NCT06932562Recruiting
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
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.
Inclusion criteria
1. Participants must have confirmed diagnosis of symptomatic MM per IMWG 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
1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone. 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. NOTE Other protocol defined inclusion/exclusion criteria apply.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, Germany, Italy, Austria, Australia, Croatia, Czechia, Denmark, Estonia, Finland, Greece, Ireland, Netherlands, Norway, Portugal, Spain, Sweden, Turkey (Türkiye)
- Sponsor
- European Myeloma Network B.V.(Network / cooperative)
- Protocol no.
- EMN39
- Conditions
- Multiple Myeloma
- Interventions
- Drug
Treatments studied
- Linvoseltamab
- Daratumumab
- Lenalidomide
- Dexamethasone
Collaborators
Regeneron Pharmaceuticals
Locations · 59
- Basel, SwitzerlandUniversitaetsspital Basel - Zentrum fur Hamato-OnkologieRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Greifswald, GermanyUniversitaetsmedizin GreifswaldRecruiting at this site
- Lübeck, GermanyUniversitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und OnkologieRecruiting at this site
- Würzburg, GermanyUniversity Hospital of WürzburgRecruiting at this site
- Ancona, ItalyAOU Ospedali Riuniti di AnconaRecruiting at this site
- Cuneo, ItalyAzienda Ospedaliera Santa Croce e Carle - EmatologiaRecruiting at this site
- Florence, ItalyA.O.U. CareggiRecruiting at this site
- Genova, ItalyIRCCS Ospedale Policlinico San MartinoRecruiting at this site
- Legnano, ItalyOspedale di Legnano, ASST Ovest MilaneseRecruiting at this site
- Meldola, ItalyMeldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)Recruiting at this site
- Milan, ItalyASST Grande Ospedale Metropolitano NiguardaRecruiting at this site
- Milan, ItalyOspedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - OncologiaRecruiting at this site
- Reggio, ItalyAzienda USL IRCCS Di Reggio EmiliaRecruiting at this site
- Rimini, ItalyOspedale "Infermi" di RiminiRecruiting at this site
- San Giovanni Rotondo, ItalyI.R.C.C.S. Ospedale Casa Sollievo della SofferenzaRecruiting at this site
- Linz, AustriaOrdensklinikum LinzRecruiting at this site
- Vienna, AustriaKlinik OttakringRecruiting at this site
- Adelaide, AustraliaFlinders Medical CentreRecruiting at this site
- Box Hill, AustraliaBox Hill HospitalRecruiting at this site
- Canberra, AustraliaCanberra HospitalRecruiting at this site
- Geelong, AustraliaBarwon Health, University Hospital GeelongRecruiting at this site
- Heidelberg, AustraliaAustin HospitalRecruiting at this site
- Kingswood, AustraliaNepean Cancer CentreRecruiting at this site
- Melbourne, AustraliaNorthern HospitalRecruiting at this site
- Sunshine Coast, AustraliaSunshine Coast HealthRecruiting at this site
- Zagreb, CroatiaUniversity Hospital Centre Zagreb - Clinic for Internal MedicineRecruiting at this site
- Hradec Králové, CzechiaFakultni Nemocnice Hradec KraloveRecruiting at this site
- Olomouc, CzechiaUniversity Hospital OlomoucRecruiting at this site
- Ostrava, CzechiaFakultni Nemocnice OstravaRecruiting at this site
In total, worldwide, all 59 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: March 25, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 29 more locations
Other identifiers
- 2024-519827-16-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.