Table 2.
Patient baseline demographics and disease characteristics
| Characteristic | All treated patients (n = 72) | Patients treated at MTD (n = 39) |
|---|---|---|
| Median age, y (range) | 59 (29-77)* | 60 (29-77) |
| Male | 41 (56.9) | 19 (48.7) |
| Race | ||
| White | 58 (80.6) | 31 (79.5) |
| Black | 6 (8.3) | 3 (7.7) |
| Other | 8 (11.1) | 5 (12.8) |
| MM subtype | ||
| IgG | 56 (77.8) | 32 (82.1) |
| IgA | 14 (19.4) | 7 (18.0) |
| κ light chain | 5 (6.9) | 0 |
| λ light chain | 4 (5.6) | 0 |
| ISS stage II/III | 38 (52.8) | 21 (53.8) |
| Durie-Salmon stage II/III | 59 (81.9) | 32 (82.1) |
| del(13)/del(13q)/hypodiploid, t(4;14), t(14;16), or 17p† | 33 (45.8) | 19 (48.7) |
| del(13)/hypodiploid, t(4;14), t(14;16), or 17p‡ | 19 (26.4) | 10 (25.6) |
| Karnofsky performance status ≤ 80% | 29 (40.3) | 19 (48.7) |
| Lytic lesions | ||
| None | 19 (26.4) | 11 (28.2) |
| 1-3 bones | 17 (23.6) | 11 (28.2) |
| > 3 bones | 36 (50.0) | 17 (43.6) |
Values are expressed as n (%) except for age.
*
Age (mean ± SD) of ASCT patients, 56 ± 10 years, n = 49; and non-ASCT patients, 65 ± 9 years, n = 23 (P = .0009).
†
Poor-prognosis abnormalities (patients without any of these abnormalities represent standard risk).4
‡
High-risk abnormalities (excludes patients with del(13q) by FISH as the sole cytogenetic risk). n values for poor-prognosis and high-risk abnormalities were 67 for all patients and 37 for the phase 2 population.