UARK 2003-25: A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency
This trial will determine the maximal dose of Busulfex® that can be given in a two, three,
or four day period with acceptable toxicity to myeloma patients, who either are > or = 65
years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine
clearance < 30 ml/min.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients
maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min
three years
Yes
Frits van Rhee, MD, PhD
Principal Investigator
UAMS
United States: Institutional Review Board
2003-25
NCT00113919
June 2004
October 2009
Name | Location |
---|---|
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy | Little Rock, Arkansas 72205 |