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

• Status: Completed
• Trial end date: 2016-07-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

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