Table 1.
Plasma lenalidomide exposure parameters in healthy volunteers and in patients with MM or MDS
| Cmax (ng/mL) | AUC∞ (hr ng/mL) | |||||
|---|---|---|---|---|---|---|
| Disease | Dose (mg) | Patients (n) | Geometric mean (CV%) | Range | Geometric mean (CV%) | Range |
| Healthy | 10 | 55 | 155 (30.1) | 76–321 | 536 (18.7) | 369–974 |
| 50 | 54 | 698 (31.1) | 301–1522 | 2674 (19.8) | 1853–5013 | |
| MM | 5 | 6 | 99 (47.4) | 58–213 | 535 (58.5) | 358–1484 |
| 10 | 10 | 208 (41.9) | 100–419 | 989 (57.7) | 620–3354 | |
| 25 | 6 | 555 (17.5) | 446–740 | 2253 (24.8) | 1593–2956 | |
| 50 | 20 | 994 (33.3) | 603–2413 | 4663 (38.3) | 2343–11,647 | |
| MDS | 10 | 12 | 179 (32.6) | 110–286 | 933 (32.6) | 574–1733 |
AUC∞, area under the curve from time zero to infinity; Cmax, maximum plasma concentration; CV, coefficient of variance; MDS, myelodysplastic syndromes; MM, multiple myeloma.