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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05308654 | A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets | PHASE1 | ACTIVE NOT_RECRUITING | 34 | — | — | May 17, 2022 | Dec 1, 2025 | Aug 14, 2025 | 21 | United States, Australia +2 |
ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) + very good partial response (VGPR) + complete response (CR) + stringent complete response (sCR) as assessed by investigators per adapted IMWG criteria for relapsed or refractory (R/R) multiple myeloma (MM).
| Arm | Type | Description |
|---|---|---|
| Part 1: Monotherapy Dose Escalation | EXPERIMENTAL | Participants with relapsed or refractory (R/R) multiple myeloma (MM) will receive escalating doses of ABBV-453, until the maximum tolerated dose (MTD) is determined. |
| Part 2: Arm 1 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with dexamethasone in 28-day cycles. |
| Part 2: Arm 2 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with daratumumab and dexamethasone in 28-day cycles. |
| Part 2: Arm 3 | EXPERIMENTAL | Participants will receive continuous doses of ABBV-453 in combination with daratumumab, lenalidomide, and dexamethasone in 28-day cycles. |
| Japan Cohort | EXPERIMENTAL | Participants with R/R MM will receive escalating doses of ABBV-453, until the MTD is determined. |
| Name | Type | Description |
|---|---|---|
| ABBV-453 | DRUG | Oral; Tablet |
| Dexamethasone | DRUG | Oral Tablet |
| Daratumumab | DRUG | Subcutaneous Injection |
| Lenalidomide | DRUG | Oral Capsule |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \<= 1. * Laboratory values meeting the criteria outlined in the protocol. * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. * Has measurable diseas...