A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial

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 parameter^a	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)
C_max (ng/ml)	487 (35.0)	572 (33.2)	596 (30.2)
T_max (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)
t_1/2 (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, C_max Maximum observed plasma concentration, CrCL Creatinine clearance, t_1/2 Terminal phase half-life, T_max Time to C_max, Vz/F Apparent volume of distribution during terminal phase after non-intravenous administration.

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