Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
- Conditions
- Amyloidosis
- Registration Number
- NCT00017680
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction
- Secondary Outcome Measures
Name Time Method Toxicity of high dose chemotherapy regimen
Trial Locations
- Locations (1)
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center🇺🇸New York, New York, United States