Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title 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
IRB CASE1A07
CC CC639
Hospital Main Campus
Disease Blood & Marrow Transplant (BMT), Multiple Myeloma
Drug Busulfex
Description
- Primary Objective:
- To compare relapse-free survival and overall survival between Busulfex and oral Busulfan when used for conditioning with cyclophosphamide in plasma cell myeloma patients undergoing autologous HSCT.
- Secondary Objectives:
- To compare pulmonary toxicity rates between Busulfex and oral Busulfan when used for conditioning with cyclophosphamide in plasma cell myeloma patients undergoing autologous HSCT.
Inclusion Criteria
- Patients with a diagnosis of plasma cell myeloma
- Patients with cardiac ejection fraction ≥ 45% or clearance by CCF cardiologist
- Patients with DLCO ≥ 45% predicted or clearance by CCF pulmonologist
- Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10^6 CD34+ cells/kg harvested
- Patient is greater than 18 years of age
Exclusion Criteria
- Patients receiving total body irradiation
- Non-myeloablative/reduced-intensity conditioning
- Pregnant or breast-feeding patients
- HIV positive
- Patient with Serum creatinine > 2.0
- Prior HSC transplant