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Sponsored by: |
University of Arkansas |
---|---|
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083577 |
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 |
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.
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 |
Principal Investigator: | Bart Barlogie, M.D. | UAMS |
Study ID Numbers: | UARK 98-003 |
Study First Received: | May 25, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00083577 |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma Thalidomide Anti-Angiogenesis |
Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |