Table 1.
Patient demographics and baseline disease characteristics
| Once-weekly KRd56 (N = 228) | Twice-weekly KRd27 (N = 226) | |
|---|---|---|
| Age, n (%) | ||
| Median (range), y | 64.0 (40-83) | 65.0 (40-85) |
| 18 to <65 | 116 (50.9) | 107 (47.3) |
| 65 to <75 | 92 (40.4) | 102 (45.1) |
| ≥75 | 20 (8.8) | 17 (7.5) |
| Sex, n (%) | ||
| Male | 110 (48.2) | 126 (55.8) |
| Female | 118 (51.8) | 100 (44.2) |
| Race, n (%) | ||
| White | 209 (91.7) | 209 (92.5) |
| Asian | 12 (5.3) | 9 (4.0) |
| Black or African American | 1 (0.4) | 1 (0.4) |
| Other | 6 (2.6) | 7 (3.1) |
| ECOG performance status, n (%) | ||
| 0-1 (0 or 1) | 219 (96.1) | 215 (95.1) |
| 2 | 9 (3.9) | 11 (4.9) |
| ISS stage, n (%) | ||
| Stage I or II | 209 (91.7) | 209 (92.5) |
| Stage III | 19 (8.3) | 17 (7.5) |
| Cytogenetic risk by FISH, n (%)∗ | ||
| High risk | 44 (28.2) | 40 (27.4) |
| t(4; 14) | 25 (16.0) | 23 (15.8) |
| t(14; 16) | 3 (1.9) | 1 (0.7) |
| Deletion 17p | 21 (13.5) | 19 (13.0) |
| Standard risk† | 112 (71.8) | 106 (72.6) |
| Creatinine clearance, n (%) | ||
| Median (range) | 84.0 (28.8-220.2) | 84.6 (42.6-208.2) |
| <30 mL/min | 2 (0.9) | 0 (0.0) |
| ≥30 to <50 mL/min | 11 (4.8) | 4 (1.8) |
| ≥50 to <80 mL/min | 84 (36.8) | 95 (42.0) |
| ≥80 mL/min | 131 (57.5) | 127 (56.2) |
| β2 microglobulin, n (%) | ||
| Median (range) | 3.0 (1.4-21.6) | 2.9 (1.4-19.9) |
| <3.5 mg/L | 153 (67.1) | 150 (66.4) |
| ≥3.5 and <5.5 mg/L | 56 (24.6) | 59 (26.1) |
| ≥5.5 mg/L | 19 (8.3) | 17 (7.5) |
| Previous transplant, n (%) | 153 (67.1) | 148 (65.5) |
| Previous regimens, n (%) | ||
| 1 | 157 (68.9) | 154 (68.1) |
| 2 | 49 (21.5) | 43 (19.0) |
| >2 | 22 (9.6) | 29 (12.8) |
| Previous treatment, n (%) | ||
| Bortezomib | 210 (92.1) | 211 (93.4) |
| PI | 214 (93.9) | 218 (96.5) |
| Lenalidomide | 85 (37.3) | 79 (35.0) |
| Anti-CD38 therapy | 21 (9.2) | 17 (7.5) |
| Refractory to prior treatment‡, n (%) | ||
| Any previous bortezomib | 19 (8.3) | 16 (7.1) |
| Any previous PI | 22 (9.6) | 21 (9.3) |
| Any previous lenalidomide | 39 (17.1) | 40 (17.7) |
| Anti-CD38 therapy | 14 (6.1) | 11 (4.9) |
| Last prior line of therapy | 58 (25.4) | 52 (23.0) |
ECOG, Eastern Cooperative Oncology Group; FISH, fluorescence in-situ hybridization; ISS, International Staging System.
Cytogenetic risk data were missing for 72 patients (31.6%) in the once-weekly group and for 80 patients (35.4%) in the twice-weekly group. The % cytogenetic risk is calculated from patients with available data.
Patients with normal cytogenetics or chromosomal abnormalities other than t(4;14), t(14;16), and/or deletion 17p were included in the standard-risk group.
Patients were classified as refractory to prior treatment if the best response to prior treatment was stable or progressive disease, disease progression was the specific reason for treatment discontinuation, or disease progression occurred within 60 days of treatment discontinuation.