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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07391657 | A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) | PHASE3 | RECRUITING | 508 | — | — | Feb 23, 2026 | Aug 12, 2030 | Apr 30, 2026 | 111 | United States, Australia +12 |
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | AZD0120 |
| Arm B | ACTIVE_COMPARATOR | 1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd. |
| Name | Type | Description |
|---|---|---|
| AZD0120 | BIOLOGICAL | CAR-T Cells |
| Daratumumab | DRUG | Daratumumab |
| Carfilzomib | DRUG | Carfilzomib |
| Dexamethasone | DRUG | Dexamethasone |
| Bortezomib | DRUG | Bortezomib |
| Pomalidomide | DRUG | Pomalidomides |
Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (...