Fact CheckerSign in

NCT06932562RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
10 Apr 2025
Start date
23 Dec 2025
Primary completion date
Dec 2036
Lead sponsor
European Myeloma Network B.V.
NCT number
NCT06932562
EU CT number
2024-519827-16-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1000
  • From 23 Dec 2025 to the primary completion date, Dec 2036
  • 79 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who defer transplant due to personal preference.
  • 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.
  • 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.
  • Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
  • 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.

Other illness

  • Participants who have uncontrolled intercurrent illness.
  • History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
    • NOTE Other protocol defined inclusion/exclusion criteria apply.

Age

  • International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.

Other

  • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
Coordinator of this site? Confirm its status
LinzAustriaRecruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Coordinator of this site? Confirm its status
SalzburgAustriaRecruiting
Stadt Wien Wiener Gesundheitsverbund
Coordinator of this site? Confirm its status
ViennaAustriaRecruiting
Flinders Medical Centre
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Box Hill Hospital
Coordinator of this site? Confirm its status
Box HillAustraliaRecruiting
Canberra Hospital
Coordinator of this site? Confirm its status
CanberraAustraliaRecruiting
Barwon Health - University Hospital Geelong
Coordinator of this site? Confirm its status
GeelongAustraliaRecruiting
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaRecruiting
Nepean Cancer Centre
Coordinator of this site? Confirm its status
KingswoodAustraliaRecruiting
Northern Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaRecruiting
Sunshine Coast Health
Coordinator of this site? Confirm its status
Sunshine CoastAustraliaRecruiting
Ziekenhuis Aan De Stroom
Coordinator of this site? Confirm its status
AntwerpBelgiumRecruiting
Chu Helora
Coordinator of this site? Confirm its status
La LouvièreBelgiumRecruiting
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Coordinator of this site? Confirm its status
BaselSwitzerlandRecruiting
Kantonsspital St. Gallen
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandRecruiting
Fakultni nemocnice Brno
Coordinator of this site? Confirm its status
BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaRecruiting
University Hospital Olomouc
Coordinator of this site? Confirm its status
OlomoucCzechiaRecruiting
Fakultni nemocnice Ostrava
Coordinator of this site? Confirm its status
OstravaCzechiaRecruiting
Fakultni Nemocnice Plzen
Coordinator of this site? Confirm its status
Plzen 23CzechiaRecruiting
Universitaetsmedizin Greifswald KöR
Coordinator of this site? Confirm its status
GreifswaldGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
Coordinator of this site? Confirm its status
LuebeckGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyRecruiting
Region Midtjylland
Coordinator of this site? Confirm its status
Aarhus NDenmarkRecruiting
Region Sjaelland
Coordinator of this site? Confirm its status
RoskildeDenmarkRecruiting
North Estonia Medical Centre Foundation
Coordinator of this site? Confirm its status
TallinnEstoniaRecruiting
Tartu University Hospital
Coordinator of this site? Confirm its status
Tartu LinnEstoniaRecruiting
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status
SantanderSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
HUS-Yhtymae
Coordinator of this site? Confirm its status
HelsinkiFinlandRecruiting
Kuopio University Hospital
Coordinator of this site? Confirm its status
KuopioFinlandRecruiting
University General Hospital of Alexandroupoli
Coordinator of this site? Confirm its status
AlexandroupoliGreeceRecruiting
Evangelismos S A
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Alexandra Hospital
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
Theageneio Cancer Hospital
Coordinator of this site? Confirm its status
ThessalonikiGreeceRecruiting
University Hospital Centre Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaRecruiting
Cork University Hospital
Coordinator of this site? Confirm its status
CorkIrelandRecruiting
Beaumont Hospital
Coordinator of this site? Confirm its status
Dublin 9IrelandRecruiting
University Hospital Galway
Coordinator of this site? Confirm its status
GalwayIrelandRecruiting
University Hospital Limerick
Coordinator of this site? Confirm its status
LimerickIrelandRecruiting
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Coordinator of this site? Confirm its status
AlexandriaItalyRecruiting
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyRecruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Coordinator of this site? Confirm its status
BariItalyRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Azienda Ospedaliera Santa Croce E Carle
Coordinator of this site? Confirm its status
CuneoItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
IRCCS Azienda Ospedaliera Metropolitana
Coordinator of this site? Confirm its status
GenoaItalyRecruiting
Azienda Socio Sanitaria Territoriale Ovest Milanese
Coordinator of this site? Confirm its status
LegnanoItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
Coordinator of this site? Confirm its status
MeldolaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliera di Padova
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
Coordinator of this site? Confirm its status
PaviaItalyRecruiting
Azienda USL IRCCS di Reggio Emilia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyRecruiting
Azienda Unita Sanitaria Locale Della Romagna
Coordinator of this site? Confirm its status
RiminiItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Casa Sollievo della Sofferenza
Coordinator of this site? Confirm its status
San Giovanni RotondoItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Azienda Sanitaria Universitaria Friuli Centrale
Coordinator of this site? Confirm its status
UdineItalyRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Coordinator of this site? Confirm its status
RotterdamNetherlandsRecruiting
Oslo University Hospital HF
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
Helse Stavanger HF
Coordinator of this site? Confirm its status
StavangerNorwayRecruiting
Sykehuset I Vestfold HF
Coordinator of this site? Confirm its status
ToensbergNorwayRecruiting
St. Olavs hospital HF
Coordinator of this site? Confirm its status
TrondheimNorwayRecruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coordinator of this site? Confirm its status
CoimbraPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Coordinator of this site? Confirm its status
PortoPortugalRecruiting
Region Skane Skanes Universitetssjukhus
Coordinator of this site? Confirm its status
LundSwedenRecruiting
Ankara University Faculty of Medicine, Department of Hematology
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Liv Hospital Ankara
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ege Universitesi Tip Fakultesi - Hematology
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting
Ege University Medicine Faculty, Izmir
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.