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Last-Resort drug linvoseltamab offered to myeloma patients with no other options

NCT ID NCT05164250

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program provides linvoseltamab (REGN5458) to patients with relapsed or refractory multiple myeloma who have exhausted all standard treatments. The drug is a type of immunotherapy that helps the immune system attack cancer cells. It is given through compassionate use, meaning it is available outside of a clinical trial for those with no alternatives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linvoseltamab (REGN5458)
What this could lead to
If this treatment works, it could offer a new option for patients with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is a compassionate use program, not a formal trial, so data on safety and effectiveness is limited. The drug may not work for everyone and can cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

More trials for these conditions

Other studies related to the condition(s) this trial covers.