UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
Bart Barlogie, M.D.
United States: Food and Drug Administration
|University of Arkansas for Medical Sciences/MIRT||Little Rock, Arkansas 72205|