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.
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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.
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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.
Reference
- 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.
