Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •Disease Characteristics
• •Histologically confirmed primary amyloidosis
• •Ineligible for other high priority national or international study
• •Prior/Concurrent Therapy
• •Biologic therapy: Concurrent participation in gene therapy trials allowed
• •Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy
• •Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes)
• •Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed
• •Patient Characteristics
• •Performance status: ECOG 0-3
• •Hepatic: Bilirubin less than 2 times normal
• •Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis
• •Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist
• •Other: HIV negative