drugset / Trial / NCT05451771
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
Timeline
- Start
- 2022-10-26
- Primary completion
- 2027-09
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Comparator | Daratumumab | Monoclonal antibody | 1800 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 10 mg | Oral |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Comparator | Ixazomib | Unknown | 4 mg | — |
| Comparator | Pomalidomide | Other / unclassified | 2 mg | — |
| Subject | Venetoclax | Small molecule | 200 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |