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New hope for myeloma: experimental drug linvoseltamab faces off against standard care in major trial

NCT ID NCT06932562

Disease control Sponsor: European Myeloma Network B.V. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 study is testing whether adding the experimental drug linvoseltamab after initial treatment can improve outcomes for people newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. About 1,000 participants will receive either standard therapy (daratumumab, lenalidomide, and dexamethasone) or the same drugs followed by linvoseltamab. The goal is to see if the new approach leads to deeper remission and longer survival.

What this could mean

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

Active substance
Linvoseltamab (also called REGN5458), a drug given after initial treatment with daratumumab, lenalidomide, and dexamethasone
What this could lead to
If it works, this could offer a more effective treatment option for people with newly diagnosed multiple myeloma who cannot have a stem cell transplant, potentially leading to longer remission and survival.
What could go wrong
This is an early-phase 3 trial, so results are not yet known. Linvoseltamab may not be more effective than standard care and could have side effects. The study is large but still experimental.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

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

Started

Dec 2025

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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.

Inclusion Criteria: 1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria. 2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol. 3. Participants must have measurable disease as defined in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. Participants must have clinical laboratory values within a prespecified range. Exclusion Criteria: 1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone. 2. Participants who defer transplant due to personal preference. 3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome. 4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of: * focal radiation and/or * a short course of corticosteroids as defined in the protocol. 5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM 6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1. 7. Participants who have uncontrolled intercurrent illness. 8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information. 9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time. 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

    59 sites in 18 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

  • A.O.U. Careggi

    RECRUITING

    Florence, Italy

  • AOU Ospedali Riuniti di Ancona

    RECRUITING

    Ancona, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, Denmark

  • Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

    RECRUITING

    Athens, Greece

  • Ankara University Faculty of Medicine, Department of Hematology

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Austin Hospital

    RECRUITING

    Heidelberg, Australia

  • Azienda Ospedaliera Santa Croce e Carle - Ematologia

    RECRUITING

    Cuneo, Italy

  • Azienda USL IRCCS Di Reggio Emilia

    RECRUITING

    Reggio, Italy

  • Barwon Health, University Hospital Geelong

    RECRUITING

    Geelong, Australia

  • Beaumont Hospital

    RECRUITING

    Dublin, Ireland

  • Box Hill Hospital

    RECRUITING

    Box Hill, Australia

  • CHUC

    RECRUITING

    Coimbra, Portugal

  • Canberra Hospital

    RECRUITING

    Canberra, Australia

  • Cork University Hospital

    RECRUITING

    Cork, Ireland

  • Ege Universitesi Tip Fakultesi - Hematology

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Ege University Medicine Faculty, Izmir

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Erasmus MC

    RECRUITING

    Rotterdam, Netherlands

  • Evaggelismos Hospital

    RECRUITING

    Athens, Greece

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, Czechia

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava, Czechia

  • Fakultni Nemocnice Plzen

    RECRUITING

    Pilsen, Czechia

  • Flinders Medical Centre

    RECRUITING

    Adelaide, Australia

  • Helsinki University Hospital Comprehensive Cancer Center

    RECRUITING

    Helsinki, Finland

  • Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit

    RECRUITING

    Barcelona, Spain

  • Hospital Quirón Salud Madrid

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service

    RECRUITING

    Santander, Spain

  • Hospital Universitario la Fe, Valencia

    RECRUITING

    Valencia, Spain

  • Hospital da Luz Lisboa

    RECRUITING

    Lisbon, Portugal

  • I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza

    RECRUITING

    San Giovanni Rotondo, Italy

  • IRCCS Ospedale Policlinico San Martino

    RECRUITING

    Genova, Italy

  • Institut Catala D'oncologia (Badalona)

    RECRUITING

    Badalona, Spain

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • Klinik Ottakring

    RECRUITING

    Vienna, Austria

  • Kuopio University Hospital

    RECRUITING

    Kuopio, Finland

  • Liv Hospital Ankara

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    RECRUITING

    Meldola, Italy

  • Nepean Cancer Centre

    RECRUITING

    Kingswood, Australia

  • North Estonia Medical Centre Foundation

    RECRUITING

    Tallinn, Estonia

  • Northern Hospital

    RECRUITING

    Melbourne, Australia

  • Ordensklinikum Linz

    RECRUITING

    Linz, Austria

  • Ospedale "Infermi" di Rimini

    RECRUITING

    Rimini, Italy

  • Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia

    RECRUITING

    Milan, Italy

  • Ospedale di Legnano, ASST Ovest Milanese

    RECRUITING

    Legnano, Italy

  • Skåne University Hospital, Region Skåne

    RECRUITING

    Lund, Sweden

  • St. Olavs hospital HF

    RECRUITING

    Trondheim, Norway

  • Stavanger University Hospital

    RECRUITING

    Stavanger, Norway

  • Sunshine Coast Health

    RECRUITING

    Sunshine Coast, Australia

  • Tartu University Hospital

    RECRUITING

    Tartu, Estonia

  • Theagenion Cancer Hospital

    RECRUITING

    Thessaloniki, Greece

  • Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie

    RECRUITING

    Lübeck, Germany

  • Universitaetsmedizin Greifswald

    RECRUITING

    Greifswald, Germany

  • Universitaetsspital Basel - Zentrum fur Hamato-Onkologie

    RECRUITING

    Basel, Switzerland

  • University Hospital Centre Zagreb - Clinic for Internal Medicine

    RECRUITING

    Zagreb, Croatia

  • University Hospital Limerick - Department of Haematology

    RECRUITING

    Limerick, Ireland

  • University Hospital Olomouc

    RECRUITING

    Olomouc, Czechia

  • University Hospital of Alexandroupolis

    RECRUITING

    Alexandroupoli, Greece

  • University Hospital of Würzburg

    RECRUITING

    Würzburg, Germany

  • Vestfold Hospital Trust

    RECRUITING

    Tønsberg, Norway

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