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Summary  Renal impairment ( RI ) is a major complication of multiple myeloma ( MM ). This study aimed to characterize the single‐dose pharmacokinetics ( PK ) of the oral proteasome inhibitor, ixazomib, in cancer patients with normal renal function [creatinine clearance (CrCl) ≥90 ml/min;  n  =   20), severe  RI  (CrCl <30 ml/min;  n  =   14), or end‐stage renal disease requiring haemodialysis ( ESRD ;  n  =   7).  PK  and adverse events ( AE s) were assessed after a single 3 mg dose of ixazomib. Ixazomib was highly bound to plasma proteins (~99%) in all renal function groups. Unbound and total systemic exposures of ixazomib were 38% and 39% higher, respectively, in severe  RI / ESRD  patients versus patients with normal renal function. Total ixazomib concentrations were similar in pre‐ and post‐dialyser samples collected from  ESRD  patients; therefore, ixazomib can be administered without regard to haemodialysis timing. Except for anaemia, the incidence of the most common  AE s was generally similar across groups, but grade 3 and 4  AE s were more frequent in the severe  RI / ESRD  groups versus the normal group (79%/57% vs. 45%), as were serious  AE s (43%/43% vs. 15%). The  PK  and safety results support a reduced ixazomib dose of 3 mg in patients with severe  RI / ESRD .

british journal of haematology

A pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end‐stage renal disease requiring haemodialysis