Table 3.
Best response with bortezomib treatment in patients with relapsed/refractory multiple myeloma (efficacy analysis set)
| Overall best response, n (% of total) | CR | nCR | PR | MR | Stable disease | PD | Total |
|---|---|---|---|---|---|---|---|
| 118 (24.7) | 56 (11.7) | 202 (42.3) | 49 (10.3) | 35 (7.3) | 18 (3.8) | 478 (100) | |
| Best response in different subgroups, n (% of total) | |||||||
| Lines of treatment | |||||||
| 2 | 35 (25.9) | 16 (11.9) | 50 (37.0) | 18 (13.3) | 9 (6.7) | 7 (5.2) | 135 (100) |
| 3 | 54 (23.0) | 38 (16.2) | 97 (41.3) | 23 (9.8) | 17 (7.2) | 6 (2.6) | 235 (100) |
| ≥4 | 28 (28.0) | 2 (2.0) | 53 (53.0) | 8 (8.0) | 6 (6.0) | 3 (3.0) | 100 (100) |
| Othersa | 1 (25.0) | 0 | 1 (25.0) | 0 | 2 (50.0) | 0 | 4 (100) |
| Durie–Salmon staging | |||||||
| I | 7 (29.2) | 2 (8.3) | 9 (37.5) | 2 (8.3) | 2 (8.3) | 2 (8.3) | 24 (100) |
| IIA | 26 (36.1) | 8 (11.1) | 22 (30.6) | 11 (15.3) | 5 (6.9) | 0 (0.0) | 72 (100) |
| IIB | 3 (17.6) | 2 (11.8) | 10 (58.8) | 0 (0.0) | 1 (5.9) | 1 (5.9) | 17 (100) |
| IIIA | 56 (24.9) | 26 (11.6) | 103 (45.8) | 21 (9.3) | 10 (4.4) | 9 (4.0) | 225 (100) |
| IIIB | 18 (18.9) | 14 (14.7) | 38 (40.0) | 12 (12.6) | 9 (9.5) | 4 (4.2) | 95 (100) |
| Average dose of bortezomib | |||||||
| <1.0 mg/m2 | 10 (16.4) | 7 (11.5) | 26 (42.6) | 9 (14.8) | 5 (8.2) | 4 (6.6) | 61 (100) |
| 1.0 to <1.3 mg/m2 | 72 (24.7) | 36 (12.4) | 127 (43.6) | 27 (9.3) | 19 (6.5) | 10 (3.4) | 291 (100) |
| ≥1.3 mg/m2 | 35 (29.2) | 12 (10.0) | 47 (39.2) | 12 (10.0) | 10 (8.3) | 4 (3.3) | 120 (100) |
| Best response by cycle | |||||||
| 1 | 43 (9.9) | 31 (7.1) | 217 (50.0) | 66 (15.2) | 53 (12.2) | 24 (5.5) | 434 (100) |
| 2 | 56 (16.2) | 43 (12.5) | 155 (44.9) | 33 (9.6) | 27 (7.8) | 31 (9.0) | 345 (100) |
| 3 | 47 (21.3) | 30 (13.6) | 92 (41.6) | 22 (10.0) | 18 (8.1) | 12 (5.4) | 221 (100) |
| 4 | 54 (31.4) | 18 (10.5) | 71 (41.3) | 12 (7.0) | 8 (4.7) | 9 (5.2) | 172 (100) |
| 5 | 32 (30.2) | 11 (10.4) | 43 (40.6) | 5 (4.7) | 7 (6.6) | 8 (7.6) | 106 (100) |
| 6 | 24 (35.3) | 2 (2.9) | 30 (44.1) | 3 (4.4) | 4 (5.9) | 5 (7.4) | 68 (100) |
| 7 | 14 (33.3) | 3 (7.1) | 15 (35.7) | 3 (7.1) | 3 (7.1) | 4 (9.5) | 42 (100) |
| 8 | 14 (45.2) | 0 (0) | 12 (38.7) | 1 (3.2) | 2 (6.5) | 2 (6.5) | 31 (100) |
Efficacy analysis set: included patients who received at least 1 dose of bortezomib (with 1 or more prior treatments)
CR complete response, MR minimal response, nCR near complete response (complete response with positive immunofixation), PD progressive disease, PR partial response
aConsolidation therapy (treatment after autologous stem cell transplant) or missing