Compares linvoseltamab with daratumumab in high-risk smoldering multiple myeloma
Tests linvoseltamab against daratumumab in adults with high-risk smoldering multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
Key facts
- Where
- Hwasun, Seoul, and Suwon, South KoreaSee the 7 sites
- Phase
- Phase 3
Where in South Korea
- Chonnam National University Hwasun HospitalHwasun, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Seoul St. Mary's Hospital, The Catholic University of KoreaSeoul, South KoreaTaking people
- Severance Hospital, Yonsei University Health SystemSeoul, South KoreaTaking people
- The Catholic University of Korea St Vincents HospitalSuwon, South KoreaTaking 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
- Regeneron Pharmaceuticals
- Trial code
- NCT07393282EU 2025-523252-31-00
- Record updated
- 4 November 2026
- Original description
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.Read full original descriptionShow less
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.
The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Inclusion: Eastern Cooperative Oncology Group performance status score ≤1; SMM diagnosis per IMWG criteria as defined in the protocol; Meets HR-SMM criteria by 1 of the risk models as defined in the protocol.
Exclusion: Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol; NOTE: Other protocol defined inclusion/exclusion criteria apply; History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder; History of a seizure within the 12 months of randomization; Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol; Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma.