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Can a drug nip myeloma in the bud? new trial aims to stop cancer before it starts

NCT ID NCT06140524

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This Phase 2 trial is testing an investigational drug called linvoseltamab in 116 people with precancerous blood conditions that raise their risk of developing multiple myeloma. The goal is to see if the drug can eliminate abnormal plasma cells and lab signs of disease. Researchers will also monitor side effects and how the drug behaves in the body.

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 drug given by injection)
What this could lead to
If it works, this could point toward a way to stop precancerous conditions from turning into multiple myeloma, potentially preventing the disease.
What could go wrong
This is an early Phase 2 study with only 116 participants, so results may not apply to everyone. The drug may cause side effects, and it is not yet proven to prevent cancer.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 116 people

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

Started

Sep 2024

Expected to finish

May 2032

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. HR-MGUS or NHR-SMM as defined in the protocol 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 3. Adequate hematologic and hepatic function, as described in the protocol 4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation Key Exclusion Criteria: 1. High-risk SMM, as defined in the protocol 2. Evidence of any of myeloma-defining events, as described in the protocol 3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM 4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol 5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab 6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

monoclonal gammopathy of uncertain significance Smoldering Multiple Myeloma smoldering plasma cell myeloma

As listed by the trial registrant

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

Monoclonal gammopathy of undetermined significance (MGUS) Smoldering multiple myeloma (SMM)

How to take part

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

  1. The places running it

    39 sites in 7 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

  • AZ Sint Maarten Algemeen Ziekenhuis Emmaus

    RECRUITING

    Mechelen, Flanders, 2800, Belgium

  • AZ St.-Elisabeth Herentals vzw

    RECRUITING

    Herentals, Antwerp, 2200, Belgium

  • Algemeen Ziekenhuis (AZ) Klina

    RECRUITING

    Brasschaat, Antwerpen, 2930, Belgium

  • Algemeen Ziekenhuis AZ Delta

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Algemeen Ziekenhuis St Jan Brugge Oostende Av

    RECRUITING

    Bruges, West-Vlaanderen, 8000, Belgium

  • Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, Piedmont, 15121, Italy

  • Centre Hospitalier Universitaire De Poitiers

    RECRUITING

    Poitiers, New Aquitaine, 86000, France

  • Cork University Hospital

    RECRUITING

    Cork, T12 EC8P, Ireland

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Galway University Hospital

    RECRUITING

    Galway, Connacht, H91 YR71, Ireland

  • Hospital Clinico Universitario Virgen De La Arrixaca

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital Universitari Mutua Terrassa

    RECRUITING

    Terrassa, Barcelona, 08221, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Hospital de Cabuenes

    RECRUITING

    Gijón, Principality of Asturias, 33203, Spain

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genoa, Genova, 16132, Italy

  • Institut Catala dOncologia (ICO Hospitalet)

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Curie

    RECRUITING

    Paris, Île-de-France Region, 75005, France

  • Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori

    RECRUITING

    Meldola, Forli-Cesena, 47014, Italy

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, D07 R2WY, Ireland

  • NYU Langone Health Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • Pratia MCM Krakow

    RECRUITING

    Krakow, Malopolska, 30-510, Poland

  • San Paolo Hospital

    RECRUITING

    Milan, Lombardy, 20142, Italy

  • Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu

    RECRUITING

    Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Swietokrzyskie Centrum Onkologii

    RECRUITING

    Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno

    RECRUITING

    Ascoli Piceno, 63100, Italy

  • Universita degli Studi di Pavia - Fondazione IRCCS Policlini

    RECRUITING

    Pavia, 27100, Italy

  • Universitaru Hospital La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • University Clinical Center / Medical University of Gdansk

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-219, Poland

  • University of Michigan Health

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98109, United States

  • Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital

    RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)

    RECRUITING

    Lodz, 93-513, Poland

  • Ziekenhuis Netwerk Antwerpen Cadix, Hematology

    RECRUITING

    Antwerp, 2030, Belgium

More trials for these conditions

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