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NCT05455320Active, not recruitingPhase 3

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
864 (actual)
First submitted
22 Jun 2022
Start date
13 Oct 2022
Primary completion date
30 Jul 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05455320
EU CT number
2023-503467-41-00
EudraCT number
2021-000202-22

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 864
  • From 13 Oct 2022 to the primary completion date, 30 Jul 2027
  • 200 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

  • Received prior pomalidomide therapy
  • A maximum cumulative dose of corticosteroids to \>=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug

Other illness

  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
  • Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
  • Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Other

  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Who the study is looking for

  • Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
  • Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
  • Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment

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

Full criteria on ClinicalTrials.gov

Sites (200)

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

SiteCityCountrySite status
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumActive, not recruiting
UZ Brussel
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JetteBelgiumActive, not recruiting
CHC MontLégia
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LiègeBelgiumActive, not recruiting
Clinique Saint Pierre
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Ottignies-Louvain-la-NeuveBelgiumActive, not recruiting
Fundacao Pio XII
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BarretosBrazilUnknown status
Santa Casa de Misericordia de Belo Horizonte
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Belo HorizonteBrazilUnknown status
IDOR - Regional Brasilia
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BrasíliaBrazilUnknown status
Fundacao Universidade de Caxias Do Sul
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Caxias do SulBrazilUnknown status
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
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CuritibaBrazilUnknown status
Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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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
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Ribeirão PretoBrazilUnknown 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
IDOR - Regional Sao Paulo
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São PauloBrazilUnknown status
Hospital Paulistano
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São PauloBrazilUnknown status
Clinica Medica Sao Germano LTDA
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Beijing Chaoyang Hospital
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Chaoyang DistrictChinaUnknown status
Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Shanghai Fourth People's Hospital
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ShanghaiChinaUnknown status
Tongji Hospital of Tongji University
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ShanghaiChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
First Affiliated Hospital SooChow University
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SuzhouChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
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TianjinChinaUnknown status
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
Hospital Universitario De Canarias
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La LagunaSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Hopital Saint Antoine
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Paris Cedex 12FranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceActive, not recruiting
Blackpool Victoria Hospital
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BlackpoolUnited KingdomUnknown status
Ninewells Hospital & Medical School
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DundeeUnited KingdomUnknown status
Hammersmith Hospital
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LondonUnited KingdomUnknown status
Newcastle Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust
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PlymouthUnited KingdomUnknown status
Royal Marsden Hospital
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SuttonUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
Ha'Emek Medical Center
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AfulaIsraelUnknown status
Shamir Medical Center Assaf Harofeh
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Be’er Ya‘aqovIsraelUnknown status
Hillel Yaffe Medical Center
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HaderaIsraelUnknown status
Bnai Zion Medical Center
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HaifaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Galilee Medical Center
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NahariyaIsraelUnknown status
Beilinson medical center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Ziv Medical Center
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SafedIsraelUnknown status
Sourasky (Ichilov) Medical Center
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
University Hospital Consorziale Policlinico
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BariItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Azienda Ospedaliera di Padova
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, 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 Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Institute of Science Tokyo Hospital
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Bunkyō CityJapanUnknown status
Chiba Cancer Center
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ChibaJapanUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Ogaki Municipal Hospital
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GifuJapanUnknown status
Gunma University Hospital
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GunmaJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Japanese Red Cross Society Himeji Hospital
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HyōgoJapanUnknown 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
Kyoto Kuramaguchi Medical Center
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KyotoJapanUnknown status
National Hospital Organization Matsumoto Medical Center
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MatsumotoJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Hyogo Medical University Hospital
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Nishinomiya-shiJapanUnknown status
National Hospital Organization Hiroshima-Nishi Medical Center
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ŌtakeJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Iwate Medical University Hospital
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Shiwa-gunJapanUnknown status
The University of Osaka Hospital
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SuitaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
National Cancer Center
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Gyeonggi-doSouth 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
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth 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
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Maxima Medisch Centrum
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VeldhovenNetherlandsActive, not recruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandActive, 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
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
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SzczecinPolandActive, not recruiting
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
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TorunPolandActive, 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
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
University of Michigan Health System
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Ann ArborUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
Boston University Medical Center
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BostonUnited StatesUnknown status
Massachusetts General
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BostonUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Levine Cancer Institute, Carolinas HealthCare System
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CharlotteUnited StatesUnknown status
Novant Health 1
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CharlotteUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
The Ohio State University Wexner Medical Center - James Cancer Hospital
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ColumbusUnited StatesUnknown status
OhioHealth
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ColumbusUnited StatesUnknown status
Memorial Healthcare System
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HollywoodUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Joe Arrington Cancer Research Treatment Center
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LubbockUnited StatesUnknown status
Baptist Cancer Center
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MemphisUnited StatesUnknown status
University of Miami Health System
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MiamiUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Ochsner Health System
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New OrleansUnited StatesUnknown status
Tulane University Hospital & Clinics
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New OrleansUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
Norwalk Hospital-oncology
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NorwalkUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Virginia Commonwealth University/Massey Cancer Center
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RichmondUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
The University of Arizona Cancer Center
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TucsonUnited StatesUnknown status
George Washington University
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Washington D.C.United StatesUnknown status
MedStar Georgetown University Hospital
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Washington D.C.United StatesUnknown status
University of Kansas
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WestwoodUnited StatesUnknown status
Wake Forest Baptist Medical Center
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Winston-SalemUnited StatesUnknown status
Novant Health
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Winston-SalemUnited StatesUnknown status
University of Massachusetts Medical School
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WorcesterUnited StatesUnknown status
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Unknown status
Ankara University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
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AnkaraTurkey (Türkiye)Unknown status
Antalya Egitim ve Arastirma Hastanesi
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AntalyaTurkey (Türkiye)Unknown status
Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Medipol Mega University Hospital
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Istanbul Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul University Medical Faculty
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IzmirTurkey (Türkiye)Unknown status
Ondokuz Mayis University
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SamsunTurkey (Türkiye)Unknown status

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