Overview

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