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Sponsored by: |
University of Arkansas |
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083460 |
The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: PS-341 Drug: Thalidomide Drug: Dexamethasone |
Phase I |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide Bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma |
Estimated Enrollment: | 80 |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator |
Drug: PS-341
Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
Drug: Thalidomide
In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
Drug: Dexamethasone
A dose of 20mg for cylces 3-8.
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2: Active Comparator |
Drug: PS-341
Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
Drug: Thalidomide
In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
Drug: Dexamethasone
A dose of 20mg for cylces 3-8.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
University of Arkansas for Medical Sciences/MIRT | |||||
Little Rock, Arkansas, United States, 72205 |
University of Arkansas |
Principal Investigator: | Barlogie Barthel, M.D. Ph.D | University of Arkanas for Medical Sciences website |
Myeloma Institute for Research & Therapy website 
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Responsible Party: | University_Of_Arkansas ( Brooke Carter, CRA ) |
Study ID Numbers: | UARK 2001-37 |
First Received: | May 24, 2004 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00083460 |
Health Authority: | United States: Food and Drug Administration |
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