Table 1 Baseline characteristics
Characteristics | Part 1 patients | RP2D patients | All patients |
|---|---|---|---|
n = 61 | n = 38 | N = 87a | |
Median age (range), yr | 64 (36–81) | 71 (38–85) | 67 (36–85) |
Female sex, n (%) | 31 (50.8) | 15 (39.5) | 41 (47.1) |
Median time since initial diagnosis (range), yr | 5 (1–15) | 4 (1–21) | 5 (1–21) |
Eastern Cooporative Oncology Group performance status | |||
0 | 20 (32.8) | 10 (26.3) | 25 (28.7) |
1 | 35 (57.4) | 26 (68.3) | 55 (63.2) |
2 | 6 (9.8) | 1 (2.7) | 6 (6.9) |
Missing | 0 (0.0) | 1 (2.7) | 1 (1.2) |
Derived International Staging System stage at baseline, n (%) | |||
1 | 20 (16.3) | 7 (18.4) | 22 (25) |
2 | 22 (36.1) | 10 (26.3) | 30 (34.4) |
3 | 10 (16.4) | 12 (31.6) | 19 (21.8) |
Missing | 9 (14.8) | 9 (23.7) | 16 (18.4) |
Baseline cytogenetics, n (%) | |||
High riskb | 14 (23.0) | 7 (18.5) | 16 (18.4) |
Standard riskc | 18 (29.5) | 14 (36.8) | 29 (33.3) |
Missing | 29 (47.5) | 17 (44.7) | 42 (48.3) |
Median no. of previous therapies (range) | 3 (1–5) | 3 (1–6) | 3 (1–6) |
Previous therapies, n (%) | |||
Autologous stem cell transplantation | 49 (80.3) | 18 (47.4) | 60 (69.0) |
Lenalidomide | 61 (100.0) | 38 (100.0) | 87 (100.0) |
PI | 61 (100.0) | 38 (100.0) | 87 (100.0) |
Anti-CD38 | 36 (59.0) | 30 (78.9) | 58 (66.7) |
Triple-class exposure | 36 (59.0) | 30 (78.9) | 58 (66.7) |
Refractory to, n (%) | |||
Lenalidomide | 58 (95.1) | 36 (94.7) | 84 (96.6) |
PI | 53 (86.9) | 32 (84.2) | 75 (86.2) |
Anti-CD38 | 36 (59.0) | 30 (78.9) | 58 (66.7) |
Triple-class refractory, n (%) | 30 (49.2) | 24 (63.2) | 48 (55.2) |