UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

I

The purpose of this study is to determine response (PR, CR), response duration, and event-free and overall survival of combined PS-341 and thalidomide and to evaluate the quantitative and qualitative toxicities of the combined regimen

• The study population includes patients 18 years of age and older, who have a history of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after >1 line of prior therapy for myeloma. Patients must have a performance status of £ 2 as per SWOG scale

Patients will have a 1-cycle run-in period, depending on their prior exposure to PS-341 and/or thalidomide. Specifically, no prior PS-341 nor thalidomide — patients will receive PS-341 alone for one cycle. Thalidomide will be added with cycle 2. Prior PS-341 and no prior thalidomide — patients will receive thalidomide alone for 1 cycle. PS-341 will be added with cycle 2. Prior thalidomide and no prior PS-341 — patients will receive PS-341 alone for one cycle. Thalidomide will be added with cycle 2. Prior PS-341 and prior thalidomide — patients will receive both PS-341 and thalidomide from the beginning.

A cycle of PS-341 treatment will consist of twice-a-week administration on Monday and Thursday for 2 weeks (on days 1, 4, 8, and 11) followed by a 10-day rest period (days 12 - 21). This 3-week period will be considered a treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). A maximum of 8 treatment cycles can be administered to a patient. Thalidomide will be administered by mouth every night to continue for the duration of the study

Wanda MacNeil, BS, CCRA
Director, Clinical Research/Data Management
Myeloma Institute for Research and Therapy
MacNeilWandaD@uams.edu
501.686.8398