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
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
• Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
• Participants must have measurable disease as defined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have clinical laboratory values within a prespecified range.
Locations
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Box Hill Hospital
RECRUITING
Box Hill
Canberra Hospital
RECRUITING
Canberra
Barwon Health, University Hospital Geelong
RECRUITING
Geelong
Austin Hospital
RECRUITING
Heidelberg
Nepean Cancer Centre
RECRUITING
Kingswood
Northern Hospital
RECRUITING
Melbourne
Sunshine Coast Health
RECRUITING
Sunshine Coast
Austria
Ordensklinikum Linz
RECRUITING
Linz
Klinik Ottakring
RECRUITING
Vienna
Croatia
University Hospital Centre Zagreb - Clinic for Internal Medicine
RECRUITING
Zagreb
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
Finland
Helsinki University Hospital Comprehensive Cancer Center
RECRUITING
Helsinki
Kuopio University Hospital
RECRUITING
Kuopio
Germany
Universitaetsmedizin Greifswald
RECRUITING
Greifswald
Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie
RECRUITING
Lübeck
University Hospital of Würzburg
RECRUITING
Würzburg
Greece
University Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
RECRUITING
Athens
Evaggelismos Hospital
RECRUITING
Athens
Theagenion Cancer Hospital
RECRUITING
Thessaloniki
Ireland
Cork University Hospital
RECRUITING
Cork
Beaumont Hospital
RECRUITING
Dublin
University Hospital Limerick - Department of Haematology
RECRUITING
Limerick
Italy
AOU Ospedali Riuniti di Ancona
RECRUITING
Ancona
Azienda Ospedaliera Santa Croce e Carle - Ematologia
RECRUITING
Cuneo
A.O.U. Careggi
RECRUITING
Florence
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Ospedale di Legnano, ASST Ovest Milanese
RECRUITING
Legnano
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia
RECRUITING
Milan
Azienda USL IRCCS Di Reggio Emilia
RECRUITING
Reggio
Ospedale Infermi di Rimini
RECRUITING
Rimini
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Norway
Stavanger University Hospital
RECRUITING
Stavanger
Vestfold Hospital Trust
RECRUITING
Tønsberg
St. Olavs hospital HF
RECRUITING
Trondheim
Portugal
CHUC
RECRUITING
Coimbra
Hospital da Luz Lisboa
RECRUITING
Lisbon
Spain
Institut Catala D'oncologia (Badalona)
RECRUITING
Badalona
Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit
RECRUITING
Barcelona
Hospital Quirón Salud Madrid
RECRUITING
Madrid
Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service
RECRUITING
Santander
Hospital Universitario la Fe, Valencia
RECRUITING
Valencia
Sweden
Skåne University Hospital, Region Skåne
RECRUITING
Lund
Switzerland
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
RECRUITING
Basel
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Turkey
Ankara University Faculty of Medicine, Department of Hematology
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Ege Universitesi Tip Fakultesi - Hematology
RECRUITING
Izmir
Ege University Medicine Faculty, Izmir
RECRUITING
Izmir
Contact Information
Primary
Silvia Villa
silvia.villa@emn.org
+31 10 268 70 65
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2036-12
Participants
Target number of participants: 1000
Treatments
Active_comparator: Control arm DRd
Experimental: Experimental Arm DRd+ linvolsetamab
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: European Myeloma Network B.V.