drugset / Trial / NCT04973137
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2025-04-02
- Completion
- 2025-06-20
Publications
- Palladini G, Liedtke M, Zago W, Dolan P, Kinney GG, Gertz MA. The mechanism of action, pharmacological characteristics, and clinical utility of the amyloid depleter birtamimab for the potential treatment of AL amyloidosis. Leuk Lymphoma. 2024 Aug;65(8):1068-1078. doi: 10.1080/10428194.2024.2337803. Epub 2024 Apr 11.
- Gertz MA, Cohen AD, Comenzo RL, Kastritis E, Landau HJ, Libby EN, Liedtke M, Sanchorawala V, Schonland S, Wechalekar A, Zonder JA, Palladini G, Walling J, Guthrie S, Nie C, Karp C, Jin Y, Kinney GG, Merlini G. Birtamimab plus standard of care in light-chain amyloidosis: the phase 3 randomized placebo-controlled VITAL trial. Blood. 2023 Oct 5;142(14):1208-1218. doi: 10.1182/blood.2022019406.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Birtamimab | Monoclonal antibody | 24 mg/kg | Intravenous |
| Background | Bortezomib | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Dexamethasone | Small molecule | — | — |