A Phase II Trial of Tandem Transplantation in AL Amyloidosis
- Determine the tolerability of tandem autologous stem cell transplantation in patients
with AL amyloidosis.
- Determine whether this regimen can convert a hematologic non-complete response (CR) to
CR in these patients.
- Determine the overall survival of patients treated with this regimen.
- First transplantation: Patients receive filgrastim (G-CSF) subcutaneously once daily
beginning 3 days before the initiation of stem cell collection and continuing until the
day before the completion of stem cell collection. Patients may undergo bone marrow
harvest if an inadequate number of peripheral blood stem cells are collected.
Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. Patients undergo
autologous stem cell transplantation (ASCT) on day 0.
- Second transplantation: Within 6-12 months after the first ASCT, patients not achieving
a complete response receive high-dose melphalan IV over 20 minutes on days -3 and -2
and a second ASCT on day 0.
Treatment continues in the absence of unacceptable toxicity.
Patients are followed at 3 and 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 2-3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
100 days, 6 months, and annual
Vaishali Sanchorawala, MD
Boston Medical Center
United States: Federal Government
|Cancer Research Center at Boston Medical Center||Boston, Massachusetts 02118|