S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002849|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: recombinant interferon alfa Drug: dexamethasone||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis|
|Study Start Date :||November 1996|
|Actual Primary Completion Date :||December 1998|
|Actual Study Completion Date :||July 2000|
Experimental: induction and maintenance
dexamethasone induction followed by alpha interferon maintenance
Biological: recombinant interferon alfa
first 2 years
Other Name: alpha interferonDrug: dexamethasone
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
Other Name: decadron
- response [ Time Frame: 10 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002849
Show 40 Study Locations
|Study Chair:||Laura F. Hutchins, MD||University of Arkansas|
|Study Chair:||Richard A. Larson, MD||University of Chicago|