This is a clinical trial for men and women with relapse refractory multiple myeloma. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. This is the first study where CC-122 is being given to people. CC-122 is not approved yet by United States Food and Drug Administration (FDA) or any other health regulatory authority to treat cancer. CC-122 comes in the form of capsules that are taken by mouth and swallowed with water. CC-122 is made by Celgene Corporation, the study sponsor.
The study will look at the following information:
Part A of the study is full and only Part B is accruing subjects. Part B will include approximately 240 people. The goal of Part B is to test the highest, and/or the near-highest tolerated dose levels found in Part A in larger groups of patients. Additional goals in Part B are to test the safety and tolerability of higher doses of CC-122 than Part A and to compare different intermittent schedules (5 out of 7 days per week or 21 out of 28 days per month) and to compare the tolerability of these different doses and schedules. In addition, a new capsule, which possibly results in more drug getting into the body, will be assessed for safety and tolerability in Part B. Part B will take about 36 months to complete. At Weill Cornell, this study is only open to subjects with multiple myeloma.