PK parameters for the first and fourth doses of elotuzumab*
| Dose, mg/kg . | Dose . | T1/2λ, days† . | Tmax, hr . | Cmax, mcg/mL‡ . | Vz, mL† . | CL, mL/hr† . | AUCτ, mcg*hr/mL . | AUCinf, mcg*hr/mL . |
|---|---|---|---|---|---|---|---|---|
| 0.5 | 1 | 2.1 ± 0.5 | 1.9 ± 1.0 | 11.3 ± 3.0 | 4291.2 ± 852.5 | 71.4 ± 19.9 | 596.8 ± 151.5 | 634.1 ± 144.9 |
| 4 | NA | 3.2 ± 2.8 | 7.5 ± 2.5 | NA | NA | NA | NA | |
| 1.0 | 1 | 3.2 ± 0.6 | 1.5 ± 0.0 | 17.6 ± 4.8 | 6194.8 ± 2477.9 | 65.2 ± 16.7 | 2328.2 ± 1413.7 | 1342.6 ± 387.0 |
| 4 | NA | 2.0 ± 0.8 | 25.7 ± 19.9 | NA | NA | 5777.5 ± 6395.8 | 1322.0 ± NA | |
| 2.5 | 1 | 4.4 ± 1.8 | 2.8 ± 0.9 | 45.2 ± 12.1 | 4656.3 ± 1932.8 | 40.4 ± 28.3 | 5319.5 ± 2892.3 | 6337.4 ± 3911.5 |
| 4 | NA | 3.5 ± 2.3 | 37.6 ± 24.9 | NA | NA | 5508.9 ± NA | 5884.2 ± 511.9 | |
| 5.0 | 1 | 6.6 ± NA | 4.4 ± 1.7 | 90.5 ± 27.1 | 4757.7 ± 240.9 | 22.1 ± NA | 14 403.9 ± 4086.1 | 13 718.0 ± NA |
| 4 | NA | 4.2 ± 2.1 | 160.7 ± 58.9 | NA | NA | 46 420.5 ± NA | 14 172.8 ± NA | |
| 10 | 1 | 4.6 ± 0.1 | 4.2 ± 2.4 | 337.4 ± 65.8 | 2976.9 ± 366.5 | 15.3 ± 8.6 | 40 544.4 ± 28 741.7 | 28 378.2 ± 12 432.9 |
| 4 | NA | 4.8 ± 1.4 | 216.6 ± 37.2 | NA | NA | 26 506.4 ± NA | 27 220.0 ± NA | |
| 20 | 1 | 7.8 ± 0.3 | 6.8 ± 6.4 | 415.3 ± 90.0 | 4781.6 ± 1482.8 | 15.7 ± 4.9 | 74 850.6 ± 17 969.5 | 86 152.6 ± 26 732.0 |
| 4 | NA | 4.2 ± 1.4 | 563.0 ± 112.5 | NA | NA | 162 390.2 ± 89 871.7 | NA |
| Dose, mg/kg . | Dose . | T1/2λ, days† . | Tmax, hr . | Cmax, mcg/mL‡ . | Vz, mL† . | CL, mL/hr† . | AUCτ, mcg*hr/mL . | AUCinf, mcg*hr/mL . |
|---|---|---|---|---|---|---|---|---|
| 0.5 | 1 | 2.1 ± 0.5 | 1.9 ± 1.0 | 11.3 ± 3.0 | 4291.2 ± 852.5 | 71.4 ± 19.9 | 596.8 ± 151.5 | 634.1 ± 144.9 |
| 4 | NA | 3.2 ± 2.8 | 7.5 ± 2.5 | NA | NA | NA | NA | |
| 1.0 | 1 | 3.2 ± 0.6 | 1.5 ± 0.0 | 17.6 ± 4.8 | 6194.8 ± 2477.9 | 65.2 ± 16.7 | 2328.2 ± 1413.7 | 1342.6 ± 387.0 |
| 4 | NA | 2.0 ± 0.8 | 25.7 ± 19.9 | NA | NA | 5777.5 ± 6395.8 | 1322.0 ± NA | |
| 2.5 | 1 | 4.4 ± 1.8 | 2.8 ± 0.9 | 45.2 ± 12.1 | 4656.3 ± 1932.8 | 40.4 ± 28.3 | 5319.5 ± 2892.3 | 6337.4 ± 3911.5 |
| 4 | NA | 3.5 ± 2.3 | 37.6 ± 24.9 | NA | NA | 5508.9 ± NA | 5884.2 ± 511.9 | |
| 5.0 | 1 | 6.6 ± NA | 4.4 ± 1.7 | 90.5 ± 27.1 | 4757.7 ± 240.9 | 22.1 ± NA | 14 403.9 ± 4086.1 | 13 718.0 ± NA |
| 4 | NA | 4.2 ± 2.1 | 160.7 ± 58.9 | NA | NA | 46 420.5 ± NA | 14 172.8 ± NA | |
| 10 | 1 | 4.6 ± 0.1 | 4.2 ± 2.4 | 337.4 ± 65.8 | 2976.9 ± 366.5 | 15.3 ± 8.6 | 40 544.4 ± 28 741.7 | 28 378.2 ± 12 432.9 |
| 4 | NA | 4.8 ± 1.4 | 216.6 ± 37.2 | NA | NA | 26 506.4 ± NA | 27 220.0 ± NA | |
| 20 | 1 | 7.8 ± 0.3 | 6.8 ± 6.4 | 415.3 ± 90.0 | 4781.6 ± 1482.8 | 15.7 ± 4.9 | 74 850.6 ± 17 969.5 | 86 152.6 ± 26 732.0 |
| 4 | NA | 4.2 ± 1.4 | 563.0 ± 112.5 | NA | NA | 162 390.2 ± 89 871.7 | NA |
Data are mean ± SD.
VZ indicates volume of distribution; and NA, not applicable.
Patients with positive immunogenicity response were excluded from these PK analyses.
Parameter estimation for the fourth dose was excluded as the steady-state concentration was not achieved or data were insufficient for the estimation.
Observed data.