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
NCT ID: NCT06932562
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2025-12-23
2036-12-31
Brief Summary
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The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm DRd
Daratumumab
Administered per the protocol
Lenalidomide
Administered per the protocol
Dexamethasone
Administered per the protocol
Experimental Arm DRd+ linvolsetamab
Linvoseltamab
Administered per the protocol
Daratumumab
Administered per the protocol
Lenalidomide
Administered per the protocol
Dexamethasone
Administered per the protocol
Interventions
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Linvoseltamab
Administered per the protocol
Daratumumab
Administered per the protocol
Lenalidomide
Administered per the protocol
Dexamethasone
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
European Myeloma Network B.V.
NETWORK
Responsible Party
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Principal Investigators
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Roberto Mina
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Città della Salute e della Scienza di Torino
Claudia Stege
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Austin Hospital
Heidelberg, , Australia
Nepean Cancer Centre
Kingswood, , Australia
Sunshine Coast Health
Sunshine Coast, , Australia
Ordensklinikum Linz
Linz, , Austria
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
Kuopio University Hospital
Kuopio, , Finland
University Hospital of Würzburg
Würzburg, , Germany
AOU Ospedali Riuniti di Ancona
Ancona, , Italy
A.O.U. Careggi
Florence, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, , 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
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
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Ege University Medicine Faculty, Izmir
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Hocking
Role: primary
Ponraj
Role: primary
Wallington-Gates
Role: primary
Strassl
Role: primary
Radocha
Role: primary
Minarik
Role: primary
Hajek
Role: primary
Jungova
Role: primary
Ølholm Vase
Role: primary
Loigom
Role: primary
Pärnat
Role: primary
Partanen
Role: primary
Waldschmidt
Role: primary
Offidani
Role: primary
Antonioli
Role: primary
Aquino
Role: primary
Cerchione
Role: primary
Gamberi
Role: primary
Rotondo
Role: primary
Carella
Role: primary
Stege
Role: primary
Haukås
Role: primary
Slørdahl
Role: primary
Moksnes
Role: primary
Roque
Role: primary
Pedrosa
Role: primary
Laura Rosiñol Dachs, MD
Role: primary
Martinez Chamorro
Role: primary
Enrique Ocio San Miguel, MD
Role: primary
de la Rubia
Role: primary
Heim
Role: primary
Lehmann
Role: primary
Comert
Role: primary
Other Identifiers
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2024-519827-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
EMN39
Identifier Type: -
Identifier Source: org_study_id
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