Compares linvoseltamab with daratumumab in high-risk smoldering multiple myeloma
Tests linvoseltamab against daratumumab in adults with high-risk smoldering multiple myeloma.
Key facts
- Who runs it
- Regeneron Pharmaceuticals
- Where
- Hamburg, Heidelberg, and Oldenburg, GermanySee the 3 sitesAlso in 10 other countries, 72 sites
- Trial code
- Registry title
- A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 270 people, planned
- Started
- 21 May 2026
- Expected to end
- 27 Jul 2033
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Linvoseltamab
- Daratumumab
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with smoldering multiple myeloma who are at high risk of developing active multiple myeloma. It compares linvoseltamab with daratumumab.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Smoldering multiple myeloma at high risk of becoming active multiple myeloma, as defined in the protocol
- Earlier treatment
- Cannot have had any earlier treatment for a plasma cell disorder, such as chemotherapy, radiotherapy, immunomodulatory drugs, proteasome inhibitors or anti-CD38 antibodies
Main reasons for not taking part
- Signs of myeloma-defining events
- Systemic light chain amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia or soft tissue plasmacytoma
- History of a neurodegenerative condition, progressive multifocal leukoencephalopathy or a central nervous system movement disorder
- A seizure within the 12 months before randomization
- Ongoing treatment with other monoclonal antibodies or other treatments likely to interfere with the study
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Germany
Also in 10 other countries, 72 sites
- University Medical Center Hamburg-EppendorfHamburg, GermanyNot yet recruiting
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyNot yet recruiting
- Klinikum Oldenburg AorOldenburg, GermanyNot yet recruiting
About the trial
What the trial wants to find out
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
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)
The 2 groups in the trial
- LinvoseltamabTreatment being tested
- DaratumumabExisting treatment, for comparison
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
- Plain-language title
- Compares linvoseltamab with daratumumab in high-risk smoldering multiple myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 4 November 2026