Phase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL Amyloidosis
- To determine if hematologic responses to high-dose melphalan and autologous stem cell
transplantation increase with addition of bortezomib in the conditioning regimen in
patients with primary systemic amyloidosis.
- Autologous stem cell mobilization and collection: Patients receive filgrastim (G-CSF)
to mobilize stem cells, which are then collected.
- Conditioning regimen: Patients receive bortezomib IV on days -6, -3, 1, and 4 and oral
high-dose melphalan on days -2 and -1.
- Stem cell transplantation: Patients undergo autologous stem cell transplantation on day
After completion of study therapy, patients are followed every 6 months for 1 year and
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematologic response (complete and partial)
Vaishali Sanchorawala, MD
Boston Medical Center
United States: Food and Drug Administration
|Boston University Cancer Research Center||Boston, Massachusetts 02118|