NCT07222761RecruitingPhase 3
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)
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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. 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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 915 (estimated)
- First submitted
- 28 Oct 2025
- Start date
- 2 Jan 2026
- Primary completion date
- 21 May 2029
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Multiple myeloma
- NCT number
- NCT07222761
- EU CT number
- 2024-519504-27-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 915
- From 2 Jan 2026 to the primary completion date, 21 May 2029
- 121 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (121)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Not yet recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Not yet recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Klinikum Wels-Grieskirchen GmbH Coordinator of this site? Confirm its status | Wels | Austria | Not yet recruiting |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Pindara Private Hospital Coordinator of this site? Confirm its status | Benowa | Australia | Recruiting |
| Mater Misericordiae Ltd. Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Epworth Freemasons Coordinator of this site? Confirm its status | East Melbourne | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Gold Coast Hospital and Health Service Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Not yet recruiting |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Not yet recruiting |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Not yet recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Not yet recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Not yet recruiting |
| Cetus Oncologia Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Hospital Erasto Gaertner Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Centro de Hematologia e Oncologia Coordinator of this site? Confirm its status | Joinville | Brazil | Recruiting |
| ANIMI Coordinator of this site? Confirm its status | Lages | Brazil | Recruiting |
| Oncomed Clínica Oncológica Coordinator of this site? Confirm its status | Niterói | Brazil | Recruiting |
| Centro Gaúcho Integrado - Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| AC Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Clinica Medica Sao Germano Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital Clinico Universidad de Los Andes Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Clínica UC San Carlos de Apoquindo Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Clinica Alemana de Santiago Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| OncoPrecision Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Centro de Investigaciones Clinicas Vina Del Mar Coordinator of this site? Confirm its status | Viña del Mar | Chile | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Not yet recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Not yet recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Coordinator of this site? Confirm its status | Mutlangen | Germany | Not yet recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Not yet recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Not yet recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Not yet recruiting |
| Hospital Universitari Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Not yet recruiting |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Centre Hospitalier Victor Dupouy Coordinator of this site? Confirm its status | Argenteuil Cedex | France | Not yet recruiting |
| Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Not yet recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy Cedex | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| Aberdeen Royal Infirmary Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Recruiting |
| University Hospitals Birmingham NHS Trust, Center for Clinical Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Ninewells Hospital and Medical School Coordinator of this site? Confirm its status | Dundee | United Kingdom | Recruiting |
| University of Manchester, Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Royal Cornwall Hospital National Health Service (NHS) Foundation Trust Coordinator of this site? Confirm its status | Truro | United Kingdom | Recruiting |
| University General Hospital of Alexandroupoli Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Not yet recruiting |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Not yet recruiting |
| Olympion Therapeftirio General Clinic Of Patras S.A. Coordinator of this site? Confirm its status | Patra | Greece | Not yet recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Not yet recruiting |
| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Not yet recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Not yet recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul St. Mary's Hospital, The Catholic University of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital; Division of Hematology Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Not yet recruiting |
| Spaarne Gasthuis Stichting Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Not yet recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Coordinator of this site? Confirm its status | Walbrzych | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Kaohsiung Medical University Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Municipal Wan Fang Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Emory Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| OhioHealth Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas Health Science Center, Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Stony Brook University Hospital Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| Ankara Liv Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Florence Nightingale Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
| Ankara University Faculty of Medicine Coordinator of this site? Confirm its status | Mamak | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.