Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04263480 | Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia | PHASE2 | ACTIVE NOT_RECRUITING | 99 | — | — | Aug 18, 2021 | Aug 1, 2028 | Apr 4, 2025 | 20 | Austria, Germany +1 |
Primary endpoint is the rate of CR or VGPR 12 months after the start of treatment using the response criteria updated at the Sixth IWWM (CR/VGPR).
| Arm | Type | Description |
|---|---|---|
| Arm A: Carfilzomib + Ibrutinib | EXPERIMENTAL | Patients will be treated with Ibrutinib until evidence of progressive disease or no longer tolerated. Patients will receive in addition Carfilzomib for two years. |
| Arm B: Ibrutinib | ACTIVE_COMPARATOR | Patients will be treated with Ibrutinib until evidence of progressive disease or no longer tolerated. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib + Ibrutinib | DRUG | Carfilzomib: Cycle 1, day 1: 20 mg/m² i.v. Cycle 1, day 8, day 15: 70 mg/m² i.v. Cycle 2 - 12, day 1, day 8, day 15: 70 mg/m² i.v. Cycle 13 - 24, day 1, day 15: 70 mg/m² i.v. Ibrutinib: 420 mg p.o daily until disease progression or non-tolerable toxicities |
| Ibrutinib | DRUG | Ibrutinib: 420 mg p.o daily until disease progression or non-tolerable toxicities |
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in this study: * Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Histopathology has to occur before randomization within the la...