Best confirmed responses, pain responses, and MRD evaluation in the ITT population
| . | Ixazomib-Rd (N = 351), n (%) (exact 95% CI) . | Placebo-Rd (N = 354), n (%) (exact 95% CI) . | OR (95% CI) . | P . |
|---|---|---|---|---|
| Confirmed best response | ||||
| CR including sCR | 90 (25.6) (21.2-30.5) | 50 (14.1) (10.7-18.2) | 2.10 (1.43-3.09) | <.001 |
| VGPR | 131 (37.3) (32.2-42.6) | 119 (33.6) (28.7-38.8) | ||
| CR + VGPR (including sCR) | 221 (63.0) (57.7-68.0) | 169 (47.7) (42.4-53.1) | 1.87 (1.38-2.53) | <.001 |
| PR | 67 (19.1) (15.1-23.6) | 113 (31.9) (27.1-37.1) | ||
| ORR (CR + PR + VGPR [including sCR]) | 288 (82.1) (77.6-85.9) | 282 (79.7) (75.1-83.7) | 1.16 (0.79-1.70) | .436 |
| SD | 31 (8.8) (6.1-12.3) | 37 (10.5) (7.5-14.1) | ||
| PD | 4 (1.1) (0.3-2.9) | 14 (4.0) (2.2-6.5) | ||
| Not evaluable | 28 (8.0) (5.4-11.3) | 21 (5.9) (3.7-8.9) | ||
| Evaluation of MRD by flow cytometry (sensitivity 10−5) | ||||
| Patients evaluated for MRD status | 101 (28.8) | 62 (17.5) | ||
| Patients who were MRD-negative, n/N (%) | 53/101 (52.5) | 24/62 (38.7) | ||
| Pain response | ||||
| BPI-SF worst pain score ≥4 at baseline* | 190 (54.1) | 195 (55.1) | ||
| Pain response,† n/N (%) | 96/190 (50.5) (43.2-57.8) | 100/195 (51.3) (44.0-58.5) | 0.98 (0.66-1.46) | .920 |
| . | Ixazomib-Rd (N = 351), n (%) (exact 95% CI) . | Placebo-Rd (N = 354), n (%) (exact 95% CI) . | OR (95% CI) . | P . |
|---|---|---|---|---|
| Confirmed best response | ||||
| CR including sCR | 90 (25.6) (21.2-30.5) | 50 (14.1) (10.7-18.2) | 2.10 (1.43-3.09) | <.001 |
| VGPR | 131 (37.3) (32.2-42.6) | 119 (33.6) (28.7-38.8) | ||
| CR + VGPR (including sCR) | 221 (63.0) (57.7-68.0) | 169 (47.7) (42.4-53.1) | 1.87 (1.38-2.53) | <.001 |
| PR | 67 (19.1) (15.1-23.6) | 113 (31.9) (27.1-37.1) | ||
| ORR (CR + PR + VGPR [including sCR]) | 288 (82.1) (77.6-85.9) | 282 (79.7) (75.1-83.7) | 1.16 (0.79-1.70) | .436 |
| SD | 31 (8.8) (6.1-12.3) | 37 (10.5) (7.5-14.1) | ||
| PD | 4 (1.1) (0.3-2.9) | 14 (4.0) (2.2-6.5) | ||
| Not evaluable | 28 (8.0) (5.4-11.3) | 21 (5.9) (3.7-8.9) | ||
| Evaluation of MRD by flow cytometry (sensitivity 10−5) | ||||
| Patients evaluated for MRD status | 101 (28.8) | 62 (17.5) | ||
| Patients who were MRD-negative, n/N (%) | 53/101 (52.5) | 24/62 (38.7) | ||
| Pain response | ||||
| BPI-SF worst pain score ≥4 at baseline* | 190 (54.1) | 195 (55.1) | ||
| Pain response,† n/N (%) | 96/190 (50.5) (43.2-57.8) | 100/195 (51.3) (44.0-58.5) | 0.98 (0.66-1.46) | .920 |
PR, partial response; sCR, stringent complete response; SD, stable disease.
BPI-SF baseline data differ from data at screening used for stratification, as the BPI is a patient-reported tool in which the patient reports the pain they are currently experiencing and have experienced within the previous 24 h.
Pain response is defined as the occurrence of at least a 30% reduction from baseline in BPI-SF worst pain score over the last 24 h without an increase in analgesic use for 2 consecutive measurements ≥28 d apart.