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NCT05083169Active, not recruitingPhase 3

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
587 (actual)
First submitted
8 Oct 2021
Start date
14 Oct 2021
Primary completion date
1 Aug 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05083169
EU CT number
2023-503441-55-00
EudraCT number
2020-004742-11

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 587
  • From 14 Oct 2021 to the primary completion date, 1 Aug 2025
  • 171 sites in 21 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

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:
    • A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,
    • A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization
  • Received a live, attenuated vaccine within 4 weeks before randomization

Other illness

  • Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
  • Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Who the study is looking for

  • Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
  • Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
  • Have clinical laboratory values within the specified range

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

Full criteria on ClinicalTrials.gov

Sites (171)

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

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Hospital Alemán
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CABAArgentinaUnknown status
Hospital Privado Centro Medico de Cordoba
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CórdobaArgentinaUnknown status
Ziekenhuis Aan De Stroom
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AntwerpBelgiumActive, not recruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumActive, not recruiting
Chu Helora
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La LouvièreBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Hospitais Integradaos da Gavea S/A - DF Star
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BrasíliaBrazilUnknown status
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
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CuritibaBrazilUnknown status
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
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FlorianópolisBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Rio de JaneiroBrazilUnknown status
IDOR - Regional Bahia
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SalvadorBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Instituto D'Or de Pesquisa e Ensino (IDOR)
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São PauloBrazilUnknown status
Clinica Medica Sao Germano LTDA
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São PauloBrazilUnknown status
Hospital Paulistano
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São PauloBrazilUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
QEII Health Sciences
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HalifaxCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
BC Cancer Agency - Vancouver BC
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VancouverCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital of Central Sourth University
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ChangshashiChinaUnknown status
Beijing Chaoyang Hospital
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Chaoyang DistrictChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Fujian Meidical University Union Hospital
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FuzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
First affiliated Hospital of Zhejiang University 1
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HangzhouChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
First Affiliated Hospital of Guangxi Medical University
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NanningChinaUnknown status
Shanghai Zhongshan Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
St. Barbara-Klinik Hamm GmbH
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HammGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Lillebaelt Hospital
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VejleDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario de Cabueñes
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GijónSpainActive, not recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, 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
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceActive, not recruiting
Blackpool Teaching Hospitals NHS Foundation Trust
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BlackpoolUnited KingdomUnknown status
Ninewells Hospital & Medical School
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DundeeUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust
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PlymouthUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceActive, not recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
University Hospital Consorziale Policlinico
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BariItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Fukuoka University Hospital
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FukuokaJapanUnknown status
Ogaki Municipal Hospital
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GifuJapanUnknown status
National Hospital Organization Mito Medical Center
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Higashiibaraki-gunJapanUnknown status
Tokai University Hospital
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IseharaJapanUnknown status
Shonan Kamakura General Hospital
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Kamakura-shiJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Dokkyo Medical University Saitama Medical Center
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KoshigayaJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
National Hospital Organization Matsumoto Medical Center
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MatsumotoJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Hyogo Medical University Hospital
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Nishinomiya-shiJapanUnknown status
National Hospital Organization Okayama Medical Center
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OkayamaJapanUnknown status
National Hospital Organization Hiroshima-Nishi Medical Center
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ŌtakeJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
National Hospital Organization Sendai Medical Center
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SendaiJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya-kuJapanUnknown status
Iwate Medical University Hospital
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Shiwa-gunJapanUnknown status
Kyungpook National University Hospital
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DaeguSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Stichting Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
St. Antonius Ziekenhuis
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NieuwegeinNetherlandsActive, not recruiting
Stichting Radboud Universitair Medisch Centrum
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NijmegenNetherlandsActive, not recruiting
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandActive, not recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandActive, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandActive, not recruiting
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
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WalbrzychPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
S.P. Botkin Moscow City Clinical Hospital 1
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MoscowRussiaUnknown status
S.P. Botkin Moscow City Clinical Hospital
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MoscowRussiaUnknown status
Clinical Research Institute of Hematology and Transfusiology
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Saint PetersburgRussiaUnknown status
Region Dalarna
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FalunSwedenActive, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GothenburgSwedenActive, not recruiting
Region Skane Helsingborg Hospital
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HelsingborgSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Region Vaesterbotten
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UmeaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Emory University/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
University of Alabama Birmingham
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BirminghamUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
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MadisonUnited StatesUnknown status
Baptist Cancer Center
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MemphisUnited StatesUnknown status
Vanderbilt-Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
West Penn Hospital
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PittsburghUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Henry Ford Health System
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SouthfieldUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status
Ankara University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Ondokuz Mayis University
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AtakumTurkey (Türkiye)Unknown status
Medipol University Hospital
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul University Medical Faculty
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IzmirTurkey (Türkiye)Unknown status

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