A Phase II Study of Intravenous Melphalan and Busulfan Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma
- Evaluate transplant-related mortality in patients with multiple myeloma treated with a
myeloablative conditioning regimen comprising melphalan and busulfan followed by
HLA-matched, allogeneic peripheral blood stem cell transplantation (PBSCT) and
graft-vs-host disease prophylaxis with tacrolimus and methotrexate.
- Determine the disease response in patients treated with this regimen.
- Determine the 1-year progression-free survival and overall survival in patients treated
with this regimen.
- Conditioning regimen: Patients receive melphalan IV over 30 minutes on day -6 and
busulfan IV over 3 hours on days -5 to -3.
- Peripheral blood stem cell transplantation (PBSCT): Patients undergo HLA-matched,
related donor, allogeneic PBSCT on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV
continuously or orally twice daily beginning on day -2 and continuing until day 80
followed by a taper until day 180 in the absence of GVHD or disease progression.
Patients also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Transplant-related mortality at 180 days
William I. Bensinger, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|