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Sponsored by: |
University of Arkansas |
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00093028 |
The purpose of this study is
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: CC-5013 (Revlimid™) Drug: bortezomib |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Bortezomib Lenalidomide CC 5013 |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 2003-35, A Phase III Study of Bortezomib Versus Bortezomib in Two Doses in Combination With Revlimid™ for Patients Relapsing or Progressing on Total Therapy II (UARK 98-026) |
Enrollment: | 315 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Two new drugs BORTEZOMIB (Velcade®, PS-341) and REVLIMID (CC-5013) have been shown in recent studies to be effective in patients with advanced multiple myeloma. This study is being done to learn more about the best way to administer these drugs, either alone or in combination. Since it is not known at this time which treatment is the best, participants will be placed by chance in one of the three treatment groups:
This chance selection process is called randomization and is often used in research studies.
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: | Bart Barlogie, M.D., Ph.D. | UAMS Myeloma Institute for Research & Therapy |
Myeloma Institute for Research & Therapy website 
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Responsible Party: | UAMS ( Bart Barlogie, MD, PhD ) |
Study ID Numbers: | UARK 2003-35 |
First Received: | September 29, 2004 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00093028 |
Health Authority: | United States: Food and Drug Administration |
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