Clinical trial
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With…
NCT03201965 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT03201965 |
|---|---|
| Title | A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis |
| Official title | A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Amyloidosis |
| Intervention type | Drug |
| Interventions | Cyclophosphamide, Bortezomib, Dexamethasone, 40 mg, Daratumumab |
| Enrollment | 416 |
| Start date | Oct 5, 2017 |
| Primary completion | Feb 14, 2020 |
| Completion | Nov 19, 2024 |
| First posted | Jun 28, 2017 |
| Last update posted | Nov 26, 2025 |
| Countries | Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hungary, Israel, Italy and 10 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: