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.
Phase:
Phase 1
Details
Lead Sponsor:
Guido Tricot
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.