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Clinical Trials in Ireland / NCT06932562
Recruiting Phase 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

NCT06932562 · tracked via the Priya Life Science Ireland tracker
Sponsor
European Myeloma Network B.V.
Phase
Phase 3
Started
2025-12-23
Last updated
2026-03-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

LinvoseltamabDaratumumabLenalidomideDexamethasone

Linvoseltamab: Administered per the protocol

Daratumumab: Administered per the protocol

Lenalidomide: Administered per the protocol

Dexamethasone: Administered per the protocol

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Flinders Medical Centre Adelaide Australia Recruiting
Box Hill Hospital Box Hill Australia Recruiting
Canberra Hospital Canberra Australia Recruiting
Barwon Health, University Hospital Geelong Geelong Australia Recruiting
Austin Hospital Heidelberg Australia Recruiting
Nepean Cancer Centre Kingswood Australia Recruiting
Northern Hospital Melbourne Australia Recruiting
Sunshine Coast Health Sunshine Coast Australia Recruiting
Ordensklinikum Linz Linz Austria Recruiting
Klinik Ottakring Vienna Austria Recruiting
University Hospital Centre Zagreb - Clinic for Internal Medicine Zagreb Croatia Recruiting
Fakultni Nemocnice Hradec Kralove Hradec Králové Czechia Recruiting
University Hospital Olomouc Olomouc Czechia Recruiting
Fakultni Nemocnice Ostrava Ostrava Czechia Recruiting
Fakultni Nemocnice Plzen Pilsen Czechia Recruiting
Aarhus Universitetshospital Aarhus Denmark Recruiting
North Estonia Medical Centre Foundation Tallinn Estonia Recruiting
Tartu University Hospital Tartu Estonia Recruiting
Helsinki University Hospital Comprehensive Cancer Center Helsinki Finland Recruiting
Kuopio University Hospital Kuopio Finland Recruiting
Universitaetsmedizin Greifswald Greifswald Germany Recruiting
Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie Lübeck Germany Recruiting
University Hospital of Würzburg Würzburg Germany Recruiting
University Hospital of Alexandroupolis Alexandroupoli Greece Recruiting
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens Athens Greece Recruiting
Evaggelismos Hospital Athens Greece Recruiting
Theagenion Cancer Hospital Thessaloniki Greece Recruiting
Cork University Hospital Cork Ireland Recruiting
Beaumont Hospital Dublin Ireland Recruiting
University Hospital Limerick - Department of Haematology Limerick Ireland Recruiting
AOU Ospedali Riuniti di Ancona Ancona Italy Recruiting
Azienda Ospedaliera Santa Croce e Carle - Ematologia Cuneo Italy Recruiting
A.O.U. Careggi Florence Italy Recruiting
IRCCS Ospedale Policlinico San Martino Genova Italy Recruiting
Ospedale di Legnano, ASST Ovest Milanese Legnano Italy Recruiting
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) Meldola Italy Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia Milan Italy Recruiting
Azienda USL IRCCS Di Reggio Emilia Reggio Italy Recruiting
Ospedale "Infermi" di Rimini Rimini Italy Recruiting

+ 19 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06932562 on ClinicalTrials.gov ↗ ← All trials in Ireland