Tests linvoseltamab against standard treatment in multiple myeloma
Tests linvoseltamab against standard treatment in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Alexandria, Ancona, Bari, Bologna, Brescia, Catania, Cuneo, Florence, Genoa, Legnano, Meldola, Milan, Padova, Palermo, Pavia, Reggio Emilia, Rimini, Rome, San Giovanni Rotondo, Turin, and Udine, ItalySee the 23 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?
Source: NCT06932562, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, ItalyTaking people
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Universitaria Ospedaliera Consorziale Policlinico BariBari, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Azienda Ospedaliera Santa Croce E CarleCuneo, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Ovest MilaneseLegnano, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermo, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- European Myeloma Network B.V.
- Trial code
- NCT06932562EU 2024-519827-16-00
- Record updated
- 25 March 2026
- Original description
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).Read full original descriptionShow less
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
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: 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.
Exclusion: 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; 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; International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone; Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.