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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02278315 | Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 31 | — | — | Feb 1, 2015 | Aug 10, 2022 | Feb 22, 2023 | 4 | United States |
DLT will be assessed by physical examination, vital signs, ECG, and laboratory values
| Arm | Type | Description |
|---|---|---|
| Single | EXPERIMENTAL | I-131-CLR1404 with or without concurrent dexamethasone |
| Name | Type | Description |
|---|---|---|
| I-131-CLR1404 | DRUG | Single IV dose of I-131-CLR1404, increased/decreased by cohort |
| dexamethasone | DRUG | 40 mg dexamethasone orally once weekly for up to 12 weeks |
Inclusion Criteria: * Histologically or cytologically confirmed multiple myeloma * Prior treatment with or intolerance to proteasome inhibitor and immunomodulator * Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement * Progressive disease defin...