NCT00002849

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa	first 2 years
DRUG	dexamethasone	40 mg\*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles\*

Timeline

• Start date: 1996-11-01
• Primary completion: 1998-12-01
• Completion: 2000-07-01
• First posted: 2003-01-27
• Last updated: 2015-03-06

Locations

40 sites across 1 country: United States