Table 4 Exposure (Cmax, Ctrough, and AUC0−τ) parameters for isatuximab in a typical patient, with accumulation ratios.

From: A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma

 

Cycle 1

Cycle 2

Steady state

Cmax (µg/ml)

Ctrough (µg/ml)

AUC0−τ (µg.h/ml)

Cmax (µg/ml)

Ctrough (µg/ml)

Cmax (µg/ml)

Ctrough (µg/ml)

AUC0−τ (µg.h/ml)

10 mg/kg Q2W

142

24.7

18,288

190

66.7

272

132

58,557

Accumulation ratio

   

1.34

2.70

1.92

5.35

3.20

10 mg/kg Q2W/Q4W

142

24.7

18,288

190

66.7

163.4

16.8

36,090

Accumulation ratio

   

1.34

2.70

1.15

0.68

–

20 mg/kg QW/Q2W

278

103

26,711

617

335

651

369

152,884

Accumulation ratio

   

2.22

3.26

2.34

3.60

–

  1. AUC0−τ predicted cumulative area under the plasma concentration curve from time zero to time τ, Cmax maximum plasma concentration, Ctrough plasma concentration before treatment administration during repeated dosing, QnW every n week.
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