Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00941720|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2009
Results First Posted : April 2, 2014
Last Update Posted : May 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: busulfan Drug: cyclophosphamide Procedure: autologous hematopoietic stem cell transplantation||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 11, 2009|
|Actual Primary Completion Date :||February 28, 2013|
|Estimated Study Completion Date :||November 2018|
|Experimental: Busulfan Treatment||
IV busulfan 0.8 mg/kg every 6 hours x 16 doses
IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
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
- Relapse-free Survival [ Time Frame: at 6 months ]Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .
- Overall Survival [ Time Frame: at 6 months ]Number of patients alive at the end of the study period
- Pulmonary Toxicity [ Time Frame: At 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941720
|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|