Patient demographics and baseline characteristics by MRD status and treatment arm at randomization
| . | MRD− . | Known MRD+ . | ||||
|---|---|---|---|---|---|---|
| Ixazomib (n = 820) . | Placebo (n = 542) . | All (n = 1362) . | Ixazomib (n = 820) . | Placebo (n = 542) . | All (n = 1362) . | |
| Patients, n | 161 | 101 | 262 | 606 | 412 | 1018 |
| Age at randomization | ||||||
| <75 y | 145 (90.1) | 91 (90.1) | 236 (90.1) | 470 (77.6) | 314 (76.2) | 784 (77.0) |
| ≥75 y | 16 (9.9) | 10 (9.9) | 26 (9.9) | 136 (22.4) | 98 (23.8) | 234 (23.0) |
| Sex | ||||||
| Male | 94 (58.4) | 60 (59.4) | 154 (58.8) | 352 (58.1) | 243 (59.0) | 595 (58.4) |
| Female | 67 (41.6) | 41 (40.6) | 108 (41.2) | 254 (41.9) | 169 (41.0) | 423 (41.6) |
| Race | ||||||
| White | 124 (77.0) | 80 (79.2) | 204 (77.9) | 486 (80.2) | 339 (82.3) | 825 (81.0) |
| Asian | 30 (18.6) | 17 (16.8) | 47 (17.9) | 83 (13.7) | 51 (12.4) | 134 (13.2) |
| Other or not reported | 7 (4.3) | 4 (4.0) | 11 (4.2) | 37 (6.1) | 22 (5.3) | 59 (5.8) |
| Region | ||||||
| Americas | 9 (5.6) | 3 (3.0) | 12 (4.6) | 46 (7.6) | 29 (7.0) | 75 (7.4) |
| Europe | 119 (73.9) | 79 (78.2) | 198 (75.6) | 457 (75.4) | 317 (76.9) | 774 (76.0) |
| Asia-Pacific | 33 (20.5) | 19 (18.8) | 52 (19.8) | 103 (17.0) | 66 (16.0) | 169 (16.6) |
| Cytogenetic abnormalities at diagnosis∗ | ||||||
| High-risk† | 21 (13.0) | 27 (26.7) | 48 (18.3) | 104 (17.2) | 70 (17.0) | 174 (17.1) |
| Corresponding standard-risk | 103 (64.0) | 55 (54.5) | 158 (60.3) | 395 (65.2) | 265 (64.3) | 660 (64.8) |
| Unclassifiable | 37 (23.0) | 19 (18.8) | 56 (21.4) | 107 (17.7) | 77 (18.7) | 184 (18.1) |
| Expanded high-risk‡ | 42 (26.1) | 37 (36.6) | 79 (30.2) | 204 (33.7) | 135 (32.8) | 339 (33.3) |
| Corresponding standard-risk | 65 (40.4) | 35 (34.7) | 100 (38.2) | 223 (36.8) | 149 (36.2) | 372 (36.5) |
| Unclassifiable | 54 (33.5) | 29 (28.7) | 83 (31.7) | 179 (29.5) | 128 (31.1) | 307 (30.2) |
| Preinduction ISS stage | ||||||
| I or II | 108 (67.1) | 69 (68.3) | 177 (67.6) | 415 (68.5) | 277 (67.2) | 692 (68.0) |
| III | 53 (32.9) | 32 (31.7) | 85 (32.4) | 191 (31.5) | 135 (32.8) | 326 (32.0) |
| PI-exposed§ | 145 (90.1) | 90 (89.1) | 235 (89.7) | 511 (84.3) | 342 (83.0) | 853 (83.8) |
| IMiD-exposed|| | 64 (39.8) | 44 (43.6) | 108 (41.2) | 208 (34.3) | 144 (35.0) | 352 (34.6) |
| Response after transplant/induction | ||||||
| CR or VGPR | 153 (95.0) | 93 (92.1) | 246 (93.9) | 370 (61.1) | 262 (63.6) | 632 (62.1) |
| PR¶ | 8 (5.0) | 8 (7.9) | 16 (6.1) | 236 (38.9) | 150 (36.4) | 386 (37.9) |
| . | MRD− . | Known MRD+ . | ||||
|---|---|---|---|---|---|---|
| Ixazomib (n = 820) . | Placebo (n = 542) . | All (n = 1362) . | Ixazomib (n = 820) . | Placebo (n = 542) . | All (n = 1362) . | |
| Patients, n | 161 | 101 | 262 | 606 | 412 | 1018 |
| Age at randomization | ||||||
