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DaraVCD in Multiple Myeloma with Extramedullary Disease (ANTARES)
NCT04166565Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2019
- Primary completion
- Mar 2027
- Countries
- 3
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- daratumumab
- Conditions
- multiple myeloma (MM)extramedullary plasmacytoma (EMP)
01
Overview
Phase 2, open-label, single-arm trial of daratumumab in multiple myeloma (MM) and extramedullary plasmacytoma (EMP). Primary endpoint: Complete Response or better at 5 years. Started Oct 2019; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
DaraVCD
Daratumumab + Bortezomib + Cyclophosphamide + Dexamethasone
03
Who it enrols
Adult patients with newly diagnosed or relapsed (max 1 prior line) multiple myeloma presenting with extramedullary disease, with measurable disease and adequate organ function.
04
Endpoints
Primary
Complete Response or better
Secondary
Duration of Response
Progression-Free Survival
Overall Response Rate
Overall Survival
Adverse Events
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