SWOG clinical trial number
S9805
Phase II Study of Tandem High Dose Melphalan Supported, by Peripheral Blood Stem Cell Support in Waldenstrom’s Macroglobulinemia (WM).
Closed
Phase
Accrual
18%
Treatment
Cyclophosphamide
Dexamethasone
Filgrastim
Intron A
Melphalan
Mesna
Eligibility Criteria Expand/Collapse
Patients must have diagnosis of WM based on demonstration of IgM monoclonal gammopathy with monoclonal light chain components in serum and/or urine, presence of monoclonal lymphocytic infiltration in BM, lymph nodes, spleen and/or liver. Those with large cell component with marked IgM serum levels >1 g/dl are also eligible. Patients must have quantifiable IgM; patients must have either clinical symptoms of WM, advanced tumor mass, or progressive disease (with specific requirements listed in the protocol). Patients must have PS of 0-2 and be < 70 years of age; prior chemo. and/or RT is allowed if 4 weeks have elapsed since ending treatment; patients must not have recent (< 6 months) MI, CHF or arrhythmia refractory to therapy; patients must have adequate pulmonary function and be negative for hepatitis B and HIV.