eligibility 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 encouraged
  • 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 amyloidosis


  • Not specified


  • Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

  • National Cancer Institute
  • Cancer and Leukemia Group B
Laura Fulper Hutchins, Study Chair
Richard A. Larson, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00002849
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.