SWOG clinical trial number
S9628

Phase II Study of Dexamethasone/Alpha Interferon In AL Amyloidosis

Closed
Phase
Accrual
93%
Published
Abbreviated Title
AL Amyloidosis
Activated
11/01/1996
Closed
03/15/2003
Participants
NCORP, Members, Pathologists, CALGB

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.

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

MV Dhodapkar;MA Hussein;E Rasmussen;A Solomon;RA Larson;JJ Crowley;B Barlogie Blood 104(12):3520-3526

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.

M Dhodapkar;J Jacobson;M Hussein;RA Larson;J Crowley;A Solomon;B Barlogie Proc of the American Society of Clinical Oncology 22:566(#2278)