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
Lead Sponsor:
European Myeloma Network B.V.
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 trans...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06932562
Start Date
December 1 2025
End Date
December 1 2036
Last Update
December 12 2025
Active Locations (33)
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1
Austin Hospital
Heidelberg, Australia
2
Nepean Cancer Centre
Kingswood, Australia
3
Sunshine Coast Health
Sunshine Coast, Australia
4
Ordensklinikum Linz
Linz, Austria