Patient demographics and baseline characteristics by evolving MRD status and treatment arm after randomization
| . | MRD− to MRD− . | MRD+ to MRD− . | MRD− to MRD+ . | MRD+ to MRD+ . | ||||
|---|---|---|---|---|---|---|---|---|
| Ixazomib . | Placebo . | Ixazomib . | Placebo . | Ixazomib . | Placebo . | Ixazomib . | Placebo . | |
| Patients, n | 75 | 43 | 42 | 18 | 63 | 48 | 524 | 353 |
| Age at randomization | ||||||||
| <75 y | 69 (92.0) | 39 (90.7) | 39 (92.9) | 15 (83.3) | 58 (92.1) | 45 (93.8) | 400 (76.3) | 270 (76.5) |
| ≥75 y | 6 (8.0) | 4 (9.3) | 3 (7.1) | 3 (16.7) | 5 (7.9) | 3 (6.3) | 124 (23.7) | 83 (23.5) |
| Sex | ||||||||
| Male | 48 (64.0) | 24 (55.8) | 22 (52.4) | 8 (44.4) | 37 (58.7) | 30 (62.5) | 310 (59.2) | 211 (59.8) |
| Female | 27 (36.0) | 19 (44.2) | 20 (47.6) | 10 (55.6) | 26 (41.3) | 18 (37.5) | 214 (40.8) | 142 (40.2) |
| Race | ||||||||
| White | 56 (74.7) | 34 (79.1) | 35 (83.3) | 16 (88.9) | 48 (76.2) | 39 (81.3) | 419 (80.0) | 292 (82.7) |
| Asian | 18 (24.0) | 7 (16.3) | 6 (14.3) | 1 (5.6) | 10 (15.9) | 8 (16.7) | 71 (13.5) | 41 (11.6) |
| Other or not reported | 1 (1.3) | 2 (4.7) | 1 (2.4) | 1 (5.6) | 5 (7.9) | 1 (2.1) | 34 (6.5) | 20 (5.7) |
| Region | ||||||||
| Americas | 2 (2.7) | 2 (4.7) | 3 (7.1) | 1 (5.6) | 5 (7.9) | 1 (2.1) | 42 (8.0) | 25 (7.1) |
| Europe | 54 (72.0) | 34 (79.1) | 31 (73.8) | 17 (94.4) | 46 (73.0) | 38 (79.2) | 394 (75.2) | 273 (77.3) |
| Asia-Pacific | 19 (25.3) | 7 (16.3) | 8 (19.0) | 0 | 12 (19.0) | 9 (18.8) | 88 (16.8) | 55 (15.6) |
| Cytogenetic abnormalities at diagnosis∗ | ||||||||
| High-risk† | 5 (6.7) | 9 (20.9) | 5 (11.9) | 1 (5.6) | 8 (12.7) | 15 (31.3) | 91 (17.4) | 63 (17.8) |
| Corresponding standard-risk | 56 (74.7) | 21 (63.6) | 29 (69.0) | 10 (55.6) | 38 (60.3) | 28 (58.3) | 341 (65.1) | 233 (66.0) |
| Unclassifiable | 14 (18.7) | 13 (39.4) | 8 (19.0) | 7 (38.9) | 17 (27.0) | 5 (10.4) | 92 (17.6) | 57 (16.1) |
| Expanded high-risk‡ | 15 (20.0) | 11 (25.6) | 7 (16.7) | 3 (16.7) | 17 (27.0) | 22 (45.8) | 180 (34.4) | 120 (34.0) |
| Corresponding standard-risk | 33 (44.0) | 16 (48.5) | 22 (52.4) | 7 (38.9) | 26 (41.3) | 17 (35.4) | 186 (35.5) | 130 (36.8) |
| Unclassifiable | 27 (36.0) | 16 (48.5) | 13 (31.0) | 8 (44.4) | 20 (31.7) | 9 (18.8) | 158 (30.2) | 103 (29.2) |
| Preinduction ISS stage | ||||||||
| I or II | 52 (69.3) | 26 (60.5) | 30 (71.4) | 12 (66.7) | 40 (63.5) | 35 (72.9) | 360 (68.7) | 236 (66.9) |
| III | 23 (30.7) | 17 (39.5) | 12 (28.6) | 6 (33.3) | 23 (36.5) | 13 (27.1) | 164 (31.3) | 117 (33.1) |
| PI-exposed§ | 64 (85.3) | 38 (88.4) | 30 (71.4) | 17 (94.4) | 59 (93.7) | 43 (89.6) | 443 (84.5) | 291 (82.4) |
| IMiD-exposed|| | 27 (36.0) | 19 (44.2) | 18 (42.9) | 3 (16.7) | 29 (46.0) | 22 (45.8) | 184 (35.1) | 128 (36.3) |
| Response after transplant/induction | ||||||||
| CR or VGPR | 73 (97.3) | 39 (90.7) | 34 (81.0) | 16 (88.9) | 57 (90.5) | 45 (93.8) | 300 (57.3) | 209 (59.2) |
| PR¶ | 2 (2.7) | 4 (9.3) | 8 (19.0) | 2 (11.1) | 6 (9.5) | 3 (6.3) | 224 (42.7) | 144 (40.8) |
