Patient demographics and baseline disease characteristics
| . | Ixazomib-Rd (N = 351) . | Placebo-Rd (N = 354) . |
|---|---|---|
| Median age (range), y | 73 (48-90) | 74 (48-88) |
| Age categories, y, n (%) | ||
| <65 | 11 (3.1) | 8 (2.3) |
| 65 to <75 | 189 (53.8) | 190 (53.7) |
| 75 to <85 | 134 (38.2) | 145 (41.0) |
| ≥85 | 17 (4.8) | 11 (3.1) |
| Sex, n (%) | ||
| Male | 172 (49.0) | 182 (51.4) |
| Female | 179 (51.0) | 172 (48.6) |
| Race, n (%) | ||
| White | 291 (82.9) | 285 (80.5) |
| Asian | 44 (12.5) | 52 (14.7) |
| Black or African American | 11 (3.1) | 13 (3.7) |
| Other | 5 (1.4) | 4 (1.1) |
| ECOG performance status, n (%) | ||
| 0 | 110 (31.3) | 105 (29.7) |
| 1 | 183 (52.1) | 198 (55.9) |
| 2 | 58 (16.5) | 51 (14.4) |
| ISS stage at study entry, n (%) | ||
| I | 171 (48.7) | 153 (43.2) |
| II | 123 (35.0) | 142 (40.1) |
| III | 56 (16.0) | 59 (16.7) |
| Missing | 1 (0.3) | 0 |
| Revised-ISS stage at study entry, n (%) | ||
| I | 107 (30.5) | 96 (27.1) |
| II | 222 (63.2) | 241 (68.1) |
| III | 21 (6.0) | 17 (4.8) |
| Missing | 1 (0.3) | 0 |
| BPI-SF worst pain rating at screening, n (%) | ||
| <4 | 162 (46.2) | 164 (46.3) |
| ≥4 | 189 (53.8) | 190 (53.7) |
| Cytogenetics, n (%)* | ||
| High risk [t(4;14), t(14;16), del(17p)] | 60 (17.1) | 63 (17.8) |
| Corresponding standard risk | 231 (65.8) | 234 (66.1) |
| Unclassifiable for high risk | 60 (17.1) | 57 (16.1) |
| Expanded high risk [t(4;14), t(14;16), del(17p), amp(1q21)] | 134 (38.2) | 146 (41.2) |
| Corresponding standard risk | 155 (44.2) | 139 (39.3) |
| Unclassifiable for expanded high risk | 62 (17.7) | 69 (19.5) |
| CrCl, n (%) | ||
| ≤60 mL/min | 148 (42.2) | 150 (42.4) |
| >60 mL/min | 203 (57.8) | 204 (57.6) |
| Elevated LDH, n (%) | 43 (12.3) | 32 (9.0) |
| Extramedullary disease at study entry, % | 11 (3.1) | 11 (3.1) |
| . | Ixazomib-Rd (N = 351) . | Placebo-Rd (N = 354) . |
|---|---|---|
| Median age (range), y | 73 (48-90) | 74 (48-88) |
| Age categories, y, n (%) | ||
| <65 | 11 (3.1) | 8 (2.3) |
| 65 to <75 | 189 (53.8) | 190 (53.7) |
| 75 to <85 | 134 (38.2) | 145 (41.0) |
| ≥85 | 17 (4.8) | 11 (3.1) |
| Sex, n (%) | ||
| Male | 172 (49.0) | 182 (51.4) |
| Female | 179 (51.0) | 172 (48.6) |
| Race, n (%) | ||
| White | 291 (82.9) | 285 (80.5) |
| Asian | 44 (12.5) | 52 (14.7) |
| Black or African American | 11 (3.1) | 13 (3.7) |
| Other | 5 (1.4) | 4 (1.1) |
| ECOG performance status, n (%) | ||
| 0 | 110 (31.3) | 105 (29.7) |
| 1 | 183 (52.1) | 198 (55.9) |
| 2 | 58 (16.5) | 51 (14.4) |
| ISS stage at study entry, n (%) | ||
| I | 171 (48.7) | 153 (43.2) |
| II | 123 (35.0) | 142 (40.1) |
| III | 56 (16.0) | 59 (16.7) |
| Missing | 1 (0.3) | 0 |
| Revised-ISS stage at study entry, n (%) | ||
| I | 107 (30.5) | 96 (27.1) |
| II | 222 (63.2) | 241 (68.1) |
| III | 21 (6.0) | 17 (4.8) |
| Missing | 1 (0.3) | 0 |
| BPI-SF worst pain rating at screening, n (%) | ||
| <4 | 162 (46.2) | 164 (46.3) |
| ≥4 | 189 (53.8) | 190 (53.7) |
| Cytogenetics, n (%)* | ||
| High risk [t(4;14), t(14;16), del(17p)] | 60 (17.1) | 63 (17.8) |
| Corresponding standard risk | 231 (65.8) | 234 (66.1) |
| Unclassifiable for high risk | 60 (17.1) | 57 (16.1) |
| Expanded high risk [t(4;14), t(14;16), del(17p), amp(1q21)] | 134 (38.2) | 146 (41.2) |
| Corresponding standard risk | 155 (44.2) | 139 (39.3) |
| Unclassifiable for expanded high risk | 62 (17.7) | 69 (19.5) |
| CrCl, n (%) | ||
| ≤60 mL/min | 148 (42.2) | 150 (42.4) |
| >60 mL/min | 203 (57.8) | 204 (57.6) |
| Elevated LDH, n (%) | 43 (12.3) | 32 (9.0) |
| Extramedullary disease at study entry, % | 11 (3.1) | 11 (3.1) |
ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in situ hybridization; LDH, lactate dehydrogenase.
In accordance with the protocol, the cutoff values for defining the presence of high-risk cytogenetic abnormalities were established by the central diagnostic laboratory on the basis of the false positive rates (or technical cutoff values) of the FISH probes that were used. These cutoff points were 5% positive cells for del(17p), 3% positive cells for t(4;14) and t(14;16), and 20% positive cells for amp(1q21).