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

Recruiting now · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06932562

Run by

European Myeloma Network B.V.

People needed

1000

Starts

2025-12-23

Expected to finish

2036-12-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
• 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.
• Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
• NOTE Other protocol defined inclusion/exclusion criteria apply.

Where it is running

• Box Hill Hospital — Box Hill, Australia (enrolling)
• Canberra Hospital — Canberra, Australia (enrolling)
• Barwon Health, University Hospital Geelong — Geelong, Australia (enrolling)
• Austin Hospital — Heidelberg, Australia (enrolling)
• Nepean Cancer Centre — Kingswood, Australia (enrolling)
• Northern Hospital — Melbourne, Australia (enrolling)
• Sunshine Coast Health — Sunshine Coast, Australia (enrolling)
• Ordensklinikum Linz — Linz, Austria (enrolling)
• Klinik Ottakring — Vienna, Austria (enrolling)
• University Hospital Centre Zagreb - Clinic for Internal Medicine — Zagreb, Croatia (enrolling)
• Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia (enrolling)
• University Hospital Olomouc — Olomouc, Czechia (enrolling)
• Fakultni Nemocnice Ostrava — Ostrava, Czechia (enrolling)
• Fakultni Nemocnice Plzen — Pilsen, Czechia (enrolling)
• Aarhus Universitetshospital — Aarhus, Denmark (enrolling)
• North Estonia Medical Centre Foundation — Tallinn, Estonia (enrolling)
• Tartu University Hospital — Tartu, Estonia (enrolling)
• Helsinki University Hospital Comprehensive Cancer Center — Helsinki, Finland (enrolling)
• Kuopio University Hospital — Kuopio, Finland (enrolling)
• Universitaetsmedizin Greifswald — Greifswald, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie — Lübeck, Germany (enrolling)
• University Hospital of Würzburg — Würzburg, Germany (enrolling)
• University Hospital of Alexandroupolis — Alexandroupoli, Greece (enrolling)
• Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens — Athens, Greece (enrolling)
• Flinders Medical Centre — Adelaide, Australia (enrolling)

Full record on ClinicalTrials.gov

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