UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma
Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341
(1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg). The first
six patients in each group will receive PS-341 alone for the first cycle, and thalidomide
will be added on day 22. If the combination is found to be safe in these first 6 patients,
the remaining patients in each group will be enrolled. Initially, these patients will
receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the
first 6 patients in each thalidomide dose cohort.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma
until pt progresses or unexceptible toxicity
Yes
Barlogie Barthel, M.D. Ph.D
Principal Investigator
University of Arkanas for Medical Sciences website
United States: Food and Drug Administration
UARK 2001-37
NCT00083460
December 2001
November 2007
Name | Location |
---|---|
University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |