No. of patients enrolled | 399 (100%) |
Exclusion during VAD regimen | 101 (25.3%) |
Progressive disease | 39 |
Severe infectious complications | 29 |
Cardiac failure | 9 |
Patient's decision | 8 |
Protocol violation | 5 |
Renal failure | 5 |
Toxic death | 5 |
Suicide | 1 |
No. of patients randomized | 298 (74.7%) |
No. of patients inevaluable for HDT | 16 (4%) |
Progression before ASCT | 7 |
Patient's decision | 4 |
Infectious death before ASCT | 2 |
Protocol violation | 2 |
Suicide | 1 |
No. of patients evaluable | 282 (70.7%) |
Arm A: TBI + HDM140 | 140 |
Arm B: HDM200 | 142 |
No. of patients enrolled | 399 (100%) |
Exclusion during VAD regimen | 101 (25.3%) |
Progressive disease | 39 |
Severe infectious complications | 29 |
Cardiac failure | 9 |
Patient's decision | 8 |
Protocol violation | 5 |
Renal failure | 5 |
Toxic death | 5 |
Suicide | 1 |
No. of patients randomized | 298 (74.7%) |
No. of patients inevaluable for HDT | 16 (4%) |
Progression before ASCT | 7 |
Patient's decision | 4 |
Infectious death before ASCT | 2 |
Protocol violation | 2 |
Suicide | 1 |
No. of patients evaluable | 282 (70.7%) |
Arm A: TBI + HDM140 | 140 |
Arm B: HDM200 | 142 |