Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

PH Ib 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

The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.

Inclusion Criteria:

• Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:

  1. Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but not requiring dialysis
  2. End-stage renal disease: requiring hemodialysis
  3. Normal renal function: estimated CrCl ≥90 ml/min

• Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory

• Prior Lenalidomide exposure is permitted only if the subject did not discontinue Lenalidomide due to a Grade ≥3 related Adverse Event (AE)

Exclusion Criteria:

• Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma
• Active plasma cell leukemia
• All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved
• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Acute renal failure