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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 CASE 1A07

CC CC639

Hospital Main Campus

Disease Blood & Marrow Transplant (BMT), Multiple Myeloma

Drug Busulfex

Description

Description

  1. 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.
  2. 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

Inclusion Criteria

  1. Patients with a diagnosis of plasma cell myeloma
  2. Patients with cardiac ejection fraction ≥ 45% or clearance by CCF cardiologist
  3. Patients with DLCO ≥ 45% predicted or clearance by CCF pulmonologist
  4. Patient with previously harvested peripheral blood progenitor cells with a minimum of 2 x 10^6 CD34+ cells/kg harvested
  5. Patient is greater than 18 years of age
Exclusion Criteria

Exclusion Criteria

  1. Patients receiving total body irradiation
  2. Non-myeloablative/reduced-intensity conditioning
  3. Pregnant or breast-feeding patients
  4. HIV positive
  5. Patient with Serum creatinine > 2.0
  6. Prior HSC transplant