RecruitingPhase 3NCT06932562

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

Sponsor

European Myeloma Network B.V.

Enrollment

1,000 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called linvoseltamab, which is a type of targeted immunotherapy, in people with a blood cancer called multiple myeloma. Researchers want to see how well it works and whether it is safe when combined with other treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma - You have already received previous treatments for myeloma that are no longer working - You meet the health requirements to receive immunotherapy - You are an adult in reasonably good overall health **You may NOT be eligible if...** - You have serious infections or uncontrolled illnesses - You have significant heart, liver, or kidney problems - You have had certain prior treatments that would interfere with this drug - You are pregnant or breastfeeding - You have active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

Administered per the protocol

DRUGDaratumumab

Administered per the protocol

DRUGLenalidomide

Administered per the protocol

DRUGDexamethasone

Administered per the protocol

Locations(59)

Flinders Medical Centre

Adelaide, Australia

Box Hill Hospital

Box Hill, Australia

Canberra Hospital

Canberra, Australia

Barwon Health, University Hospital Geelong

Geelong, Australia

Austin Hospital

Heidelberg, Australia

Nepean Cancer Centre

Kingswood, Australia

Northern Hospital

Melbourne, Australia

Sunshine Coast Health

Sunshine Coast, Australia

Ordensklinikum Linz

Linz, Austria

Klinik Ottakring

Vienna, Austria

University Hospital Centre Zagreb - Clinic for Internal Medicine

Zagreb, Croatia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

University Hospital Olomouc

Olomouc, Czechia

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Fakultni Nemocnice Plzen

Pilsen, Czechia

Aarhus Universitetshospital

Aarhus, Denmark

North Estonia Medical Centre Foundation

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Universitaetsmedizin Greifswald

Greifswald, Germany

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

Lübeck, Germany

University Hospital of Würzburg

Würzburg, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

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

Athens, Greece

Evaggelismos Hospital

Athens, Greece

Theagenion Cancer Hospital

Thessaloniki, Greece

Cork University Hospital

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

University Hospital Limerick - Department of Haematology

Limerick, Ireland

AOU Ospedali Riuniti di Ancona

Ancona, Italy

Azienda Ospedaliera Santa Croce e Carle - Ematologia

Cuneo, Italy

A.O.U. Careggi

Florence, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

Ospedale di Legnano, ASST Ovest Milanese

Legnano, Italy

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

Meldola, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia

Milan, Italy

Azienda USL IRCCS Di Reggio Emilia

Reggio, Italy

Ospedale "Infermi" di Rimini

Rimini, Italy

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

San Giovanni Rotondo, Italy

Erasmus MC

Rotterdam, Netherlands

Stavanger University Hospital

Stavanger, Norway

St. Olavs hospital HF

Trondheim, Norway

Vestfold Hospital Trust

Tønsberg, Norway

CHUC

Coimbra, Portugal

Hospital da Luz Lisboa

Lisbon, Portugal

Institut Catala D'oncologia (Badalona)

Badalona, Spain

Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit

Barcelona, Spain

Hospital Quirón Salud Madrid

Madrid, Spain

Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service

Santander, Spain

Hospital Universitario la Fe, Valencia

Valencia, Spain

Skåne University Hospital, Region Skåne

Lund, Sweden

Universitaetsspital Basel - Zentrum fur Hamato-Onkologie

Basel, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Ankara University Faculty of Medicine, Department of Hematology

Ankara, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi - Hematology

Izmir, Turkey (Türkiye)

Ege University Medicine Faculty, Izmir

Izmir, Turkey (Türkiye)

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NCT06932562

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