Elotuzumab can be used for the treatment of patients with multiple myeloma and renal dysfunction without dose adjustment, according to a study published in Clinical Lymphoma, Myeloma & Leukemia.1
Investigators evaluated the pharmacokinetics and safety of elotuzumab combined with lenalidomide and dexamethasone in patients with multiple myeloma and renal impairment in this phase 1b study.
Investigators enrolled patients with multiple myeloma and normal renal function (NRF; creatinine clearance [CrCl] ≥ 90 mL/min), severe renal impairment (SRI; CrCl < 30 mL/min, not requiring dialysis), or end-stage renal disease (ESRD; requiring dialysis). A total of 26 patients received elotuzumab (10 mg/kg), lenalidomide (5 – 25 mg), and dexamethasone (40 mg) in 28-day cycles until disease progression or unacceptable toxicity. The study’s primary endpoint was single-dose elotuzumab pharmacokinetics.
Median age of patients was 63 years; 8 had NRF, 9 had SRI, and 9 had ESRD. Patients with NRF had a median baseline CrCl of 105 mL/min and those with SRI had a median of 26 mL/min.
Disease progression mostly contributed to treatment discontinuation in 6 patients with NRF, 4 with SRI, and 5 with ESRD.
Results showed that mean elotuzumab serum concentrations were comparable across groups and no statistically significant differences were seen in the maximum observed serum concentration, area under the concentration-time curve from time 0 to the last quantifiable serum concentration, or area under the concentration-time curve from time 0 to infinity.
RELATED: Vorinostat Plus Bortezomib Active in Refractory Myeloma
In regard to safety, ≥ 1 adverse events occurred in all patients. Grade 3-4 adverse events occurred in 7 patients with NRF, 8 in patients with SRI, and 7 in patients with ESRD.
Overall response rates were 75% in the NRF group, 67% in the SRI group, and 56% in the ESRD group.
- Berdeja J, Jagannath S, Zonder J, et al. Pharmacokinetics and safety of elotuzumab combined with lenalidomide and dexamethasone in patients with multiple myeloma and various levels of renal impairment: results of a phase 1b study. Clin Lymphoma, Myeloma Leuk. 2016;16(3):129-138.