drugset / Trial / NCT00934232
Busulfan in Multiple Myeloma
Phase 1
Terminated
13 enrolled
Guido Tricot
Otsuka Pharmaceutical Development & Commercialization, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Two main objectives of the study are: Primary: To determine the MTD of Busulfex ® that can be given safely over the least number of days to myeloma patients who are either ≥65 years of age (Group 1) or have renal insufficiency (Group 2), defined as creatinine \>3mg/dL or creatinine clearance \<30 mL/min. Secondary: To perform pharmacokinetic (PK) studies to evaluate individual variability and the relationship to toxicities in each of the two groups at each proposed dose level.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-02
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 4.3 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 5.6 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 6.4 mg/kg | Intravenous |