Table 5.
Comparison of plasma lenalidomide pharmacokinetic parameters (administered with dexamethasone) in different populations of patients with relapsed myeloma and normal renal function (creatinine clearance ≥60 mL/min)
| PK parametera |
Caucasian MM patients |
Japanese MM patients |
Chinese MM patients |
|---|---|---|---|
|
n = 34 |
n = 12 |
n = 9 |
|
| (MM-001 and MM-002)c | (MM-017)c | (MM-021)b | |
| Median age, years (range) |
59 (40–69) |
63 (43–66) |
55 (44–68) |
| Median body weight, kg (range) |
82 (50–118) |
59 (48–75) |
65 (54–84) |
| Median CrCl, ml/min (range) |
101 (65–155) |
91 (63–135) |
95 (63–154) |
| AUC∞ (h•ng/ml) |
2124 (28.6) |
2305 (23.7) |
2202 (30.6) |
| Cmax (ng/ml) |
487 (35.0) |
572 (33.2) |
596 (30.2) |
| Tmax (h) |
1.0 (0.4–4.0) |
1.0 (0.4–2.0) |
0.93 (0.5–1.0) |
| CL/F (ml/min) |
196 (28.7) |
181 (23.7) |
184 (30.7) |
| t1/2 (h) |
3.18 (20.7) |
2.70 (19.3) |
3.18 (39.0) |
| Vz/F (litres) | 54.0 (29.5) | 41.8 (14.3) | 50.7 (28.4) |
aGeometric mean (geometric coefficient of variation%) data are presented for all parameters except when stated as median (range).
bOnly includes patients with normal renal function (creatinine clearance ≥60 mL/min).
cSee references [8,9] and [Celgene data on file].
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, CrCL Creatinine clearance, t1/2 Terminal phase half-life, Tmax Time to Cmax, Vz/F Apparent volume of distribution during terminal phase after non-intravenous administration.