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.
- Diseases
- Multiple myeloma
- 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
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Stadt Wien Wiener Gesundheitsverbund Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Canberra Hospital Coordinator of this site? Confirm its status | Canberra | Australia | Recruiting |
| Barwon Health - University Hospital Geelong Coordinator of this site? Confirm its status | Geelong | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Nepean Cancer Centre Coordinator of this site? Confirm its status | Kingswood | Australia | Recruiting |
| Northern Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Sunshine Coast Health Coordinator of this site? Confirm its status | Sunshine Coast | Australia | Recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Chu Helora Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Universitaetsspital Basel - Zentrum fur Hamato-Onkologie Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| North Estonia Medical Centre Foundation Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
| Tartu University Hospital Coordinator of this site? Confirm its status | Tartu Linn | Estonia | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Recruiting |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Recruiting |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Recruiting |
| University Hospital Limerick Coordinator of this site? Confirm its status | Limerick | Ireland | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera Santa Croce E Carle Coordinator of this site? Confirm its status | Cuneo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Ovest Milanese Coordinator of this site? Confirm its status | Legnano | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Helse Stavanger HF Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| Sykehuset I Vestfold HF Coordinator of this site? Confirm its status | Toensberg | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Ankara University Faculty of Medicine, Department of Hematology Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Liv Hospital Ankara Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ege Universitesi Tip Fakultesi - Hematology Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Ege University Medicine Faculty, Izmir Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.