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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07409246 | A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM) | PHASE1 | RECRUITING | 127 | — | — | Feb 27, 2026 | Nov 1, 2031 | May 19, 2026 | 9 | United States, Israel +1 |
An AE is 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. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
Clinical laboratory parameters included tests of hematology and chemistry. The investigator will assess the results for clinical significance.
Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-438 Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive ABBV-438 in escalating doses alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose A) | EXPERIMENTAL | Participants will receive ABBV-438 Dose A alone, as part of the 69.5 study duration. |
| Part 2: ABBV-438 Monotherapy Dose Expansion (Dose B) | EXPERIMENTAL | Participants will receive ABBV-438 Dose B alone, as part of the 69.5 study duration. |
| Name | Type | Description |
|---|---|---|
| ABBV-438 | DRUG | Intravenous (IV) |
Inclusion Criteria: * Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria: *...