Phase II Trial of Second Autologous Transplantation in AL Amyloidosis
- Determine the feasibility and tolerability of second autologous stem cell
transplantation in patients with persistent or recurrent AL amyloidosis.
- Determine the response rate and durability of response in patients treated with this
- Determine immune reconstitution in patients treated with this regimen.
- Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily
beginning before the initiation of stem cell collection and continuing until the day
before the completion of stem cell collection.
- Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3
- Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0.
Patients are followed at 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and tolerability
3 months after treatment and annually
Karen Quillen, MD
Boston Medical Center
United States: Food and Drug Administration
|Boston University Cancer Research Center||Boston, Massachusetts 02118|