Compares linvoseltamab, alone or with carfilzomib, against standard treatments for relapsed myeloma
Tests linvoseltamab, alone or with carfilzomib, in adults with relapsed or refractory multiple myeloma.
Key facts
- Who runs it
- Regeneron Pharmaceuticals
- Where
- Dresden, Hamburg, Luebeck, Mainz, Mutlangen, Regensburg, and Wuerzburg, GermanySee the 8 sitesAlso in 17 other countries, 113 sites
- Trial code
- Registry title
- A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 915 people, planned
- Started
- 2 Jan 2026
- Expected to end
- 23 Aug 2034
- Type of study
- Interventional, 5 groups
- Treatments tested
- Linvoseltamab
- Carfilzomib
- Daratumumab
- Dexamethasone
- Pomalidomide
- Bortezomib
- 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 whose multiple myeloma came back or stopped responding, after 1 to 3 earlier lines of treatment. It compares linvoseltamab, alone or with carfilzomib, to standard treatments.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma that came back or did not respond (relapsed/refractory), with confirmed worsening (progressive disease) during or after the most recent treatment.
- Earlier treatment
- 1 to 3 earlier lines of therapy, which must have included lenalidomide and either a protease inhibitor (PI) or an anti-CD38 monoclonal antibody.
Main reasons for not taking part
- Earlier T cell-based immunotherapy aimed at BCMA (such as bispecific antibodies, BiTEs or CAR T cells)
- Plasma cell leukemia, symptomatic amyloidosis, Waldenström macroglobulinemia or POEMS syndrome
- Known myeloma in the central nervous system, including the meninges
- History of a neurodegenerative condition, PML or a CNS movement disorder
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
- Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy
Who cannot take part
- Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
- Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder; NOTE: Other protocol defined inclusion/exclusion criteria apply
- Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
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?
- Have you ever taken lenalidomide (also called Revlimid), a tablet medicine for myeloma?
- 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 Germany
Also in 17 other countries, 113 sites
- Gemeinschaftspraxis Haematologie OnkologieDresden, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- University Medical Center Hamburg-EppendorfHamburg, GermanyNot yet recruiting
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyNot yet recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyNot yet recruiting
- Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen RechtsMutlangen, GermanyNot yet recruiting
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyNot yet recruiting
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyNot yet recruiting
About the trial
What the trial wants to find out
This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.
Read full original descriptionShow less
The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.
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 5 groups in the trial
- Part 1: Arm ATreatment being tested
Treatment: Linvoseltamab
- Part 1: Arm BTreatment being tested
Treatment: Linvoseltamab and Carfilzomib
- Part 2: Arm ATreatment being tested
Treatment: Linvoseltamab
- Part 2: Arm BTreatment being tested
Treatment: Linvoseltamab and Carfilzomib
- Part 2: Arm CTreatment being tested
Treatment: Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide, and Bortezomib
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
- An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma
- Plain-language title
- Compares linvoseltamab, alone or with carfilzomib, against standard treatments for relapsed 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 NCT07222761, who can take part
- Record updated
- 4 November 2026