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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03283917 | Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis | PHASE1 | ACTIVE NOT_RECRUITING | 21 | — | — | Feb 7, 2018 | May 18, 2027 | Feb 27, 2026 | 1 | United States |
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.
| Arm | Type | Description |
|---|---|---|
| Treatment (daratumumab, ixazomib, dexamethasone) | EXPERIMENTAL | Participants receive daratumumab IV over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity. |
| Name | Type | Description |
|---|---|---|
| Daratumumab | BIOLOGICAL | Given IV |
| Dexamethasone | DRUG | Given IV or PO |
| Ixazomib | DRUG | Given PO |
Inclusion Criteria: * Diagnosis of primary systemic AL amyloidosis of tissue as determined by: a. Congo red staining of tissue showing apple green birefringence AND b. Clonal plasma cell disorder as determined by: i. Immunohistochemistry, in situ hybridization (ISH) or flow cytometry demonstrating ...