A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
← catalyst calendarNCT07222761 · readout in 1,006 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
915estimated
Sites
20
Countries
Australia, South Korea, United Kingdom +1
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 | 2026-01-02 | actual | When the study began enrolling |
| Primary completion | 2029-05-21 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2034-08-23 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed and/or Refractory Multiple Myeloma (RRMM)
Interventions
- Drug: Linvoseltamab — also filed as REGN5458, Lynozyfic™
- Drug: Carfilzomib — also filed as Kyprolis®
- Drug: Daratumumab — also filed as Darzalex Faspro®, Darzalex®
- Drug: Dexamethasone — also filed as Dexahexal®
- Drug: Pomalidomide — also filed as Imnovid®, Pomalyst®
- Drug: Bortezomib — also filed as Velcade®
Primary outcomes
what the primary-completion date above is the date OFOccurrence of Treatment Emergent Adverse Events (TEAEs)
measured Up to 5 years
Severity of TEAEs
measured Up to 5 years
Occurrence of Adverse Events of Special Interest (AESI)
measured Up to 5 years
Severity of AESIs
measured Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
measured Up to 5 years
Severity of SAEs
measured Up to 5 years
Minimal Residual Disease (MRD)-negative Complete Response (CR)
measured At 12 months
Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC
measured Up to 5 years
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