A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
← catalyst calendarNCT07393282 · readout in 2,534 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
270estimated
Sites
3
Country
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 | 2026-05-21 | actual | When the study began enrolling |
| Primary completion | 2033-07-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-07-27 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- High Risk Smoldering Multiple Myeloma (HR-SMM)
Interventions
- Drug: Linvoseltamab — also filed as REGN5458, Lynozyfic™
- Drug: Daratumumab — also filed as Darzalex Faspro®, Darzalex®
Primary outcomes
what the primary-completion date above is the date OFClinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
measured Up to 5 years
Biochemical PFS per IMWG criteria
measured Up to 5 years
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