NCT00017680

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

Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days. Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and continuing until blood counts recover. This course may be repeated 4-12 weeks later. Patients are followed every 3 months for 1 year and then annually for 5 years.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	Melphalan	100 mg/m2 twice a day from Days -2 and -1 as induction therapy
PROCEDURE	Autologous Stem Cell Transplantation	Bone marrow and peripheral blood stem cells harvested

Timeline

• Start date: 1999-07-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2001-06-06
• Last updated: 2008-06-09

Locations

1 site across 1 country: United States