Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan
at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily
area under the plasma concentration versus time curve (AUC) of approximately 5,000
mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in
adult patients receiving autologous or allogeneic transplantation for lymphoid
malignancies or myeloma.
2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this
regimen.
3. To determine the disease-free and overall survival of patients receiving this
preparative regimen.
4. To determine the treatment-related morbidity and mortality of this combination of drugs.