Table 4.
Plasma lenalidomide pharmacokinetic (PK) parameters when administered alone or in combination with dexamethasone (PK cohort, n = 11)
| PK parametera |
Day 1 |
Day 7: lenalidomide alone |
Day 8: lenalidomide plus low-dose dexamethasone |
|---|---|---|---|
| (n = 11) | (n = 10) | (n = 10) | |
| Tmax (h) |
0.93 (0.50–3.17) |
1.50 (0.50–3.08) |
1.00 (0.50–2.98) |
| Cmax (ng/ml) |
574 (28.3) |
478 (19.3) |
494 (19.9) |
| AUCt (h•ng/ml) |
2323 (40.1) |
1963 (36.6) |
2093 (41.2) |
| AUC∞ (h•ng/ml) |
2403 (41.2) |
2141 (45.4) |
2162 (42.6) |
| t1/2 (h) |
3.34 (41.9) |
2.79 (32.6) |
3.08 (46.8) |
| CL/F (ml/min) |
173 (41.2) |
195 (45.4) |
193 (42.6) |
| RAC (Cmax) |
NA |
0.84 (29.2) |
NA |
| RAC (AUCτ) | NA | 0.89 (17.9) | NA |
aGeometric mean (geometric coefficient of variation %) data are presented for all parameters except Tmax for which median (range) data are presented.
Abbreviations: AUC Area under the plasma concentration–time curve, AUC∞ AUC from time 0 to infinity, CL/F Apparent total plasma clearance, Cmax Maximum observed plasma concentration, NA Not applicable, RAC (AUCτ) Accumulation ratio between Days 1 and 7 based on AUC, RAC (Cmax) Accumulation ratio between Days 1 and 7 based on Cmax, t1/2 Terminal phase half-life, Tmax Time to Cmax.