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Study identifier: NCT06932562 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

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

Condition: Multiple Myeloma  ·  Sponsor: European Myeloma Network B.V.

PhasePhase 3
Planned participants1000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where59 locations · 18 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Silvia Villa  ·  +31 10 268 70 65  ·  silvia.villa@emn.org

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (59)

Flinders Medical CentreAdelaide, AustraliaRecruiting
Box Hill HospitalBox Hill, AustraliaRecruiting
Canberra HospitalCanberra, AustraliaRecruiting
Barwon Health, University Hospital GeelongGeelong, AustraliaRecruiting
Austin HospitalHeidelberg, AustraliaRecruiting
Nepean Cancer CentreKingswood, AustraliaRecruiting
Northern HospitalMelbourne, AustraliaRecruiting
Sunshine Coast HealthSunshine Coast, AustraliaRecruiting
Ordensklinikum LinzLinz, AustriaRecruiting
Klinik OttakringVienna, AustriaRecruiting
University Hospital Centre Zagreb - Clinic for Internal MedicineZagreb, CroatiaRecruiting
Fakultni Nemocnice Hradec KraloveHradec Králové, CzechiaRecruiting

+ 47 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

AdelaideBox HillCanberraGeelong

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