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New drug linvoseltamab takes on multiple myeloma in early trial

NCT ID NCT05828511

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called linvoseltamab in people newly diagnosed with multiple myeloma, a type of blood cancer. The drug is designed to help the immune system attack cancer cells. The trial will check for side effects and see if the drug can shrink tumors. About 149 participants will take part, some before and after a stem cell transplant.

What this could mean

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

Active substance
linvoseltamab (a bispecific antibody that targets BCMA on myeloma cells and CD3 on immune cells)
What this could lead to
If successful, this could provide a new treatment option for newly diagnosed multiple myeloma, potentially improving response rates and depth of remission.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. Side effects, including immune reactions, are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 149 people

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

Started

Dec 2023

Expected to finish

Nov 2035

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. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 2. Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol 3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol 4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol 5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol 6. Participants must be age \<70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance. Key Exclusion Criteria: 1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis 2. Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment 3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy 4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes) Note: Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

How to take part

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

  1. The places running it

    32 sites in 3 countries. 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

  • CHU De Lille

    NOT_YET_RECRUITING

    Lille, 59000, France

  • Centre Hospitalier Universitaire (CHU) Montpellier

    RECRUITING

    Montpellier, 342950, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    RECRUITING

    Poitiers, Vienne, 86021, France

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Colorado Blood Cancer Institute/SCRI

    RECRUITING

    Denver, Colorado, 80218, United States

  • Columbia University _ New York Presbyterian

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Health System (DUHS)

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, Île-de-France Region, 94800, France

  • Hopital Necker

    RECRUITING

    Paris, Île-de-France Region, 75015, France

  • Hopital Prive d'Antony

    RECRUITING

    Antony, Île-de-France Region, 92160, France

  • Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Doctor Balmis Alicante

    RECRUITING

    Alicante, Valencia, 03010, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Quiron Salud Madrid

    RECRUITING

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Institut Catala dOncologia (ICO Hospitalet)

    RECRUITING

    Barcelona, 08908, Spain

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Irvine Health

    RECRUITING

    Orange, California, 92868, United States

  • Universitary Hospital La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • University Hospitals Pitie Salpetriere - Charles Foix

    RECRUITING

    Paris, 75651, France

  • University of California Los Angeles (UCLA)

    RECRUITING

    Los Angeles, California, 90095, United States

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