Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma|
- To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
- To determine toxicities associated with thalidomide in patients with multiple myeloma
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083577
|United States, Arkansas|
|University of Arkansas for Medical Sciences/MIRT|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Bart Barlogie, M.D.||UAMS|