Clinical trial ANDROMEDA
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
| Cancers | |
|---|---|
| Organ | Amyloidose |
| Trial status | Trial closed for recruitment |
| Investigator | |
| Trial type |
Interventional with experimental drug
|
| Phase | Trial phase 3 |
| Academic trial | Non |
| Sponsor | Janssen |
| EudraCT Identifier | 2016-001737-27 |
| ClinicalTrials.gov | https://clinicaltrials.gov/ct2/show/NCT03201965 |
| Inclusion criteria | - Histopathological diagnosis of amyloidosis- Measurable disease of amyloid light chain amyloidosis as defined by at least ONEof the following: serum M-protein ?0.5 g/dL by protein electrophoresis or serum free light chain ?50 mg/L- One or more organs |
| Last update |