A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
← catalyst calendarNCT05955508 · readout in 2,350 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
40actual
Sites
17
Country
Spain
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 | 2024-01-30 | actual | When the study began enrolling |
| Primary completion | 2033-01-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-01-25 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- 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 of Special Interest (AESI) during the safety run-in observation period
measured Up to 35 days
Frequency of Treatment-Emergent Adverse Events (TEAEs) during the safety run-in observation period
measured Up to 35 days
Severity of TEAEs during the safety run-in observation period
measured Up to 35 days
Complete Response (CR) as determined by the investigator
measured Up to 7 years
Minimal Residual Disease (MRD) negativity
measured At 12 months
MRD negativity
measured At 24 months
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