A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
← catalyst calendarNCT06140524 · readout in 2,098 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
116estimated
Sites
39
Countries
Belgium, France, Ireland +4
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 | 2024-09-16 | actual | When the study began enrolling |
| Primary completion | 2032-05-18 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-05-18 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Smoldering Multiple Myeloma (SMM)
Intervention
- Drug: Linvoseltamab — also filed as REGN5458, Lynozyfic™
Primary outcomes
what the primary-completion date above is the date OFFrequency of Adverse Events Interest (AEI) during the safety observation period
measured 35 days
Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period
measured 35 days
Severity of TEAEs during the safety observation period
measured 35 days
Achievement of Complete Response (CR) as determined by the investigator
measured Up to 5.5 years
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