Baseline characteristics of the intention-to-treat population
| Characteristic . | Carfilzomib group (n = 478) . | Bortezomib group (n = 477) . | Total (N = 955) . |
|---|---|---|---|
| Age | |||
| Median, y | 72 | 72 | 72 |
| Range, y | 42-89 | 43-91 | 42-91 |
| Distribution, no. of patients (%) | |||
| <65 | 16 (3.3) | 35 (7.3) | 51 (5.3) |
| 65-74 | 311 (65.1) | 297 (62.3) | 608 (63.7) |
| ≥75 | 151 (31.6) | 145 (30.4) | 296 (31.0) |
| Sex, no. (%) | |||
| Male | 243 (50.8) | 239 (50.1) | 482 (50.5) |
| Female | 235 (49.2) | 238 (49.9) | 473 (49.5) |
| International Staging System stage, no. (%) | |||
| Stage 1 | 84 (17.6) | 94 (19.7) | 178 (18.6) |
| Stage 2 | 211 (44.1) | 203 (42.6) | 414 (43.4) |
| Stage 3 | 182 (38.1) | 180 (37.7) | 362 (37.9) |
| Unknown | 1 (0.2) | 0 | 1 (0.1) |
| Cytogenetics, no. (%)* | |||
| High risk | 54 (11.3) | 67 (14.0) | 121 (12.7) |
| Standard risk | 320 (66.9) | 324 (67.9) | 644 (67.4) |
| Unknown | 104 (21.8) | 86 (18.0) | 190 (19.9) |
| Race, no. (%) | |||
| White | 329 (68.8) | 339 (71.1) | 668 (69.9) |
| Asian | 123 (25.7) | 121 (25.4) | 244 (25.5) |
| American Indian or Alaska Native | 1 (0.2) | 2 (0.4) | 3 (0.3) |
| Other | 6 (1.3) | 3 (0.6) | 9 (0.9) |
| Not reported | 19 (4.0) | 12 (2.5) | 31 (3.2) |
| Serum β2microglobulin, mg/L, no. (%) | |||
| <2.5 | 40 (8.4) | 39 (8.2) | 79 (8.3) |
| 2.5 to <5.5 | 256 (53.6) | 256 (53.7) | 512 (53.6) |
| ≥5.5 | 182 (38.1) | 182 (38.2) | 364 (38.1) |
| Characteristic . | Carfilzomib group (n = 478) . | Bortezomib group (n = 477) . | Total (N = 955) . |
|---|---|---|---|
| Age | |||
| Median, y | 72 | 72 | 72 |
| Range, y | 42-89 | 43-91 | 42-91 |
| Distribution, no. of patients (%) | |||
| <65 | 16 (3.3) | 35 (7.3) | 51 (5.3) |
| 65-74 | 311 (65.1) | 297 (62.3) | 608 (63.7) |
| ≥75 | 151 (31.6) | 145 (30.4) | 296 (31.0) |
| Sex, no. (%) | |||
| Male | 243 (50.8) | 239 (50.1) | 482 (50.5) |
| Female | 235 (49.2) | 238 (49.9) | 473 (49.5) |
| International Staging System stage, no. (%) | |||
| Stage 1 | 84 (17.6) | 94 (19.7) | 178 (18.6) |
| Stage 2 | 211 (44.1) | 203 (42.6) | 414 (43.4) |
| Stage 3 | 182 (38.1) | 180 (37.7) | 362 (37.9) |
| Unknown | 1 (0.2) | 0 | 1 (0.1) |
| Cytogenetics, no. (%)* | |||
| High risk | 54 (11.3) | 67 (14.0) | 121 (12.7) |
| Standard risk | 320 (66.9) | 324 (67.9) | 644 (67.4) |
| Unknown | 104 (21.8) | 86 (18.0) | 190 (19.9) |
| Race, no. (%) | |||
| White | 329 (68.8) | 339 (71.1) | 668 (69.9) |
| Asian | 123 (25.7) | 121 (25.4) | 244 (25.5) |
| American Indian or Alaska Native | 1 (0.2) | 2 (0.4) | 3 (0.3) |
| Other | 6 (1.3) | 3 (0.6) | 9 (0.9) |
| Not reported | 19 (4.0) | 12 (2.5) | 31 (3.2) |
| Serum β2microglobulin, mg/L, no. (%) | |||
| <2.5 | 40 (8.4) | 39 (8.2) | 79 (8.3) |
| 2.5 to <5.5 | 256 (53.6) | 256 (53.7) | 512 (53.6) |
| ≥5.5 | 182 (38.1) | 182 (38.2) | 364 (38.1) |
The high-risk group consisted of patients with the genetic subtypes t(4;14), t(14;16), or deletion 17p in ≥60% of plasma cells. The standard-risk group consisted of patients without t(4;14), t(14;16), and <60% of plasma cells with deletion 17p. The unknown risk group consisted of patients with fluorescence in situ hybridization result not done, failed, or quantity was not sufficient.