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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
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

Full criteria on ClinicalTrials.gov

Sites (121)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaNot yet recruiting
Johannes Kepler University Linz
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LinzAustriaNot yet recruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaNot yet recruiting
Hanusch Krankenhaus der Wiener Gebietskrankenkasse
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ViennaAustriaNot yet recruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaNot yet recruiting
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Pindara Private Hospital
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BenowaAustraliaRecruiting
Mater Misericordiae Ltd.
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BrisbaneAustraliaRecruiting
Epworth Freemasons
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East MelbourneAustraliaRecruiting
Austin Hospital
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HeidelbergAustraliaRecruiting
Alfred Hospital
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MelbourneAustraliaRecruiting
Royal Perth Hospital
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PerthAustraliaRecruiting
Gold Coast Hospital and Health Service
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SouthportAustraliaRecruiting
Ziekenhuis Aan De Stroom
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AntwerpBelgiumNot yet recruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumNot yet recruiting
Ziekenhuis Oost-Limburg
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GenkBelgiumNot yet recruiting
UZ Brussel
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JetteBelgiumNot yet recruiting
CHC MontLégia
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LiègeBelgiumNot yet recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumNot yet recruiting
Cetus Oncologia
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Belo HorizonteBrazilRecruiting
Hospital Erasto Gaertner
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CuritibaBrazilRecruiting
Centro de Hematologia e Oncologia
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JoinvilleBrazilRecruiting
ANIMI
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LagesBrazilRecruiting
Oncomed Clínica Oncológica
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NiteróiBrazilRecruiting
Centro Gaúcho Integrado - Hospital Mae de Deus
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Porto AlegreBrazilRecruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilRecruiting
Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo
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Ribeirão PretoBrazilRecruiting
AC Camargo Cancer Center
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São PauloBrazilRecruiting
Clinica Medica Sao Germano
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São PauloBrazilRecruiting
Hospital Clinico Universidad de Los Andes
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SantiagoChileRecruiting
Clínica UC San Carlos de Apoquindo
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SantiagoChileRecruiting
Clinica Alemana de Santiago
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SantiagoChileRecruiting
OncoPrecision
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SantiagoChileRecruiting
Centro de Investigaciones Clinicas Vina Del Mar
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Viña del MarChileRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaNot yet recruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaNot yet recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaNot yet recruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyNot yet recruiting
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
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MutlangenGermanyNot yet recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainNot yet recruiting
Hospital Universitario de Cabueñes
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GijónSpainNot yet recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainNot yet recruiting
Hospital Universitari Mutua Terrassa
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TerrassaSpainNot yet recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainNot yet recruiting
Centre Hospitalier Victor Dupouy
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Argenteuil CedexFranceNot yet recruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceNot yet recruiting
Centre Leon Berard
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LyonFranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceNot yet recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceNot yet recruiting
CHRU De Nancy
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Vandoeuvre Les Nancy CedexFranceNot yet recruiting
Institut Gustave Roussy
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VillejuifFranceNot yet recruiting
Aberdeen Royal Infirmary
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AberdeenUnited KingdomRecruiting
University Hospitals Birmingham NHS Trust, Center for Clinical
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BirminghamUnited KingdomRecruiting
Ninewells Hospital and Medical School
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DundeeUnited KingdomRecruiting
University of Manchester, Manchester Royal Infirmary
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ManchesterUnited KingdomRecruiting
Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
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NorwichUnited KingdomRecruiting
University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
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PlymouthUnited KingdomRecruiting
The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital
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SuttonUnited KingdomRecruiting
Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
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TruroUnited KingdomRecruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceNot yet recruiting
Evangelismos S A
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AthensGreeceNot yet recruiting
General Hospital of Athens - Alexandra
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AthensGreeceNot yet recruiting
University General Hospital of Ioannina
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IoanninaGreeceNot yet recruiting
Olympion Therapeftirio General Clinic Of Patras S.A.
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PatraGreeceNot yet recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceNot yet recruiting
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
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BariItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyNot yet recruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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CandioloItalyNot yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
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MilanItalyNot yet recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyNot yet recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyNot yet recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyNot yet recruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
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SalernoItalyNot yet recruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyNot yet recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
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VareseItalyNot yet recruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital; Division of Hematology
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SeoulSouth KoreaRecruiting
Ulsan University Hospital
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UlsanSouth KoreaRecruiting
Amphia Hospital
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BredaNetherlandsNot yet recruiting
Spaarne Gasthuis Stichting
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HoofddorpNetherlandsNot yet recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsNot yet recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandNot yet recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandNot yet recruiting
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
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WalbrzychPolandNot yet recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandNot yet recruiting
Kaohsiung Medical University Hospital
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Kaohsiung CityTaiwanRecruiting
Taichung Veterans General Hospital
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TaichungTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipei Municipal Wan Fang Hospital
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TaipeiTaiwanRecruiting
Chang Gung Memorial Hospital, Linkou Branch
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TaoyuanTaiwanRecruiting
Emory Winship Cancer Institute
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AtlantaUnited StatesRecruiting
OhioHealth
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ColumbusUnited StatesRecruiting
Baylor University Medical Center
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DallasUnited StatesRecruiting
University of Texas Health Science Center, Houston
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HoustonUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Stony Brook University Hospital
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Stony BrookUnited StatesRecruiting
Ankara Liv Hospital
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AnkaraTurkey (Türkiye)Recruiting
Istanbul Florence Nightingale Hospital
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IstanbulTurkey (Türkiye)Recruiting
Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)
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IzmirTurkey (Türkiye)Recruiting
Ankara University Faculty of Medicine
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MamakTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.