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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
Sponsor: European Myeloma Network B.V.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-12-23
Completion Date
2036-12
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Linvoseltamab
Administered per the protocol
Daratumumab
Administered per the protocol
Lenalidomide
Administered per the protocol
Dexamethasone
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)