Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

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NCT03761108 · readout in 2,415 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

387estimated

Sites

Countries

Belgium, Germany, Japan +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

2019-01-23

actual

When the study began enrolling

Primary completion

2033-03-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2033-06-16

estimated

The whole study's end, after follow-up

First posted

2018-12-03

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-20

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Multiple Myeloma

Intervention

Drug: Linvoseltamab — also filed as REGN5458, Lynozyfic™

Primary outcomes

what the primary-completion date above is the date OF

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

measured Up to 28 days

Incidence and severity of treatment-emergent adverse events (TEAEs)

measured Up to 5 years

Incidence and severity of adverse events of special interest (AESI)

measured Up to 5 years

Assessment of the pharmacokinetics (PK) of linvoseltamab

measured Up to 5 years

Concentrations of linvoseltamab in serum over time

measured Up to 5 years

Objective response rate (ORR) as determined by an Independent Review Committee (IRC)

measured Up to 5 years

Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab

measured Up to 5 years

ORR of IV linvoseltamab as assessed by investigator

measured Up to 5 years

Publications

PMID 42564571 — linked by the registry
PMID 41387038 — linked by the registry
PMID 38879802 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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