Patients’ baseline and disease characteristics
| Characteristic . | ASPIRE . | ENDEAVOR . | FOCUS . | |||
|---|---|---|---|---|---|---|
| Carfilzomib (KRd) . | Control (Rd) . | Carfilzomib (Kd) . | Control (Vd) . | Carfilzomib (carfilzomib) . | Control (BSC) . | |
| n | 392 | 389 | 463 | 456 | 157 | 153 |
| Age, median (range), y | 64.0 (38-87) | 65.0 (31-91) | 65.0 (35-89) | 65.0 (30-88) | 63.0 (32-85) | 66.0 (43-81) |
| Age ≥75 y, n (%) | 43 (11.0) | 50 (12.9) | 77 (16.6) | 65 (14.3) | 25 (15.9) | 23 (15.0) |
| Sex, male/female, % | 53.8/46.2 | 58.6/41.4 | 51.8/48.2 | 48.9/51.1 | 52.2/47.8 | 60.1/39.9 |
| Eastern Cooperative Oncology Group performance status, n (%) | ||||||
| 0 | 164 (41.8) | 174 (44.7) | 220 (47.5) | 228 (50.0) | 49 (31.2) | 30 (19.6) |
| 1 | 189 (48.2) | 181 (46.5) | 211 (45.6) | 199 (43.6) | 78 (49.7) | 89 (58.2) |
| 2 | 39 (9.9) | 34 (8.7) | 32 (6.9) | 29 (6.4) | 29 (18.5) | 33 (21.6) |
| International Staging System, n (%) | ||||||
| I | 167 (42.6) | 152 (39.1) | 204 (44.1) | 200 (43.9) | 29 (18.5) | 31 (20.3) |
| II-III | 217 (55.4) | 230 (59.1) | 259 (55.9) | 256 (56.1) | 125 (79.6) | 120 (78.4) |
| Serum β2 microglobulin, median (range), mg/L | 3.5 (1.3-13.0) | 3.6 (1.5-31.7) | 3.6 (1.4-24.2) | 3.7 (1.2-31.6) | 5.3 (2.0-35.7) | 5.9 (1.8-49.6) |
| Creatinine clearance, n (%), mL/min | ||||||
| <30 | 0 | 1 (0.3) | 28 (6.0) | 28 (6.1) | 16 (10.2) | 13 (8.5) |
| 30 to <50 | 24 (6.1) | 30 (7.7) | 57 (12.3) | 69 (15.1) | 29 (18.5) | 40 (26.1) |
| 50 to <80 | 170 (43.4) | 150 (38.6) | 186 (40.2) | 174 (38.2) | 64 (40.8) | 58 (37.9) |
| ≥80 | 197 (50.3) | 203 (52.2) | 192 (41.5) | 185 (40.6) | 48 (30.6) | 41 (26.8) |
| Medical history, n (%) | ||||||
| History of hypertension | 194 (49.5) | 178 (45.8) | 233 (50.3) | 221 (48.5) | 60 (38.2) | 75 (49.0) |
| History of cardiac failure | 17 (4.3) | 5 (1.3) | 14 (3.0) | 13 (2.9) | 6 (3.8) | 10 (6.5) |
| History of cardiac arrhythmias | 44 (11.2) | 38 (9.8) | 27 (5.8) | 33 (7.2) | 18 (11.5) | 17 (11.1) |
| Characteristic . | ASPIRE . | ENDEAVOR . | FOCUS . | |||
|---|---|---|---|---|---|---|
| Carfilzomib (KRd) . | Control (Rd) . | Carfilzomib (Kd) . | Control (Vd) . | Carfilzomib (carfilzomib) . | Control (BSC) . | |
| n | 392 | 389 | 463 | 456 | 157 | 153 |
| Age, median (range), y | 64.0 (38-87) | 65.0 (31-91) | 65.0 (35-89) | 65.0 (30-88) | 63.0 (32-85) | 66.0 (43-81) |
| Age ≥75 y, n (%) | 43 (11.0) | 50 (12.9) | 77 (16.6) | 65 (14.3) | 25 (15.9) | 23 (15.0) |
| Sex, male/female, % | 53.8/46.2 | 58.6/41.4 | 51.8/48.2 | 48.9/51.1 | 52.2/47.8 | 60.1/39.9 |
| Eastern Cooperative Oncology Group performance status, n (%) | ||||||
| 0 | 164 (41.8) | 174 (44.7) | 220 (47.5) | 228 (50.0) | 49 (31.2) | 30 (19.6) |
| 1 | 189 (48.2) | 181 (46.5) | 211 (45.6) | 199 (43.6) | 78 (49.7) | 89 (58.2) |
| 2 | 39 (9.9) | 34 (8.7) | 32 (6.9) | 29 (6.4) | 29 (18.5) | 33 (21.6) |
| International Staging System, n (%) | ||||||
| I | 167 (42.6) | 152 (39.1) | 204 (44.1) | 200 (43.9) | 29 (18.5) | 31 (20.3) |
| II-III | 217 (55.4) | 230 (59.1) | 259 (55.9) | 256 (56.1) | 125 (79.6) | 120 (78.4) |
| Serum β2 microglobulin, median (range), mg/L | 3.5 (1.3-13.0) | 3.6 (1.5-31.7) | 3.6 (1.4-24.2) | 3.7 (1.2-31.6) | 5.3 (2.0-35.7) | 5.9 (1.8-49.6) |
| Creatinine clearance, n (%), mL/min | ||||||
| <30 | 0 | 1 (0.3) | 28 (6.0) | 28 (6.1) | 16 (10.2) | 13 (8.5) |
| 30 to <50 | 24 (6.1) | 30 (7.7) | 57 (12.3) | 69 (15.1) | 29 (18.5) | 40 (26.1) |
| 50 to <80 | 170 (43.4) | 150 (38.6) | 186 (40.2) | 174 (38.2) | 64 (40.8) | 58 (37.9) |
| ≥80 | 197 (50.3) | 203 (52.2) | 192 (41.5) | 185 (40.6) | 48 (30.6) | 41 (26.8) |
| Medical history, n (%) | ||||||
| History of hypertension | 194 (49.5) | 178 (45.8) | 233 (50.3) | 221 (48.5) | 60 (38.2) | 75 (49.0) |
| History of cardiac failure | 17 (4.3) | 5 (1.3) | 14 (3.0) | 13 (2.9) | 6 (3.8) | 10 (6.5) |
| History of cardiac arrhythmias | 44 (11.2) | 38 (9.8) | 27 (5.8) | 33 (7.2) | 18 (11.5) | 17 (11.1) |
Cardiac failure and hypertension events are listed as standardized MedDRA query, narrow scope and ischemic heart disease event is listed as standardized MedDRA query, broad scope.