Response to different treatment phases in the per-protocol population, according to central assessment
| . | VTD (n = 160) . | TD (n = 161) . | P . |
|---|---|---|---|
| After induction therapy | |||
| CR | 36 (22.5%, 16.0-29.0) | 9 (5.6%, 2.0-9.1) | < .0001 |
| CR/nCR | 53 (33.1%, 25.8-40.4) | 22 (13.7%, 8.3-19.0) | < .0001 |
| VGPR or better | 100 (62.5%, 55.0-70.0) | 50 (31.1%, 23.9-38.2) | < .0001 |
| PR or better | 154 (96.2%, 93.3-99.2) | 140 (87.0%, 81.7-92.1) | .003 |
| MR or SD | 6 (3.7%, 0.8-6.7) | 21 (13.0%, 7.8-18.2) | .003 |
| After first ASCT | |||
| CR | 70 (43.8%, 36.1-51.4) | 49 (30.4%, 23.3-37.5) | .014 |
| CR/nCR | 91 (56.9%, 49.2-64.5) | 66 (41.0%, 33.4-48.6) | .004 |
| VGPR or better | 131 (81.9%, 75.9-87.8) | 117 (72.7%, 65.8-79.6) | .049 |
| PR or better | 156 (97.5%, 95.1-100) | 156 (96.9%, 94.2-99.6) | .742 |
| MR or SD | 4 (2.5%, 0.1-0.5) | 5 (3.1%, 0.04-5.8) | .742 |
| After second ASCT | |||
| CR | 78 (48.7%, 41.0-56.5) | 65 (40.4%, 32.8-47.9) | .131 |
| CR/nCR | 101 (63.1%, 55.6-70.6) | 88 (54.7%, 47.0-62.3) | .123 |
| VGPR or better | 138 (86.2%, 80.9-91.6) | 131 (81.4%, 75.3-87.4) | .235 |
| PR or better | 157 (98.1%, 96.0-100) | 157 (97.5%, 95.1-99.9) | .709 |
| MR or SD | 3 (1.9%, 0.0-4.0) | 4 (2.5%, 0.1-4.9) | .709 |
| After consolidation therapy | |||
| CR | 97 (60.6%, 53.0-68.2) | 75 (46.6%, 38.9-54.3) | .012 |
| CR/nCR | 117 (73.1%, 66.2-80.0) | 98 (60.9%, 53.3-68.4) | .020 |
| VGPR or better | 147 (91.9%, 87.6-96.1) | 142 (88.2%, 83.2-93.2) | .272 |
| PR or better | 156 (97.5%, 95.1-99.9) | 160 (99.4%, 98.2-100) | .174 |
| MR or SD | 1 (0.6%, 0-1.8) | 1 (0.6%, 0-1.8) | .996 |
| PD | 3 (1.9%, 0-4.0) | .081 |
| . | VTD (n = 160) . | TD (n = 161) . | P . |
|---|---|---|---|
| After induction therapy | |||
| CR | 36 (22.5%, 16.0-29.0) | 9 (5.6%, 2.0-9.1) | < .0001 |
| CR/nCR | 53 (33.1%, 25.8-40.4) | 22 (13.7%, 8.3-19.0) | < .0001 |
| VGPR or better | 100 (62.5%, 55.0-70.0) | 50 (31.1%, 23.9-38.2) | < .0001 |
| PR or better | 154 (96.2%, 93.3-99.2) | 140 (87.0%, 81.7-92.1) | .003 |
| MR or SD | 6 (3.7%, 0.8-6.7) | 21 (13.0%, 7.8-18.2) | .003 |
| After first ASCT | |||
| CR | 70 (43.8%, 36.1-51.4) | 49 (30.4%, 23.3-37.5) | .014 |
| CR/nCR | 91 (56.9%, 49.2-64.5) | 66 (41.0%, 33.4-48.6) | .004 |
| VGPR or better | 131 (81.9%, 75.9-87.8) | 117 (72.7%, 65.8-79.6) | .049 |
| PR or better | 156 (97.5%, 95.1-100) | 156 (96.9%, 94.2-99.6) | .742 |
| MR or SD | 4 (2.5%, 0.1-0.5) | 5 (3.1%, 0.04-5.8) | .742 |
| After second ASCT | |||
| CR | 78 (48.7%, 41.0-56.5) | 65 (40.4%, 32.8-47.9) | .131 |
| CR/nCR | 101 (63.1%, 55.6-70.6) | 88 (54.7%, 47.0-62.3) | .123 |
| VGPR or better | 138 (86.2%, 80.9-91.6) | 131 (81.4%, 75.3-87.4) | .235 |
| PR or better | 157 (98.1%, 96.0-100) | 157 (97.5%, 95.1-99.9) | .709 |
| MR or SD | 3 (1.9%, 0.0-4.0) | 4 (2.5%, 0.1-4.9) | .709 |
| After consolidation therapy | |||
| CR | 97 (60.6%, 53.0-68.2) | 75 (46.6%, 38.9-54.3) | .012 |
| CR/nCR | 117 (73.1%, 66.2-80.0) | 98 (60.9%, 53.3-68.4) | .020 |
| VGPR or better | 147 (91.9%, 87.6-96.1) | 142 (88.2%, 83.2-93.2) | .272 |
| PR or better | 156 (97.5%, 95.1-99.9) | 160 (99.4%, 98.2-100) | .174 |
| MR or SD | 1 (0.6%, 0-1.8) | 1 (0.6%, 0-1.8) | .996 |
| PD | 3 (1.9%, 0-4.0) | .081 |
Data are number (%, 95% CI).
VTD indicates bortezomib with thalidomide plus dexamethasone; TD, thalidomide plus dexamethasone; CR, complete response; nCR, near-complete response; VGPR, very good partial response; PR, partial response; MR, minimal response; SD, stable disease; and PD, progressive disease.