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| Sponsored by: |
University of Arkansas |
| Information provided by: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00083577 |
Purpose
The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.
| Condition | Intervention | Phase |
|
Multiple Myeloma |
Drug: Thalidomide |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| Drug Information available for: | Thalidomide |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma |
| Estimated Enrollment: | 250 |
| Study Start Date: | February 1998 |
| Estimated Study Completion Date: | May 2005 |
Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. After week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide.
Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done once a month for the first six months of receiving thalidomide.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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. | UAMS |
More Information
Myeloma Institute for Research & Therapy website 
  |
| Study ID Numbers: | UARK 98-003 |
| First Received: | May 25, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00083577 |
| Health Authority: | United States: Food and Drug Administration |
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