First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
← catalyst calendarSponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
43actual
Sites
7
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 | 2019-09-26 | actual | When the study began enrolling |
| Primary completion | 2025-05-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-01 | actual | The whole study's end, after follow-up |
| First posted | 2019-09-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed Multiple Myeloma
- Refractory Multiple Myeloma
Intervention
- Drug: REGN5459
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
measured Up to 35 Days
Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
measured Up to 12 Weeks After the Last Dose
Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
measured Up to 12 Weeks After the Last Dose
Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria
measured Up to Approximately 104 Weeks
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