Table 1.
Key patient demographic and baseline characteristics according to treatment group and MRD status (randomized population)
| Characteristic | MRD negative (n = 69) | MRD positive (n = 233) | ||
|---|---|---|---|---|
| Isa-Kd (n = 53) | Kd (n = 16) | Isa-Kd (n = 126) | Kd (n = 107) | |
| Age, y | ||||
| Median | 64.0 | 65.5 | 65.0 | 63.0 |
| Range | 37-83 | 33-78 | 38-86 | 38-90 |
| Age by category | ||||
| <65 y | 29 (54.7) | 8 (50.0) | 59 (46.8) | 58 (54.2) |
| ≥65-74 y | 20 (37.7) | 6 (37.5) | 54 (42.9) | 41 (38.3) |
| ≥75 y | 4 (7.5) | 2 (12.5) | 13 (10.3) | 8 (7.5) |
| eGFR (MDRD* formula) | ||||
| No. of evaluable patients | 49 | 15 | 116 | 96 |
| <60 mL/min/1.73 m2 | 13 (26.5) | 2 (13.3) | 30 (25.9) | 16 (16.7) |
| ≥60 mL/min/1.73 m2 | 36 (73.5) | 13 (86.7) | 86 (74.1) | 80 (83.3) |
| ISS stage at initial diagnosis | ||||
| Stage I | 10 (18.9) | 8 (50.0) | 30 (23.8) | 25 (23.4) |
| Stage II | 13 (24.5) | 6 (37.5) | 40 (31.7) | 42 (39.3) |
| Stage III | 17 (32.1) | 2 (12.5) | 35 (27.8) | 23 (21.5) |
| Unknown | 13 (24.5) | 0 | 21 (16.7) | 17 (15.9) |
| LDH more than the ULN | 13 (24.5) | 2/15 (13.3) | 31/123 (25.2) | 15 (14.0) |
| Prior lines of therapy | ||||
| Median | 1 | 1 | 2 | 2 |
| Range | 1-4 | 1-3 | 1-4 | 1-4 |
| 1 line | 28 (52.8) | 10 (62.5) | 51 (40.5) | 45 (42.1) |
| 2 lines | 13 (24.5) | 4 (25.0) | 51 (40.5) | 32 (29.9) |
| ≥3 lines | 12 (22.7) | 2 (12.5) | 24 (19.1) | 30 (28.1) |
| Patients refractory to | ||||
| Lenalidomide | 14 (26.4) | 4 (25.0) | 43 (34.1) | 38 (35.5) |
| IMiD and PI | 6 (11.3) | 2 (12.5) | 29 (23.0) | 25 (23.4) |
| Refractory to last regimen | 25 (47.2) | 5 (31.3) | 64 (50.8) | 68 (63.6) |
| Lenalidomide | 10 (18.9) | 3 (18.8) | 26 (20.6) | 28 (26.2) |
| Bortezomib | 8 (15.1) | 2 (12.5) | 24 (19.0) | 21 (19.6) |
| Cytogenetic risk† | ||||
| High risk | 9 (17.0) | 7 (43.8) | 33 (26.2) | 24 (22.4) |
| Standard risk | 41 (77.4) | 9 (56.3) | 73 (57.9) | 69 (64.5) |
| Unknown or missing | 3 (5.7) | 0 | 20 (15.9) | 14 (13.1) |
| Gain(1q21) present‡ | 24 (45.3) | 7 (43.8) | 51 (40.5) | 45 (42.1) |
Data are presented as No. (%) unless otherwise indicated. CRF, chronic renal failure; eGFR, estimated glomerular filtration rate, IMiD, immunomodulatory drug; LDH, lactate dehydrogenase; MDRD, Modification of Diet in Renal Disease; PI, proteasome inhibitor; ULN, upper limit of normal.
*
Incidence calculated in patients with reported CRF: 165 patients in the Isa-Kd arm and 111 patients in the Kd arm.
†
Cytogenetics by central laboratory: cutoff 50% for del17p, 30% for t(4;14) and t(14;16).
‡
Gain(1q21) is defined as the presence of at least 3 copies with a cutoff of 30%.