A Phase 1b Study of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma and Normal Renal Function, Severe Renal Impairment, or End Stage Renal Disease Requiring Dialysis
ID Number 12-0928Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
You have been asked to participate in this research study because you have multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. The purpose of this study is to determine if severe kidney impairment and end-stage kidney disease affect how your body processes elotuzumab. Earlier studies show that elotuzumab given with lenalidomide and dexamethasone has a favorable safety profile in patients with normal renal function or mild and moderate kidney impairment. It is unknown whether the same is true for patients who have severe kidney impairment or are dialysis dependent. This study will also look at the safety of elotuzumab given with lenalidomide and dexamethasone in patients with and without severe kidney impairment and end-stage kidney disease requiring dialysis.
Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. It is currently unknown whether the combination of elotuzumab with standard therapy is better than standard therapy alone.
Lenalidomide is a drug that changes the immune system and it may also get in the way of the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide in combination with dexamethasone is approved by the United States (US) Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least 1 prior multiple myeloma therapy. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. While the combination of lenalidomide and dexamethasone has not been approved by regulatory authorities for the treatment of newly diagnosed myeloma, it is a commonly used regimen in this setting.
Recruiting Patients: Yes