A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
← catalyst calendarNCT05828511 · readout in 3,361 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
149estimated
Sites
32
Countries
France, Spain, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-19 | actual | When the study began enrolling |
| Primary completion | 2035-11-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2035-11-02 | estimated | The whole study's end, after follow-up |
| First posted | 2023-04-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Multiple Myeloma
Intervention
- Drug: Linvoseltamab — also filed as REGN5458, Lynozyfic™
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose-Limiting Toxicities (DLTs)
measured End of the Observation period; up to day 28
Incidence of Treatment-Emergent Adverse Events (TEAEs)
measured Post-Last Linvoseltamab Dose, up to 90 days
Severity of TEAEs
measured Post-Last Linvoseltamab Dose, up to 90 days
Incidence of Adverse Events of Special Interest (AESIs)
measured Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
measured Post-Last Linvoseltamab Dose, up to 90 days
Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
measured Up to 5 years
Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
measured Up to 5 years
Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
measured Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
measured Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
measured Up to 5 years
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