Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
This trial is active, not recruiting.
|Condition||multiple myeloma and plasma cell neoplasm|
|Treatments||busulfan, cyclophosphamide, autologous hematopoietic stem cell transplantation|
|Sponsor||Case Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2009|
|End date||February 2013|
|Trial size||71 participants|
|Trial identifier||NCT00941720, CASE1A07, P30CA043703|
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.
|Intervention model||single group assignment|
time frame: at 6 months
time frame: at 6 months
time frame: At 6 months
Male or female participants at least 18 years old.
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
|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|
|Principal investigator||Ronald M. Sobecks, MD|
|Description||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.|
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