Baseline patient characteristics
| Characteristic . | KdD (n = 312) . | Kd (n = 154) . |
|---|---|---|
| Median (range) age, years | 64.0 (57-70) | 64.5 (59-71) |
| ≤64, n (%) | 163 (52) | 77 (50) |
| 65–74, n (%) | 121 (39) | 55 (38) |
| ≥75, n (%) | 28 (9) | 22 (14) |
| Baseline ECOG PS, n (%) | ||
| 0-1 | 295 (95) | 147 (95) |
| 2 | 15 (5) | 7 (5) |
| ISS stage at screening, n (%) | ||
| I | 147 (47) | 79 (51) |
| II | 103 (33) | 48 (31) |
| III | 61 (20) | 27 (18) |
| Unknown | 1 (0) | 0 |
| Cytogenetic risk group based on FISH,∗ n (%) | ||
| High | 48 (15) | 26 (17) |
| Standard | 108 (35) | 56 (36) |
| Unknown | 156 (50) | 72 (47) |
| Number of prior therapies, n (%) | ||
| 1 | 144 (46) | 70 (45) |
| 2-3 | 168 (54) | 84 (55) |
| Prior therapies, n (%) | ||
| Bortezomib | 287 (92) | 134 (87) |
| Lenalidomide | 123 (39) | 74 (48) |
| Pomalidomide | 14 (4) | 10 (6) |
| Refractory† to bortezomib and lenalidomide, n (%) | 37 (12) | 18 (12) |
| Refractory to prior bortezomib, n (%) | 88 (28) | 47 (31) |
| As last line of prior therapy | 47 (15) | 31 (20) |
| Refractory to prior lenalidomide, n (%) | 99 (32) | 55 (36) |
| As last line of prior therapy | 74 (24) | 38 (25) |
| After 1 prior line of therapy | 19 (6) | 6 (4) |
| After 2–3 prior lines of therapy | 80 (26) | 49 (32) |
| Refractory to pomalidomide, n (%) | 10 (3) | 9 (6) |
| Characteristic . | KdD (n = 312) . | Kd (n = 154) . |
|---|---|---|
| Median (range) age, years | 64.0 (57-70) | 64.5 (59-71) |
| ≤64, n (%) | 163 (52) | 77 (50) |
| 65–74, n (%) | 121 (39) | 55 (38) |
| ≥75, n (%) | 28 (9) | 22 (14) |
| Baseline ECOG PS, n (%) | ||
| 0-1 | 295 (95) | 147 (95) |
| 2 | 15 (5) | 7 (5) |
| ISS stage at screening, n (%) | ||
| I | 147 (47) | 79 (51) |
| II | 103 (33) | 48 (31) |
| III | 61 (20) | 27 (18) |
| Unknown | 1 (0) | 0 |
| Cytogenetic risk group based on FISH,∗ n (%) | ||
| High | 48 (15) | 26 (17) |
| Standard | 108 (35) | 56 (36) |
| Unknown | 156 (50) | 72 (47) |
| Number of prior therapies, n (%) | ||
| 1 | 144 (46) | 70 (45) |
| 2-3 | 168 (54) | 84 (55) |
| Prior therapies, n (%) | ||
| Bortezomib | 287 (92) | 134 (87) |
| Lenalidomide | 123 (39) | 74 (48) |
| Pomalidomide | 14 (4) | 10 (6) |
| Refractory† to bortezomib and lenalidomide, n (%) | 37 (12) | 18 (12) |
| Refractory to prior bortezomib, n (%) | 88 (28) | 47 (31) |
| As last line of prior therapy | 47 (15) | 31 (20) |
| Refractory to prior lenalidomide, n (%) | 99 (32) | 55 (36) |
| As last line of prior therapy | 74 (24) | 38 (25) |
| After 1 prior line of therapy | 19 (6) | 6 (4) |
| After 2–3 prior lines of therapy | 80 (26) | 49 (32) |
| Refractory to pomalidomide, n (%) | 10 (3) | 9 (6) |
ECOG PS, Eastern Cooperative Oncology Group performance status; ISS, international staging system.
FISH analysis was conducted by the central laboratory. The high-risk group consisted of patients with the genetic subtypes t(4;14), t(14;16), or deletion 17p. The standard-risk group consisted of patients without t(4; 14), t(14; 16), and deletion 17p. The unknown risk group consisted of patients with FISH results that failed or were canceled.
Patients were considered refractory to a drug received in previous regimens if any of the following criteria were met: best response to any regimen containing the drug was stable disease or progressive disease; reason for which the drug was stopped was progression in any regimen; and date of relapse or progression was after start date and within 60 days after stop date of the drug in any regimen.