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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04398485 | A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma | PHASE1 | COMPLETED | 23 | — | — | Jan 20, 2021 | Sep 30, 2024 | Oct 31, 2024 | 6 | United States |
MTD is defined as the maximum dose at which ≤ 1 of 3 evaluable participants experiences a dose-limiting toxicity (DLT) within Cycle 1 and there are 2 of 3 or 2 of 6 evaluable participants in the next higher-dose level experiencing a DLT within Cycle 1. If no dose in the dose-escalation has 2 of 3 or 2 of 6 evaluable participants experiencing a DLT, the highest dose level is considered the MTD
RP2D is chosen based on the dose response and exposure-response analyses of the pooled clinical PK, PD, safety results, and anti-myeloma activity from both Part 1 and Part 2
| Arm | Type | Description |
|---|---|---|
| ION251 | EXPERIMENTAL | In Part 1, the dose escalation phase, increased amounts of ION251 will be administered at multiple time points by intravenous (IV) infusion during 28-day cycles. In Part 2, the determined RP2D of ION251 will be administered at multiple time points by IV infusion. |
| Name | Type | Description |
|---|---|---|
| ION251 | DRUG | ION251 administered by IV infusion |
Inclusion Criteria: 1. Aged ≥ 18 years at the time of informed consent 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Measurable multiple myeloma (MM) 4. In need of systemic treatment for MM and either is refractory to or has failed treatment with, is intolerant to or ...