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
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
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
OBJECTIVES:
Primary
- 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.
Secondary
- To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered
with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem
cell transplantation.
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.
Inclusion Criteria
INCLUSION CRITERIA:
- Patients with a diagnosis of plasma cell myeloma
- Patients with cardiac ejection fraction >= 45% or clearance by Cleveland Clinic
Faculty (CCF) cardiologist
- Patients with diffusion capacity of carbon monoxide (DLCO) >= 45% predicted or
clearance by CCF pulmonologist
- Patient with previously harvested peripheral blood progenitor cells with a minimum of
2 x 10^6 CD 34+ cells/kg harvested
EXCLUSION CRITERIA:
- Patients receiving total body irradiation
- Non-myeloablative/reduced-intensity conditioning
- Pregnant and breast feeding patients
- Human immunodeficiency virus (HIV) positive
- Patients with serum creatinine > 2.0
- Prior Hematopoietic Stem Cell (HSC) transplant
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relapse-free survival
Outcome Description:
Estimated using Kaplan-Meier method. A 95% confidence interval will be constructed to see how they compare to historical values.
Outcome Time Frame:
at 6 months
Safety Issue:
No
Principal Investigator
Ronald M. Sobecks, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE1A07
NCT ID:
NCT00941720
Start Date:
June 2009
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
