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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Outcome Description:

Estimated using Kaplan-Meier method. A 95% confidence interval will be constructed to see how they compare to historical values.

Outcome Time Frame:

at 6 months

Safety Issue:

No

Principal Investigator

Ronald M. Sobecks, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE1A07

NCT ID:

NCT00941720

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195