Phase 1
Completed N=26
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
Source: ClinicalTrials.gov NCT01393964 ↗Enrolled (actual)
26
Serious AEs
57.7%
Results posted
Jan 2016
Primary outcomePrimary: Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method — 217; 226; 218 µg/mL — p=0.704
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
217; 226; 218 | 0.704 |
| PRIMARY Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method |
39559; 50080; 45937; 46401; 60255; 51227 | 0.164 |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died |
0; 0; 0; 3; 5; 7 | — |
| SECONDARY Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose. |
1; 0; 0; 2; 1; 1 | — |
| SECONDARY Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests |
8; 9; 9; 0; 2; 6 | — |
| SECONDARY Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests |
0; 3; 7; 0; 0; 0 | — |
| SECONDARY Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests |
2; 3; 2; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:
- Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but not requiring dialysis
- End-stage renal disease: requiring hemodialysis
- 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
Data sourced from ClinicalTrials.gov (NCT01393964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.