Status:
COMPLETED
Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 m...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00941720
Start Date
June 11 2009
End Date
February 28 2013
Last Update
July 24 2020
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195