Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
- To study the toxicity of reduced intensity conditioning comprising fludarabine
phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic
stem cell transplantation in patients with refractory or relapsed multiple myeloma.
- To study the tumor response in these patients.
- To study the incidence of acute or chronic graft-versus-host disease in these patients.
- To study the incidence of infectious complications in these patients.
- To study relapse- or progression-free and overall survival of these patients.
- To study the biological mechanisms (i.e., taking graft, immunological recovery,
antitumor activity, and chimerism).
OUTLINE: This is a multicenter study.
Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1,
oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients
undergo allogeneic hematopoietic stem cell transplantation on day 0.
After completion of study therapy, patients are followed every month for 6 months and then
every 3 months for 1½ years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Mortality rate at 1 year
Didier Blaise, MD
United States: Federal Government