Summary of responses and improvements (per protocol)
| Response . | After induction therapy . | After ASCT . | After consolidation . | Best response . | ||||
|---|---|---|---|---|---|---|---|---|
| Bor-HDM (n = 154) . | HDM (n = 146) . | Bor-HDM (n = 152*) . | HDM (n = 144) . | Bor-HDM (n = 141) . | HDM (n = 138) . | Bor-HDM (n = 152*) . | HDM (n = 146) . | |
| sCR | 9 (5.8) | 4 (2.7) | 16 (10.5) | 19 (13.2) | 27 (19.1) | 31 (22.5) | 45 (29.6) | 45 (30.8) |
| CR | 5 (3.2) | 7 (4.8) | 18 (11.8) | 12 (8.3) | 16 (11.3) | 13 (9.4) | 24 (15.8) | 17 (11.6) |
| VGPR | 76 (49.4) | 72 (49.3) | 88 (57.9) | 76 (52.8) | 74 (52.5) | 67 (48.6) | 61 (40.1) | 59 (40.4) |
| Partial response | 55 (35.7) | 54 (37.0) | 29 (19.1) | 31 (21.5) | 22 (15.6) | 22 (15.9) | 21 (13.8) | 20 (13.7) |
| Stable disease | 9 (5.8) | 9 (6.2) | 0 | 4 (2.8) | 0 | 3 (2.2) | 0 | 3 (2.1) |
| PD | 0 | 0 | 1 (0.7) | 2 (1.4) | 2 (1.4) | 2 (1.4) | 1 (0.7)† | 2 (1.4)† |
| Negative MRD‡ | 14/67 (20.9) | 15/67 (22.4) | 31/75 (41.3) | 26/66 (39.4) | 34/72 (47.2) | 32/67 (47.8) | 47/90 (52.2) | 47/92 (51.1) |
| sCR/CR | 14 (9.0) | 11 (7.5) | 34 (22.3) | 31 (21.5) | 43 (30.4) | 44 (31.9) | 69 (45.4) | 62 (42.5) |
| sCR/CR + VGPR | 90 (58.4) | 83 (57.5) | 122 (80.3) | 107 (74.3) | 117 (83.0) | 111 (80.4) | 130 (85.5) | 121 (82.9) |
| PR or less to sCR/CR | – | – | 0/63 | 2/61 | 0/28 | 0/28 | – | – |
| VGPR to sCR/CR | – | – | 20/75 | 18/72 | 12/81 | 16/74 | – | – |
| Response . | After induction therapy . | After ASCT . | After consolidation . | Best response . | ||||
|---|---|---|---|---|---|---|---|---|
| Bor-HDM (n = 154) . | HDM (n = 146) . | Bor-HDM (n = 152*) . | HDM (n = 144) . | Bor-HDM (n = 141) . | HDM (n = 138) . | Bor-HDM (n = 152*) . | HDM (n = 146) . | |
| sCR | 9 (5.8) | 4 (2.7) | 16 (10.5) | 19 (13.2) | 27 (19.1) | 31 (22.5) | 45 (29.6) | 45 (30.8) |
| CR | 5 (3.2) | 7 (4.8) | 18 (11.8) | 12 (8.3) | 16 (11.3) | 13 (9.4) | 24 (15.8) | 17 (11.6) |
| VGPR | 76 (49.4) | 72 (49.3) | 88 (57.9) | 76 (52.8) | 74 (52.5) | 67 (48.6) | 61 (40.1) | 59 (40.4) |
| Partial response | 55 (35.7) | 54 (37.0) | 29 (19.1) | 31 (21.5) | 22 (15.6) | 22 (15.9) | 21 (13.8) | 20 (13.7) |
| Stable disease | 9 (5.8) | 9 (6.2) | 0 | 4 (2.8) | 0 | 3 (2.2) | 0 | 3 (2.1) |
| PD | 0 | 0 | 1 (0.7) | 2 (1.4) | 2 (1.4) | 2 (1.4) | 1 (0.7)† | 2 (1.4)† |
| Negative MRD‡ | 14/67 (20.9) | 15/67 (22.4) | 31/75 (41.3) | 26/66 (39.4) | 34/72 (47.2) | 32/67 (47.8) | 47/90 (52.2) | 47/92 (51.1) |
| sCR/CR | 14 (9.0) | 11 (7.5) | 34 (22.3) | 31 (21.5) | 43 (30.4) | 44 (31.9) | 69 (45.4) | 62 (42.5) |
| sCR/CR + VGPR | 90 (58.4) | 83 (57.5) | 122 (80.3) | 107 (74.3) | 117 (83.0) | 111 (80.4) | 130 (85.5) | 121 (82.9) |
| PR or less to sCR/CR | – | – | 0/63 | 2/61 | 0/28 | 0/28 | – | – |
| VGPR to sCR/CR | – | – | 20/75 | 18/72 | 12/81 | 16/74 | – | – |
Data are expressed as no. (%) or n/N (%) unless otherwise indicated. PD, progressive disease; PR, partial response.
One patient died of flu infection during transplant and 1 patient withdrew consent.
These 3 patients experienced disease progression after randomization and did not undergo HDT.
Sensitivity of 10−5.