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Approved for marketingNCT05164250Updated Nov 10, 2025

Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)

An expanded access record providing REGN5458 in Multiple Myeloma, sponsored by Regeneron Pharmaceuticals. Approved for marketing. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by Regeneron Pharmaceuticals · Expanded access

Study type
Expanded access
Access type
Individual patients
01

Study summary

Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma

Read the detailed description

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Relapsed, Refractory
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

Browse Multiple Myeloma studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)

Inclusion criteria

-

Exclusion criteria

Exclusion Criteria:

-

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugREGN5458

    Also known as: BCMAxCD3, linvoseltamab

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT05164250
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 20, 2021
Last update
Nov 10, 2025
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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