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NCT05730036RecruitingPhase 3

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
410 (estimated)
First submitted
6 Feb 2023
Start date
18 Sept 2023
Primary completion date
19 Apr 2033
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT05730036
EU CT number
2022-501396-62-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 410
  • From 18 Sept 2023 to the primary completion date, 19 Apr 2033
  • 150 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 elotuzumab and/or pomalidomide
  • Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
  • History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
  • Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
  • Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug

Other illness

  • Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).

Lab values

  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.
    • NOTE: Other protocol defined inclusion/exclusion criteria apply

Other

  • Participants with known MM brain lesions or meningeal involvement

Who the study is looking for

  • Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
  • Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.
    • Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.
  • Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
  • Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
  • Life expectancy of at least 6 months

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (150)

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

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaActive, not recruiting
ICON Cancer Centre Wesley
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AuchenflowerAustraliaActive, not recruiting
Royal Prince Alfred Hospital
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CamperdownAustraliaActive, not recruiting
St. Vincent's Hospital
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FitzroyAustraliaActive, not recruiting
University Hospital Geelong
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GeelongAustraliaActive, not recruiting
Austin Hospital
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HeidelbergAustraliaActive, not recruiting
Royal Brisbane and Women's Hospital
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HerstonAustraliaActive, not recruiting
Royal Hobart Hospital
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HobartAustraliaActive, not recruiting
Launceston General Hospital
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LauncestonAustraliaActive, not recruiting
One Clinical Research at Hollywood Private Hospital
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NedlandsAustraliaActive, not recruiting
Royal North Shore Hospital
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St LeonardsAustraliaActive, not recruiting
Ziekenhuis Aan De Stroom
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AntwerpBelgiumActive, not recruiting
AZ Delta
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RoeselareBelgiumActive, not recruiting
Associacao Dr. Bartholomeu Tacchini
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Bento GonçalvesBrazilActive, not recruiting
Hospital Erasto Gaertner
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CuritibaBrazilActive, not recruiting
ANIMI - Unidade de Tratamento Oncológico
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LagesBrazilActive, not recruiting
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilActive, not recruiting
Centro Gaucho Integrado
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Porto AlegreBrazilActive, not recruiting
Instituto Americas de Ensino e Pesquisa
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Rio de JaneiroBrazilActive, not recruiting
IDOR - Sao Rafael Salvador Bahia
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SalvadorBrazilActive, not recruiting
Instituto Dor de Pesquisa E Ensino
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São PauloBrazilActive, not recruiting
A Beneficencia Portuguesa de Sao Paulo, Oncology House
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São PauloBrazilActive, not recruiting
AC Camargo Cancer Center
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São PauloBrazilActive, not recruiting
Clinica Medica Sao Germano
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São PauloBrazilActive, not recruiting
The Ottawa Hospital Cancer Centre
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OttawaCanadaActive, not recruiting
University Health Network - Princess Margaret Cancer Center
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TorontoCanadaActive, not recruiting
Sunnybrook Health Sciences Centre
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TorontoCanadaActive, not recruiting
Hospital Clinico Universidad de Los Andes
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SantiagoChileActive, not recruiting
Clinica Alemana de Santiago
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SantiagoChileActive, not recruiting
Fundacion Arturo Lopez Perez
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SantiagoChileActive, not recruiting
Clínica UC San Carlos de Apoquindo
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SantiagoChileActive, not recruiting
Centro Oncologia de Precision Universidad Mayor
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SantiagoChileActive, not recruiting
Centro de Investigaciones Clinicas Vina Del Mar
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Viña del MarChileActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
University Medical Centre Schleswig-Holstein
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LübeckGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Hospital General Universitario de Alicante
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AlicanteSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario de Cabueñes
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GijónSpainActive, not recruiting
Institut Català d'Oncologia
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GironaSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Catalan Institute of Oncology
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
University Clinic of Navarra
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Son Llatzer Hospital
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Palma De MallorcaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
University Clinic of Navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainActive, not recruiting
Hospital Universitari Mutua Terrassa
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TerrassaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Universitario Araba
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VitoriaSpainActive, not recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomActive, not recruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomActive, not recruiting
Western General Hospital
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EdinburghUnited KingdomActive, not recruiting
Hammersmith Hospital
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LondonUnited KingdomActive, not recruiting
Barts Health NHS Trust
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LondonUnited KingdomActive, not recruiting
Royal Marsden Hospital
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LondonUnited KingdomActive, not recruiting
Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomActive, not recruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomWithdrawn
