Response rate, PFS, and OS in the VMPT-VT and VMP arms and by renal cohorts
Measure . | 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) . | |
Response-evaluable, n | 221 | 11 | 52 | 63 | 158 | 235 | 19 | 58 | 77 | 158 |
Response rate, % | 93.2 | 81.8a | 96.2b | 93.7c | 93d | 83 | 68.4 | 81 | 77.9 | 85.4e |
CR rate, % | 39.4 | 36.4f | 42.3g | 41.3h | 38.6i | 25.5 | 15.8 | 25.9 | 23.4 | 26.6j |
Median time to first response, mo | 1.4 | 1.2k | 1.4l | 1.4m | 1.4n | 1.4 | 1.4 | 1.4 | 1.4 | 1.4o |
Median duration of response, mo | NR | 19.8p | NRq | NRr | NRs | 27.9 | 20 | 22 | 21.8 | 28.6t |
Median PFS, mo | NR | 20.9 | NR | NR | NR | 24.6 | 22.5 | 24.2 | 24.2 | 25.1 |
1-year PFS, % | 93 | 80 | 96 | 96 | 92 | 87 | 83 | 89 | 87 | 87 |
2-year PFS, % | 69 | 40 | 73 | 69 | 69 | 55 | 46 | 57 | 54 | 56 |
Median OS, mo | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
1-year OS, % | 92.3 | 75.2 | 94.2 | 90.7 | 93 | 93.8 | 88.9 | 93.1 | 92.1 | 95.3 |
2-year OS, % | 88 | 60.2 | 89.6 | 84.2 | 89.6 | 89.3 | 83.3 | 88.7 | 87.3 | 90.3 |
Measure . | 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) . | |
Response-evaluable, n | 221 | 11 | 52 | 63 | 158 | 235 | 19 | 58 | 77 | 158 |
Response rate, % | 93.2 | 81.8a | 96.2b | 93.7c | 93d | 83 | 68.4 | 81 | 77.9 | 85.4e |
CR rate, % | 39.4 | 36.4f | 42.3g | 41.3h | 38.6i | 25.5 | 15.8 | 25.9 | 23.4 | 26.6j |
Median time to first response, mo | 1.4 | 1.2k | 1.4l | 1.4m | 1.4n | 1.4 | 1.4 | 1.4 | 1.4 | 1.4o |
Median duration of response, mo | NR | 19.8p | NRq | NRr | NRs | 27.9 | 20 | 22 | 21.8 | 28.6t |
Median PFS, mo | NR | 20.9 | NR | NR | NR | 24.6 | 22.5 | 24.2 | 24.2 | 25.1 |
1-year PFS, % | 93 | 80 | 96 | 96 | 92 | 87 | 83 | 89 | 87 | 87 |
2-year PFS, % | 69 | 40 | 73 | 69 | 69 | 55 | 46 | 57 | 54 | 56 |
Median OS, mo | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
1-year OS, % | 92.3 | 75.2 | 94.2 | 90.7 | 93 | 93.8 | 88.9 | 93.1 | 92.1 | 95.3 |
2-year OS, % | 88 | 60.2 | 89.6 | 84.2 | 89.6 | 89.3 | 83.3 | 88.7 | 87.3 | 90.3 |
PFS and OS were analyzed in all 473 patients.
CR indicates complete response; NR, not reached; OS, overall survival; PFS, progression-free survival; VMP, bortezomib-melphalan-prednisone; and VMPT-VT, bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance.
P = .3 for the comparison with VMP patients with eGFR ≤ 30;
P = .026 for the comparison with VMP patients with eGFR 31-50;
P = .015 for the comparison with VMP patients with eGFR ≤ 50;
P = .22 for the comparison with VMPT-VT patients with eGFR31-50 and VMPT-VT patients with eGFR ≤ 30;
P = .16 for the comparison with VMP patients with eGFR 31-50 and VMP patients with eGFR ≤ 30;
P = .2 for the comparison with VMP patients with eGFR ≤ 30;
P = .07 for the comparison with VMP patients with eGFR 31-50;
P = .025 for the comparison with VMP patients with eGFR ≤ 50;
P = .87 for the comparison with VMPT-VT patients with eGFR31–50 and VMPT-VT patients with eGFR ≤ 30;
P = .59 for the comparison with VMP patients with eGFR 31-50 and VMP patients with eGFR ≤ 30;
P = .62 for the comparison with VMP patients with eGFR ≤ 30;
P = .61 for the comparison with VMP patients with eGFR 31-50;
P = .51 for the comparison with VMP patients with eGFR ≤ 50;
P = .89 for the comparison with VMPT-VT patients with eGFR 31-50 and VMPT-VT patients with eGFR ≤ 30;
P = .82 for the comparison with VMP patients with eGFR 31-50 and VMP patients with eGFR ≤ 30;
P = .18 for the comparison with VMP patients with eGFR ≤ 30;
P = .47 for the comparison with VMP patients with eGFR 31-50;
P = .83 for the comparison with VMP patients with eGFR ≤ 50;
P = .41 for the comparison with VMPT-VT patients with eGFR 31-50 and VMPT-VT patients with eGFR < 30; and tP = .57 for the comparison with VMP patients with eGFR 31-50 and VMP patients with eGFR < 30.