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Isa-VRdlite in High Risk Newly Diagnosed Multiple Myeloma
NCT07732712Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Jan 2027
- Primary completion
- Dec 2028
- Sponsor
- The Affiliated People’s Hospital of Ningbo University
- Drugs
- isatuximab
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 3, open-label, single-arm trial of isatuximab in multiple myeloma (MM), sponsored by The Affiliated People’s Hospital of Ningbo University. Primary endpoints: Overall Response Rate at 12 months and 12-cycle clearance rate of circulating plasma cells at 12 months. Planned start Jan 2027; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Isa-VRdlite for high risk fail MM patinets base on CPSc
Isatuximab plus reduced-intensity VRD (VRDlite) induction therapy
03
Who it enrols
Adults with newly diagnosed, transplant-ineligible symptomatic multiple myeloma with CPCs >= 0.07%, ECOG 0-3, and no prior anti-myeloma therapy.
04
Endpoints
Primary
Overall Response Rate
12-cycle clearance rate of circulating plasma cells
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