At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of High-Dose Intravenous Busulfan Plus Melphalan With Allogeneic or Autologous Marrow or Peripheral Blood Progenitor Cell Transplantation for Lymphoid Malignancies or Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Busulfan and Melphalan for Multiple Myeloma and Lymphoma. Completed, enrolled 168 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Test Dose = 32 mg/m\^2 IV for 1 Day; 130 mg/m\^2 IV for 4 Days
70 mg/m\^2 IV for 2 Days