drugset / Trial / NCT06629818
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
NaSingle-groupOpen-labelTreatment
Summary
Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.
Timeline
- Start
- 2024-10-15
- Primary completion
- 2026-10-14
- Completion
- 2026-10-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 10 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |