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Can a Pre-Dose prevent a dangerous reaction in multiple myeloma treatment?

NCT ID NCT07609940

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tests whether giving tocilizumab before the first dose of linvoseltamab can lower the risk of cytokine release syndrome (CRS) in people with relapsed or refractory multiple myeloma. The 30 participants have already tried at least four prior treatments. Researchers will monitor CRS severity, hospital visits, and side effects to see if this approach is safe and effective.

What this could mean

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

Active substance
tocilizumab and linvoseltamab
What this could lead to
If it works, this could make a new multiple myeloma treatment safer by reducing a serious side effect called cytokine release syndrome.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to everyone. The approach may not reduce side effects as hoped.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Key Inclusion Criteria: 1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2 3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy Key Exclusion Criteria: 1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome 2. Known myeloma brain lesions or meningeal involvement 3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \[PML\], or Central Nervous System (CNS) movement disorder NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm cytokine release syndrome prevention target

As listed by the trial registrant

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

Relapsed refractory multiple myeloma (RRMM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Berenson Cancer Center

    RECRUITING

    Los Angeles, California, 90069, United States

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Northwest Medical Specialties, PLLC

    RECRUITING

    Tacoma, Washington, 98405, United States

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