Taking people in EstoniaPhase 3
Tests linvoseltamab against standard treatment in multiple myeloma
Tests linvoseltamab against standard treatment in adults with newly diagnosed multiple myeloma.
Key facts
- Who runs it
- European Myeloma Network B.V.
- Where
- Tallinn and Tartu Linn, EstoniaSee the 2 sitesAlso in 18 other countries, 77 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,000 people, planned
- Started
- 23 Dec 2025
- Expected to end
- Dec 2036
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Linvoseltamab
- Daratumumab
- Lenalidomide
- Dexamethasone
- Record updated
- 25 March 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 newly diagnosed multiple myeloma with symptoms who cannot have a stem cell transplant with their own cells.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed symptomatic multiple myeloma, with measurable disease. Not a candidate for high-dose chemotherapy and autologous stem cell transplant.
- Earlier treatment
- No earlier treatment for MGUS, smoldering myeloma or myeloma, except focal radiation or a short course of corticosteroids as defined in the protocol. No investigational drug or cell therapy with known or suspected activity against myeloma.
Main reasons for not taking part
- IMWG Frailty Index of 2, unless the score of 2 is based on age alone
- Choosing to put off a transplant by personal preference
- Non-secretory myeloma, active plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia or POEMS syndrome
- Myeloma in the brain or meninges, or a history of seizure, TIA or stroke within 12 months
- Earlier allogeneic stem cell transplant or solid organ transplant
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time; NOTE Other protocol defined inclusion/exclusion criteria apply
- International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which of these best describes your myeloma treatment so far?
- Has a doctor told you that your myeloma can be measured in your blood or urine tests?
- Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?
Where in Estonia
Also in 18 other countries, 77 sites
- North Estonia Medical Centre FoundationTallinn, EstoniaTaking people
- Tartu University HospitalTartu Linn, EstoniaTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
The 2 groups in the trial
- Control arm DRdExisting treatment, for comparison
Treatment: Daratumumab, Lenalidomide, and Dexamethasone
- Experimental Arm DRd+ linvolsetamabTreatment being tested
Treatment: Linvoseltamab, Daratumumab, Lenalidomide, and Dexamethasone
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 Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
- Plain-language title
- Tests linvoseltamab against standard treatment in 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 12 November 2026.
- Fit questions
- Built from NCT06932562, who can take part
- Record updated
- 25 March 2026