Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: autologous hematopoietic stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Relapse-free survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier method. A 95% confidence interval will be constructed to see how they compare to historical values.
- Overall survival [ Time Frame: at 6 months ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier method. A 95% confidence interval will be constructed to see how they compare to historical values.
- Pulmonary toxicity [ Time Frame: baseline and at 6 weeks ] [ Designated as safety issue: Yes ]Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.
|Study Start Date:||June 2009|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: Busulfan Treatment||
IV busulfan 0.8 mg/kg every 6 hours x 16 doses
Other Names:Drug: cyclophosphamide
IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
Other Names:Procedure: autologous hematopoietic stem cell transplantation
infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0
- 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 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.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Ronald M. Sobecks, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|