At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High-dose Gemcitabine, Busulfan and Melphalan With Autologous Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma
In Brief
A Phase 2 clinical trial evaluating Palifermin, Dexamethasone, and 5 other interventions for Myeloma. Completed, enrolled 75 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.
Study Details
Timeline
Interventions
60 micrograms/kg infused as an IVP (by vein) over 15-30 seconds Days -12 to -10 and Days 0 to +2 as an outpatient. 60 micrograms/kg by vein on Days -13 to -11 and on Days 0, +1 and +2 as in inpatient.
8 mg IV twice a day by vein over 15 minutes Days -9 through -2 as an outpatient or inpatient.
1875 mg/m\^2 IV (75 mg/ m2 bolus followed by 1800 mg/m\^2 over 3 hours) on Day -8 and Day -3 as an outpatient or inpatient.
32 mg/m2 test dose with PKs as outpatient before Day -12, or as an inpatient on Day -10. Busulfan AUC 4,000 by vein on Days -8 to -5 as an outpatient or inpatient.
60 mg/m\^2 IV on Days -3 and -2 over 30 minutes on both days as an outpatient or inpatient.
On Day 0, stem cells returned to body by vein over 30-60 minutes.
5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.