A Study of Outcomes and Toxicity of Busulfex as Part of a High Dose Chemotherapy Preparative Regimen in Autologous Hematopoietic Stem Cell Transplantation for Patients With Plasma Cell Myeloma
- To compare relapse-free survival and overall survival of patients with multiple myeloma
treated with IV busulfan vs historical control patients treated with oral busulfan when
administered with cyclophosphamide as a conditioning regimen prior to autologous
hematopoietic stem cell transplantation.
- To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered
with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem
OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose
cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous
hematopoietic stem cell transplantation on day 0.
After completion of study treatment, patients are followed up periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimated using Kaplan-Meier method. A 95% confidence interval will be constructed to see how they compare to historical values.
at 6 months
Ronald M. Sobecks, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|