Lady Davis Carmel Medical Center
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HaifaIsraelActive, not recruiting
Rambam Health Care Campus
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HaifaIsraelActive, not recruiting
Shaare Zedek Medical Center
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JerusalemIsraelActive, not recruiting
Hadassah medical Center
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JerusalemIsraelActive, not recruiting
Sheba medical center
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Ramat GanIsraelActive, not recruiting
The Tel Aviv Sourasky Medical Center
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Tel AvivIsraelActive, not recruiting
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
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AlexandriaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
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CandioloItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyActive, not recruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
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VareseItalyActive, not recruiting
Chiba Cancer Center
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ChibaJapanRecruiting
Fukushima Medical University
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FukushimaJapanRecruiting
Saitama Medical University Hospital
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Iruma-gunJapanRecruiting
Kameda General Hospital
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KamogawaJapanRecruiting
National Cancer Center Hospital East
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Kashiwa-shiJapanRecruiting
National Hospital Organization Okayama Medical Center
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Kita-kuJapanRecruiting
Yamanashi Prefectural Central Hospital
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KofuJapanRecruiting
National Hospital Organization Kumamoto Medical Center
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KumamotoJapanRecruiting
Kurume University Hospital
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KurumeJapanRecruiting
Gunma University Hospital
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MaebashiJapanRecruiting
Aichi Medial University Hospital
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NagakuteJapanRecruiting
Ogaki Municipal Hospital
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ŌgakiJapanRecruiting
Sapporo Hokuyu Hospital
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SapporoJapanRecruiting
National Hospital Organization Sendai Medical Center
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SendaiJapanRecruiting
NHO Shibukawa Medical Center
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ShibukawaJapanRecruiting
Japanese Red Cross Medical Center
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Shibuya-kuJapanRecruiting
Iwate Medical University Hospital
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Shiwa-gunJapanRecruiting
Osaka University Hospital
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Suita-shiJapanRecruiting
Tokushima Prefectural Central Hospital
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TokushimaJapanRecruiting
Pusan National University Hospital
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BusanSouth KoreaActive, not recruiting
Inje University Busan Paik Hospital
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BusanSouth KoreaActive, not recruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaActive, not recruiting
Gachon University Gil Hospital
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IncheonSouth KoreaActive, not recruiting
jeonbuk National University Hospital
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JeonjuSouth KoreaActive, not recruiting
Seoul National University Hospital
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SeoulSouth KoreaActive, not recruiting
Samsung Medical Center
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SeoulSouth KoreaActive, not recruiting
Seoul St. Marys Hospital
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SeoulSouth KoreaActive, not recruiting
Asan Medical Center
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SeoulSouth KoreaActive, not recruiting
Severance hospital
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SeoulSouth KoreaActive, not recruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsActive, not recruiting
Stichting Radboud University Medical Center
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NijmegenNetherlandsActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Pratia Onkologia Katowice
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KatowicePolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandActive, not recruiting
Singapore General Hospital
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SingaporeSingaporeActive, not recruiting
National University Hospital
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SingaporeSingaporeActive, not recruiting
Changhua Christian Hospital
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ChanghuaTaiwanActive, not recruiting
Hualien Tzu Chi Hospital
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Hualien CityTaiwanActive, not recruiting
Kaohsiung Medical University Hospital
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Kaohsiung CityTaiwanActive, not recruiting
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanActive, not recruiting
Taichung Veterans General Hospital
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TaichungTaiwanWithdrawn
National Cheng Kung University Hospital
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TainanTaiwanActive, not recruiting
National Taiwan University Hospital
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TaipeiTaiwanActive, not recruiting
Tri-Service General Hospital
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TaipeiTaiwanActive, not recruiting
Wanfang Hospital
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TaipeiTaiwanActive, not recruiting
Chang Gung Memorial Hospital, Linkou Branch
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TaoyuanTaiwanActive, not recruiting
Levine Cancer Center
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CharlotteUnited StatesActive, not recruiting
Duke University Medical Center
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DurhamUnited StatesWithdrawn
University of Florida Division of Sponsored Programs
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GainesvilleUnited StatesWithdrawn
MD Anderson Cancer Center
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HoustonUnited StatesActive, not recruiting
University of Kentucky, Markey Cancer Center Clinical Research Organization
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LexingtonUnited StatesActive, not recruiting
University of California Los Angeles (UCLA).
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Los AngelesUnited StatesActive, not recruiting
Norton Cancer Institute
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LouisvilleUnited StatesActive, not recruiting
Kaiser Permanente Northwest
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PortlandUnited StatesActive, not recruiting
University of Washington
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SeattleUnited StatesActive, not recruiting
Stony Brook University
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Stony BrookUnited StatesActive, not recruiting

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