Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | June 11, 2009 |
| End Date: | May 2019 |
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
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.
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.
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.
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.
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
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