Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)
- Assess overall and progression-free survival following high-dose melphalan and
autologous peripheral blood stem cell transplantation in patients with primary
- Evaluate the toxic effects associated with this treatment regimen.
- Evaluate the function of involved organs, especially the heart, lungs, and nervous
system, before and after treatment with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte
colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients
receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC
transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count
is greater than 1,500 for 3 consecutive days.
Patients are followed at 100 days and 1 year post-transplant.
PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Kenneth F. Mangan, MD, FACP
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase-Temple Cancer Center CCOP Research Base||Philadelphia, Pennsylvania 19111-2442|