Table 1.
Baseline characteristics of Japanese patients with relapsed or refractory multiple myeloma randomized to bortezomib + dexamethasone (BD) or thalidomide + dexamethasone (TD) treatment arms (n = 44)
| BD (n = 22) | TD (n = 22) | |
|---|---|---|
| Age, years; median (range) | 65 (44‐77) | 66.5 (57‐76) |
| Sex | ||
| Male | 10 | 13 |
| Female | 12 | 9 |
| Performance status (ECOG) | ||
| 0 | 10 | 9 |
| 1 | 9 | 12 |
| 2 | 1 | 1 |
| 3 due to bone lesions | 2 | 0 |
| ISS disease stage at initial diagnosis | ||
| I | 5 | 6 |
| II | 12 | 11 |
| III | 4 | 5 |
| Not reported | 1 | 0 |
| ISS disease stage at randomization | ||
| I | 16 | 18 |
| II | 4 | 3 |
| III | 2 | 1 |
| Disease status | ||
| Primary refractory | 0 | 1 |
| Relapsed or relapsed and refractory | 22 | 21 |
| Time from diagnosis to randomization, months; median (range) | 27.6 (9.3‐117.4) | 27.8 (3.6‐75.5) |
| M‐protein class | ||
| IgG | 14 | 9 |
| IgA | 4 | 7 |
| Light chains only | 4 | 6 |
| G‐banded karyotype | ||
| Normal | 14 | 15 |
| Abnormal | 7 | 7 |
| NA | 1 | 0 |
| Chromosomal translocation‐associated gene expression | ||
| CCND1 | 3 | 6 |
| FGFR3 | 4 | 7 |
| c‐MAF | 2 | 1 |
| Not expressed | 9 | 5 |
| NA* | 4 | 3 |
| Number of prior regimens | ||
| 1 | 17 | 17 |
| 2 | 2 | 5 |
| 3 | 3 | 0 |
| Prior therapies | ||
| Upfront ASCT | 12 | 12 |
| MP‐like regimen | 10 | 8 |
| VAD‐like regimen | 13 | 11 |
| Lenalidomide | 0 | 3 |
ASCT, autologous stem cell transplantation; ISS, International Staging System; MP, melphalan + prednisolone; NA, not assessed; VAD, vincristine, doxorubicin + dexamethasone.