Table 1 Minimisation factors and baseline characteristics.
ICD (n = 57) N (%) | CD (n = 53) N (%) | Total (n = 110) N (%) | ||
|---|---|---|---|---|
Minimisation factors | ||||
Age at randomisation | <60 | 10 (17.5) | 10 (18.9) | 20 (18.2) |
60–69 | 18 (31.6) | 15 (28.3) | 33 (30.0) | |
70+ | 29 (50.9) | 28 (52.8) | 57 (51.8) | |
Number of prior lines of therapy | >3 | 45 (78.9) | 44 (83.0) | 89 (80.9) |
≤3 | 12 (21.1) | 9 (17.0) | 21 (19.1) | |
β2 microglobulin | < 3.5 mg/L | 22 (38.6) | 22 (41.5) | 44 (40.0) |
3.5–5.5 mg/L | 20 (35.1) | 16 (30.2) | 36 (32.7) | |
≥5.5 mg/L | 15 (26.3) | 15 (28.3) | 30 (27.3) | |
Baseline characteristics | ||||
Age | Median (range) | 70.0 (49.0, 82.0) | 70.0 (46.0, 82.0) | 70.0 (46.0, 82.0) |
Gender | Male | 33 (57.9) | 30 (56.6) | 63 (57.3) |
Female | 24 (42.1) | 23 (43.4) | 47 (42.7) | |
Prior lines of therapy | Median (range) | 5 (1, 5 + ) | 4 (1, 5 + ) | 4 (1, 5 + ) |
>4 | 29 (50.8) | 24 (46.2) | 53 (48.2) | |
≤4 | 28 (49.2) | 29 (53.8) | 57 (51.8) | |
Prior Therapies | Bortezomib | 56 (98.2) | 51 (96.2) | 107 (97.3) |
Lenalidomide | 57 (100.0) | 53 (100.0) | 110 (100.0) | |
Thalidomide | 55 (96.5) | 52 (98.1) | 107 (97.3) | |
Anti-CD38 | 11 (19.3) | 9 (17.0) | 20 (18.2) | |
Prior ASCT | 30 (52.6) | 29 (55.8) | 59 (53.6) | |
Time since diagnosis (years) | Median (range) | 7.3 (1.8, 21.0) | 6.7 (2.1, 20.5) | 6.8 (1.8, 21.0) |
ECOG performance status | 0 | 12 (21.1) | 18 (34.0) | 30 (27.3) |
1 | 40 (70.2) | 28 (52.8) | 68 (61.8) | |
2 | 5 (8.8) | 7 (13.2) | 12 (10.9) | |
Charlson Comorbidity Index score | 0-2 | 41 (71.9) | 40 (75.5) | 81 (73.6) |
>2 | 16 (28.1) | 13 (24.5) | 29 (26.4) | |
Frailty scorea | Frail | 46 (80.7) | 35 (66.0) | 81 (73.6) |
Non-frail | 11 (19.3) | 18 (34.0) | 29 (26.4) | |
Median (range) | 2 (1-5) | 2 (1–4) | 2 (1-5) | |
ISS at baseline | I | 15 (26.3) | 14 (26.4) | 29 (26.4) |
II | 23 (40.4) | 23 (43.4) | 46 (41.8) | |
III | 17 (29.8) | 16 (30.2) | 33 (30.0) | |
Not available/missing | 2 (3.6) | 0 | 2 (1.8) | |
Genetics data at baseline | Full | 27 (47.4) | 21 (39.6) | 48 (43.6) |
Partial | 7 (12.3) | 12 (22.6) | 19 (17.3) | |
Not available | 23 (40.4) | 20 (37.7) | 43 (39.1) | |
High risk lesions (n = 67) | Del1p | 3 (8.8) | 6 (18.2) | 9 (13.4) |
Gain1q | 16 (47.1) | 20 (60.6) | 36 (53.7) | |
Del17p | 8 (23.5) | 5 (15.2) | 13 (19.4) | |
High risk lesions (n = 48) | t(4;14) | 2 (7.4) | 0 (0) | 2 (4.2) |
t(14;16) / t(14,20) | 2 (7.4) | 2 (9.5) | 4 (8.3) | |
