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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03539744 | A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma. | PHASE3 | ACTIVE NOT_RECRUITING | 265 | — | — | Oct 22, 2018 | Nov 1, 2027 | Jun 19, 2025 | 180 | United States, Australia +18 |
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm 1 VenDex | EXPERIMENTAL | Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle. |
| Arm 2 PomDex | ACTIVE_COMPARATOR | Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Pomalidomide | DRUG | capsule, oral |
| Dexamethasone | DRUG | oral, locally available form |
| Venetoclax | DRUG | tablet; oral |
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. * Measurable disease at screening as defined per protocol. * Has received at least 2 prior lines of therapy as described in the protocol. * Has had documented d...