Main clinical and laboratory characteristics of patients distributed by VMPT-VT and VMP arms and by renal cohorts
| Characteristics . | VMPT-VT arm, estimated glomerular filtration rate . | VMP arm, estimated glomerular filtration rate . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total (n = 232) . | ≤ 30 (n = 14) . | 31-50 (n = 56) . | ≤ 50 (n = 70) . | > 50 (n = 162) . | Total (n = 241) . | ≤ 30 (n = 19) . | 31-50 (n = 60) . | ≤ 50 (n = 79) . | > 50 (n = 162) . | |
| Median age, y | 71 | 74.5 | 73.5 | 74 | 70 | 71 | 72 | 74 | 72 | 71 |
| Male, % | 51.3 | 42.9 | 39.3 | 40 | 56.2 | 46.9 | 31.6 | 46.7 | 43 | 48.8 |
| KPS ≤ 70%, % | 30.6 | 35.7 | 33.9 | 34.3 | 29 | 26.6 | 31.6 | 31.7 | 31.6 | 24.1 |
| ISS stage III, % | 23.8 | 90 | 34.7 | 44.1 | 14.6 | 29.1 | 73.3 | 48.9 | 55 | 17.1 |
| Median β2M, mg/L | 3.7 | 10.3 | 4.6 | 5.1 | 3.3 | 4 | 7.2 | 5.4 | 5.97 | 3.5 |
| Median albumin, g/dL | 3.75 | 3.5 | 3.6 | 3.6 | 3.87 | 3.8 | 4 | 3.7 | 3.8 | 3.75 |
| Chromosome abnormalities* | ||||||||||
| del13, % | 53.6 | 83.3 | 53.1 | 59 | 50.8 | 46.6 | 42.9 | 46.3 | 45.5 | 47.1 |
| t(4;14), % | 16.8 | 25 | 22.4 | 23 | 13.6 | 12.6 | 7.1 | 9.8 | 9.1 | 14.3 |
| t(11;14), % | 16.2 | 16.7 | 10.2 | 11.5 | 18.6 | 11.5 | 7.1 | 9.8 | 9.1 | 12.6 |
| t(14;16), % | 5 | 8.3 | 8.2 | 8.2 | 3.4 | 3.4 | 0 | 0 | 0 | 5 |
| del17, % | 17.3 | 16.7 | 8.2 | 9.8 | 21.2 | 11.5 | 21.4 | 7.3 | 10.9 | 11.8 |
| Bortezomib schedule | ||||||||||
| Once weekly, % | 74.6 | 85.7 | 71.4 | 74.3 | 74.7 | 76.3 | 89.5 | 71.7 | 75.9 | 76.5 |
| Twice weekly, % | 25.4 | 14.3 | 28.6 | 25.7 | 25.3 | 23.7 | 10.5 | 28.3 | 24.1 | 23.5 |
| Characteristics . | VMPT-VT arm, estimated glomerular filtration rate . | VMP arm, estimated glomerular filtration rate . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total (n = 232) . | ≤ 30 (n = 14) . | 31-50 (n = 56) . | ≤ 50 (n = 70) . | > 50 (n = 162) . | Total (n = 241) . | ≤ 30 (n = 19) . | 31-50 (n = 60) . | ≤ 50 (n = 79) . | > 50 (n = 162) . | |
| Median age, y | 71 | 74.5 | 73.5 | 74 | 70 | 71 | 72 | 74 | 72 | 71 |
| Male, % | 51.3 | 42.9 | 39.3 | 40 | 56.2 | 46.9 | 31.6 | 46.7 | 43 | 48.8 |
| KPS ≤ 70%, % | 30.6 | 35.7 | 33.9 | 34.3 | 29 | 26.6 | 31.6 | 31.7 | 31.6 | 24.1 |
| ISS stage III, % | 23.8 | 90 | 34.7 | 44.1 | 14.6 | 29.1 | 73.3 | 48.9 | 55 | 17.1 |
| Median β2M, mg/L | 3.7 | 10.3 | 4.6 | 5.1 | 3.3 | 4 | 7.2 | 5.4 | 5.97 | 3.5 |
| Median albumin, g/dL | 3.75 | 3.5 | 3.6 | 3.6 | 3.87 | 3.8 | 4 | 3.7 | 3.8 | 3.75 |
| Chromosome abnormalities* | ||||||||||
| del13, % | 53.6 | 83.3 | 53.1 | 59 | 50.8 | 46.6 | 42.9 | 46.3 | 45.5 | 47.1 |
| t(4;14), % | 16.8 | 25 | 22.4 | 23 | 13.6 | 12.6 | 7.1 | 9.8 | 9.1 | 14.3 |
| t(11;14), % | 16.2 | 16.7 | 10.2 | 11.5 | 18.6 | 11.5 | 7.1 | 9.8 | 9.1 | 12.6 |
| t(14;16), % | 5 | 8.3 | 8.2 | 8.2 | 3.4 | 3.4 | 0 | 0 | 0 | 5 |
| del17, % | 17.3 | 16.7 | 8.2 | 9.8 | 21.2 | 11.5 | 21.4 | 7.3 | 10.9 | 11.8 |
| Bortezomib schedule | ||||||||||
| Once weekly, % | 74.6 | 85.7 | 71.4 | 74.3 | 74.7 | 76.3 | 89.5 | 71.7 | 75.9 | 76.5 |
| Twice weekly, % | 25.4 | 14.3 | 28.6 | 25.7 | 25.3 | 23.7 | 10.5 | 28.3 | 24.1 | 23.5 |
β2M indicates β2microglobulin; del, deletion; ISS, International Staging System; KPS, Karnofsky performance status; t, translocation; VMP, bortezomib-melphalan-prednisone; and VMPT-VT, bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance.
Data available in 179 of 232 cases of the VMPT-VT arm and in 174 of 241 cases of the VMP arm.