A Phase 2 Biomarker Study of Elotuzumab (Humanized anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma
ID Number 12-1129Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
Patients with smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment. There are currently no approved therapies for smoldering multiple myeloma. The purpose of this study is to determine the effectiveness and safety of elotuzumab in patients with high risk smoldering myeloma.
Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Elotuzumab was observed to kill myeloma cells in laboratory studies.
Elotuzumab has been studied already in patients with advanced multiple myeloma, and while it did not show significant activity by itself, it has demonstrated an increase in anti-myeloma activity when combined with other drugs. It is possible that elotuzumab did not work by itself because its activity depends on an intact immune system – which patients with advanced myeloma having had many prior treatments may not have. For this reason, elotuzumab is now being studied in patients with early, untreated myeloma, also known as asymptomatic myeloma.
The Sponsor wants to find out what effects, good or bad, elotuzumab may have on you. There are no placebos (a placebo is an inactive substance which may resemble an active agent but has no medical value) used in this trial.
Recruiting Patients: Yes