| <75 y | 145 (90.1) | 91 (90.1) | 236 (90.1) | 470 (77.6) | 314 (76.2) | 784 (77.0) |
| ≥75 y | 16 (9.9) | 10 (9.9) | 26 (9.9) | 136 (22.4) | 98 (23.8) | 234 (23.0) |
| Sex | ||||||
| Male | 94 (58.4) | 60 (59.4) | 154 (58.8) | 352 (58.1) | 243 (59.0) | 595 (58.4) |
| Female | 67 (41.6) | 41 (40.6) | 108 (41.2) | 254 (41.9) | 169 (41.0) | 423 (41.6) |
| Race | ||||||
| White | 124 (77.0) | 80 (79.2) | 204 (77.9) | 486 (80.2) | 339 (82.3) | 825 (81.0) |
| Asian | 30 (18.6) | 17 (16.8) | 47 (17.9) | 83 (13.7) | 51 (12.4) | 134 (13.2) |
| Other or not reported | 7 (4.3) | 4 (4.0) | 11 (4.2) | 37 (6.1) | 22 (5.3) | 59 (5.8) |
| Region | ||||||
| Americas | 9 (5.6) | 3 (3.0) | 12 (4.6) | 46 (7.6) | 29 (7.0) | 75 (7.4) |
| Europe | 119 (73.9) | 79 (78.2) | 198 (75.6) | 457 (75.4) | 317 (76.9) | 774 (76.0) |
| Asia-Pacific | 33 (20.5) | 19 (18.8) | 52 (19.8) | 103 (17.0) | 66 (16.0) | 169 (16.6) |
| Cytogenetic abnormalities at diagnosis∗ | ||||||
| High-risk† | 21 (13.0) | 27 (26.7) | 48 (18.3) | 104 (17.2) | 70 (17.0) | 174 (17.1) |
| Corresponding standard-risk | 103 (64.0) | 55 (54.5) | 158 (60.3) | 395 (65.2) | 265 (64.3) | 660 (64.8) |
| Unclassifiable | 37 (23.0) | 19 (18.8) | 56 (21.4) | 107 (17.7) | 77 (18.7) | 184 (18.1) |
| Expanded high-risk‡ | 42 (26.1) | 37 (36.6) | 79 (30.2) | 204 (33.7) | 135 (32.8) | 339 (33.3) |
| Corresponding standard-risk | 65 (40.4) | 35 (34.7) | 100 (38.2) | 223 (36.8) | 149 (36.2) | 372 (36.5) |
| Unclassifiable | 54 (33.5) | 29 (28.7) | 83 (31.7) | 179 (29.5) | 128 (31.1) | 307 (30.2) |
| Preinduction ISS stage | ||||||
| I or II | 108 (67.1) | 69 (68.3) | 177 (67.6) | 415 (68.5) | 277 (67.2) | 692 (68.0) |
| III | 53 (32.9) | 32 (31.7) | 85 (32.4) | 191 (31.5) | 135 (32.8) | 326 (32.0) |
| PI-exposed§ | 145 (90.1) | 90 (89.1) | 235 (89.7) | 511 (84.3) | 342 (83.0) | 853 (83.8) |
| IMiD-exposed|| | 64 (39.8) | 44 (43.6) | 108 (41.2) | 208 (34.3) | 144 (35.0) | 352 (34.6) |
| Response after transplant/induction | ||||||
| CR or VGPR | 153 (95.0) | 93 (92.1) | 246 (93.9) | 370 (61.1) | 262 (63.6) | 632 (62.1) |
| PR¶ | 8 (5.0) | 8 (7.9) | 16 (6.1) | 236 (38.9) | 150 (36.4) | 386 (37.9) |
Values are presented as n (%).
Cytogenetic assessments were performed locally and interpreted centrally by a board-certified hematopathologist.
Defined as the presence of any of the following 3 individual abnormalities: del(17), t(4;14), t(14;16).
Defined as the presence of any of the following 4 individual abnormalities: del(17), t(4;14), t(14;16), amp1q.
Patients who had a prior PI during induction with or without an IMiD; not additive.
Patients who had a prior IMiD during induction with or without a PI; not additive.
Patients with PR based on M-protein levels from flow cytometry assay output; patients with PR were not included in the final MRD analyses.