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

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation.

II. Determine the toxicity of this regimen in these patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Irving Comprehensive Cancer Center
• Treatments: Melphalan

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