| . | MRD− to MRD− . | MRD+ to MRD− . | MRD− to MRD+ . | MRD+ to MRD+ . | ||||
|---|---|---|---|---|---|---|---|---|
| Ixazomib . | Placebo . | Ixazomib . | Placebo . | Ixazomib . | Placebo . | Ixazomib . | Placebo . | |
| Patients, n | 75 | 43 | 42 | 18 | 63 | 48 | 524 | 353 |
| Age at randomization | ||||||||
| <75 y | 69 (92.0) | 39 (90.7) | 39 (92.9) | 15 (83.3) | 58 (92.1) | 45 (93.8) | 400 (76.3) | 270 (76.5) |
| ≥75 y | 6 (8.0) | 4 (9.3) | 3 (7.1) | 3 (16.7) | 5 (7.9) | 3 (6.3) | 124 (23.7) | 83 (23.5) |
| Sex | ||||||||
| Male | 48 (64.0) | 24 (55.8) | 22 (52.4) | 8 (44.4) | 37 (58.7) | 30 (62.5) | 310 (59.2) | 211 (59.8) |
| Female | 27 (36.0) | 19 (44.2) | 20 (47.6) | 10 (55.6) | 26 (41.3) | 18 (37.5) | 214 (40.8) | 142 (40.2) |
| Race | ||||||||
| White | 56 (74.7) | 34 (79.1) | 35 (83.3) | 16 (88.9) | 48 (76.2) | 39 (81.3) | 419 (80.0) | 292 (82.7) |
| Asian | 18 (24.0) | 7 (16.3) | 6 (14.3) | 1 (5.6) | 10 (15.9) | 8 (16.7) | 71 (13.5) | 41 (11.6) |
| Other or not reported | 1 (1.3) | 2 (4.7) | 1 (2.4) | 1 (5.6) | 5 (7.9) | 1 (2.1) | 34 (6.5) | 20 (5.7) |
| Region | ||||||||
| Americas | 2 (2.7) | 2 (4.7) | 3 (7.1) | 1 (5.6) | 5 (7.9) | 1 (2.1) | 42 (8.0) | 25 (7.1) |
| Europe | 54 (72.0) | 34 (79.1) | 31 (73.8) | 17 (94.4) | 46 (73.0) | 38 (79.2) | 394 (75.2) | 273 (77.3) |
| Asia-Pacific | 19 (25.3) | 7 (16.3) | 8 (19.0) | 0 | 12 (19.0) | 9 (18.8) | 88 (16.8) | 55 (15.6) |
| Cytogenetic abnormalities at diagnosis∗ | ||||||||
| High-risk† | 5 (6.7) | 9 (20.9) | 5 (11.9) | 1 (5.6) | 8 (12.7) | 15 (31.3) | 91 (17.4) | 63 (17.8) |
| Corresponding standard-risk | 56 (74.7) | 21 (63.6) | 29 (69.0) | 10 (55.6) | 38 (60.3) | 28 (58.3) | 341 (65.1) | 233 (66.0) |
| Unclassifiable | 14 (18.7) | 13 (39.4) | 8 (19.0) | 7 (38.9) | 17 (27.0) | 5 (10.4) | 92 (17.6) | 57 (16.1) |
| Expanded high-risk‡ | 15 (20.0) | 11 (25.6) | 7 (16.7) | 3 (16.7) | 17 (27.0) | 22 (45.8) | 180 (34.4) | 120 (34.0) |
| Corresponding standard-risk | 33 (44.0) | 16 (48.5) | 22 (52.4) | 7 (38.9) | 26 (41.3) | 17 (35.4) | 186 (35.5) | 130 (36.8) |
| Unclassifiable | 27 (36.0) | 16 (48.5) | 13 (31.0) | 8 (44.4) | 20 (31.7) | 9 (18.8) | 158 (30.2) | 103 (29.2) |
| Preinduction ISS stage | ||||||||
| I or II | 52 (69.3) | 26 (60.5) | 30 (71.4) | 12 (66.7) | 40 (63.5) | 35 (72.9) | 360 (68.7) | 236 (66.9) |
| III | 23 (30.7) | 17 (39.5) | 12 (28.6) | 6 (33.3) | 23 (36.5) | 13 (27.1) | 164 (31.3) | 117 (33.1) |
| PI-exposed§ | 64 (85.3) | 38 (88.4) | 30 (71.4) | 17 (94.4) | 59 (93.7) | 43 (89.6) | 443 (84.5) | 291 (82.4) |
| IMiD-exposed|| | 27 (36.0) | 19 (44.2) | 18 (42.9) | 3 (16.7) | 29 (46.0) | 22 (45.8) | 184 (35.1) | 128 (36.3) |
| Response after transplant/induction | ||||||||
| CR or VGPR | 73 (97.3) | 39 (90.7) | 34 (81.0) | 16 (88.9) | 57 (90.5) | 45 (93.8) | 300 (57.3) | 209 (59.2) |
| PR¶ | 2 (2.7) | 4 (9.3) | 8 (19.0) | 2 (11.1) | 6 (9.5) | 3 (6.3) | 224 (42.7) | 144 (40.8) |
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.