Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Surzetoclax · 1 trial · 1 indication
DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Substudy 1: Dose Escalation Surzetoclax Combination | EXPERIMENTAL | Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 1: Dose Optimization & Selection ABBV-453 Combination | EXPERIMENTAL | Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration. |
| Substudy 1: Dose Optimization & Selection Control | ACTIVE_COMPARATOR | Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration. |
| Substudy 2: Dose Escalation ABBV-453 Monotherapy | EXPERIMENTAL | Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Escalation Surzetoclax + Etentamig | EXPERIMENTAL | Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Dose A Combination | EXPERIMENTAL | Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Dose B Combination | EXPERIMENTAL | Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration. |
| Substudy 3: Dose Optimization Etentamig Monotherapy | EXPERIMENTAL | Participants will receive etentamig, as part of the total 4.5 year study duration. |
| Name | Type | Description |
|---|---|---|
| Surzetoclax | DRUG | Oral |
| Daratumumab | DRUG | Subcutaneous (SC) Injection |
| Dexamethasone | DRUG | Oral |
| Pomalidomide | DRUG | Oral |
| Etentamig | DRUG | Intravenous Infusion |
Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria. * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: ...
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