TABLE 1.
Patient baseline characteristics by age group: ≥70 and <70 years, ITT population
| ≥70 Years (n = 86) | <70 Years (n = 216) | |||
|---|---|---|---|---|
| Isa‐Kd (n = 52) | Kd (n = 34) | Isa‐Kd (n = 127) | Kd (n = 89) | |
| Median age, years (range) | 73 (70–86) | 74 (70–90) | 61 (37–69) | 61 (33–69) |
| ISS stage at study entry, n (%) | ||||
| Stage I | 25 (48.1) | 16 (47.1) | 64 (50.4) | 55 (61.8) |
| Stage II | 20 (38.5) | 11 (32.4) | 43 (33.9) | 20 (22.5) |
| Stage III | 7 (13.5) | 6 (17.6) | 19 (15.0) | 14 (15.7) |
| Unknown | 0 | 1 (2.9) | 1 (0.8) | 0 |
| R‐ISS stage at study entry, n (%) | ||||
| Stage I | 14 (26.9) | 8 (23.5) | 31 (24.4) | 25 (28.1) |
| Stage II | 32 (61.5) | 22 (64.7) | 78 (61.4) | 48 (53.9) |
| Stage III | 5 (9.6) | 2 (5.9) | 11 (8.7) | 6 (6.7) |
| Not classified | 1 (1.9) | 2 (5.9) | 7 (5.5) | 10 (11.2) |
| Cytogenetic risk, a n (%) | ||||
| High risk | 11 (21.2) | 9 (26.5) | 31 (24.4) | 22 (24.7) |
| Standard risk | 33 (63.5) | 22 (64.7) | 81 (63.8) | 56 (62.9) |
| Unknown | 8 (15.4) | 3 (8.8) | 15 (11.8) | 11 (12.4) |
| Prior lines of therapy | ||||
| Median (range) | 2 (1–4) | 2 (1–4) | 2 (1–4) | 2 (1–3) |
| 1 line, n (%) | 24 (46.2) | 11 (32.4) | 55 (43.3) | 44 (49.4) |
| ≥2 lines, n (%) | 28 (53.8) | 23 (67.6) | 72 (56.7) | 45 (50.6) |
| Patients refractory to, n (%) | ||||
| Lenalidomide | 18 (34.6) | 18 (52.9) | 39 (30.7) | 24 (27.0) |
| IMiD and PI | 9 (17.3) | 10 (29.4) | 26 (20.5) | 17 (19.1) |
| Baseline eGFR, b n/n (%) | ||||
| ≥60 ml/min/1.73 m2 | 32/48 (66.7) | 24/31 (77.4) | 88/115 (76.5) | 68/79 (86.1) |
| <60 ml/min/1.73 m2 | 16/48 (33.3%) | 7/31 (22.6%) | 27/115 (23.5) | 11/79 (13.9) |
Abbreviations: d, dexamethasone; eGFR, estimated glomerular filtration rate; IMiD, immunomodulatory drug; Isa, isatuximab; ISS, International Staging System; ITT, intent‐to‐treat; K, carfilzomib; PI, proteasome inhibitor; R‐ISS, revised International Staging System.
a
High risk was defined as del(17p), t(4; 14), or t(14; 16) by fluorescence in situ hybridization. Cytogenetic risk was assessed by a central laboratory with a cut‐off of 50% for del(17p), and 30% for t(4; 14) and t(14; 16).
b
Baseline eGFR by the modification of diet in renal disease (MDRD) equation.