Overview

This trial is active, not recruiting.

Condition multiple myeloma and plasma cell neoplasm
Treatments busulfan, cyclophosphamide, autologous hematopoietic stem cell transplantation
Phase phase 2
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
busulfan BSF
IV busulfan 0.8 mg/kg every 6 hours x 16 doses
cyclophosphamide CPM
IV cyclophosphamide 60 mg/kg over 4 hours x 2 days
autologous hematopoietic stem cell transplantation
infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0

Primary Outcomes

Measure
Relapse-free Survival
time frame: at 6 months
Overall Survival
time frame: at 6 months

Secondary Outcomes

Measure
Pulmonary Toxicity
time frame: At 6 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.