SWOG clinical trial number
S9628
Phase II Study of Dexamethasone/Alpha Interferon In AL Amyloidosis
Closed
Phase
Accrual
93%
Published
Research committees
Myeloma
Treatment
Dexamethasone
Alpha Interferon
Eligibility Criteria Expand/Collapse
Histologic diagnosis of primary systemic (AL) amyloidosis based on 1) deposition of fibrillary protein with Congo red positive stain or characteristic electron microscopic appearance, and 2) monoclonal light chain protein (Bence Jones Protein) in the serum or urine or immunohistochemical studies and 3) evidence of tissue involvement other than carpal tunnel syndrome. Patients with senile, secondary, localized, dialysis-related or familial amyloidosis are not eligible; PS 0 - 4; patients with a PS of 4 are eligible if it is solely due to autonomic or peripheral neuropathy: patients must not have received prior alpha interferon or
dexamethasone or be planning to receive dexamethasone or other concurrent therapy for AL amyloidosis. Patients with prior melphalan and prednisone therapy (except those with known therapy related myelodysplasia) are eligible; patients must have fully recovered from the effects of prior cytotoxic or glucocorticoids therapy; patients must not have uncontrolled diabetes, active peptic ulcer disease, NYHA class IV congestive heart failure, or another medical condition precluding use of high dose steroids. Specimens must be submitted for research studies.
dexamethasone or be planning to receive dexamethasone or other concurrent therapy for AL amyloidosis. Patients with prior melphalan and prednisone therapy (except those with known therapy related myelodysplasia) are eligible; patients must have fully recovered from the effects of prior cytotoxic or glucocorticoids therapy; patients must not have uncontrolled diabetes, active peptic ulcer disease, NYHA class IV congestive heart failure, or another medical condition precluding use of high dose steroids. Specimens must be submitted for research studies.
Publication Information Expand/Collapse
2004
Clinical efficacy of high dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup trial Southwest Oncology Group (SWOG) S9628
2003
High dose dexamethasone (Dex) with maintenance Dex/alpha interferon lead to improved survival in patients with primary systemic amyloidosis: results of US Intergroup Trial Southwest Oncology Group (SWOG) S9628.
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Research Committee(s)
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Phase
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Research Committee(s)
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Research Committee(s)
Myeloma
Activated
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Accrual
10%
Open
Phase