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NCT05572515Active, not recruitingPhase 3

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
614 (actual)
First submitted
5 Oct 2022
Start date
29 Mar 2023
Primary completion date
13 Oct 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05572515
EU CT number
2023-503444-13-00
EudraCT number
2022-000928-37

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 614
  • From 29 Mar 2023 to the primary completion date, 13 Oct 2025
  • 202 sites in 24 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 any prior B cell maturation antigen (BCMA)-directed therapy
  • A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic blood pressure \>99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade \>=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[AE\] related to carfilzomib)
  • Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization
  • Received a live, attenuated vaccine within 4 weeks before randomization

Other illness

  • Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis

Other

  • Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma

Who the study is looking for

  • Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to 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 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  • Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

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

Full criteria on ClinicalTrials.gov

Sites (202)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaActive, not recruiting
Blacktown Hospital
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BlacktownAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Box Hill Hospital
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Algemeen Ziekenhuis klina
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BrasschaatBelgiumActive, 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
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumActive, not recruiting
Hospitais Integradaos da Gavea S/A - DF Star
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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
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
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JoinvilleBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Complexo Hospitalar de Niteroi
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NiteróiBrazilUnknown 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
Funfarme Sjrp
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São José do Rio PretoBrazilUnknown status
Real e Benemerita Associacao Portuguesa de Beneficencia
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São PauloBrazilUnknown status
Hospital Alemão Oswaldo Cruz
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
IDOR - Regional Sao Paulo
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São PauloBrazilUnknown status
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São PauloBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilUnknown status
Clinica Medica Sao Germano LTDA
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São PauloBrazilUnknown status
Brampton Civic Hospital
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BramptonCanadaUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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MontrealCanadaUnknown status
Lakeridge Health Oshawa
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OshawaCanadaUnknown status
Saint John Regional Hospital
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Saint JohnCanadaUnknown status
Beijing Jishuitan Hospital
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BeijingChinaUnknown status
Beijing ChaoYang Hospital
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
The Third Xiangya Hospital, Central South University
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ChangshaChinaUnknown status
Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown 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
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HangzhouChinaUnknown status
First affiliated Hospital of Zhejiang University 1
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
First Affiliated Hospital of Guangxi Medical University
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NanningChinaUnknown status
Shanghai Fourth People's Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Shenzhen 2nd People's Hospital
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ShenzhenChinaUnknown status
Institute of Hematology and Blood Diseases Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Wuhan Union Hospital
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Carl-Thiem-Klinikum Cottbus gGmbH
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CottbusGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyActive, not recruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Heinrich-Braun-Klinikum Zwickau gGmbH
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ZwickauGermanyActive, 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
Region Midtjylland
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HerningDenmarkActive, not recruiting
Sygehus Lillebaelt - Vejle Sygehus
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VejleDenmarkActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Infanta Leonor
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
Hospital Son Llatzer
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PalmaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceActive, not recruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
CHRU De Nancy
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Nancy CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hopital Saint Antoine
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Paris Cedex 12FranceActive, not recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
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ToulouseFranceActive, not recruiting
Aberdeen Royal Infirmary
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AberdeenUnited KingdomUnknown status
University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Colchester Hospital University NHS
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ColchesterUnited KingdomUnknown status
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomUnknown status
St Georges Hospital
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LondonUnited KingdomUnknown status
Chelsea And Westminster Hospital
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LondonUnited KingdomUnknown status
James Cook University Hospital
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MiddlesbroughUnited KingdomUnknown status
Norfolk and Norwich University Hospital
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NorwichUnited KingdomUnknown status
Royal Stoke University Hospital
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StaffordshireUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceActive, not recruiting
General Hospital Of Patras Agios Andreas
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PatrasGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
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
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Fortis Memorial Research Institute
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GūrgaonIndiaUnknown status
Bhagwan Mahaveer Cancer Hospital & Research Centre
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JaipurIndiaUnknown status
Deenanath Mangeshkar Hospital and Research Centre
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PuneIndiaUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Senese
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SienaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
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VareseItalyActive, not recruiting
Institute of Science Tokyo Hospital
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Bunkyō CityJapanUnknown status
Chiba Cancer Center
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ChibaJapanUnknown status
Ogaki Municipal Hospital
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GifuJapanUnknown status
National Hospital Organization Shibukawa Medical Center
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GunmaJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Hitachi General Hospital
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HitachiJapanUnknown status
Saitama Medical University Hospital
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Iruma-gunJapanUnknown status
Kameda Medical Center
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KamogawaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Kurashiki Central Hospital
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KurashikiJapanUnknown status
Matsuyama Red Cross Hospital
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MatsuyamaJapanUnknown status
Aichi Medical University Hospital
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NagakuteJapanUnknown status
JRC Nagasaki Genbaku Hospital
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NagasakiJapanUnknown status
Niigata University Medical and Dental Hospital
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NiigataJapanUnknown status
National Hospital Organization Okayama Medical Center
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OkayamaJapanUnknown status
Osaka Metropolitan University Hospital
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OsakaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Juntendo University Hospital
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TokyoJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Yamagata University Hospital
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YamagataJapanUnknown status
Yamanashi Prefectural Central Hospital
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YamanashiJapanUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Queen Elizabeth
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Kota KinabaluMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Subang Jaya Medical Centre
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Subang JayaMalaysiaUnknown status
Meander Medisch Centrum
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AmersfoortNetherlandsActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, 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
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalActive, not recruiting
Region Dalarna
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FalunSwedenActive, not recruiting
Region Skane Helsingborg Hospital
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HelsingborgSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesUnknown status
Rocky Mountain Cancer Centers
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AuroraUnited StatesUnknown status
Alta Bates Comprehensive Cancer Center
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BerkeleyUnited StatesUnknown status
Walter Reed National Military Medical Center
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BethesdaUnited StatesUnknown status
Boston University Medical Center
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BostonUnited StatesUnknown status
Cooper Health System MD Anderson Cancer Center at Cooper
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CamdenUnited StatesUnknown status
Saint Lukes Hospital Saint Lukes Cancer Specialists
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ChesterfieldUnited StatesUnknown status
Durham VAMC
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DurhamUnited StatesUnknown status
University of Connecticut
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FarmingtonUnited StatesUnknown status
Alexander T. Augusta Military Medical Center
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Fort BelvoirUnited StatesUnknown status
Brooke Army Medical Center
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Fort Sam HoustonUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
Michael E. DeBakey VA Medical Center
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HoustonUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Harris Health Smith Clinic
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HoustonUnited StatesUnknown status
Penn Medicine Lancaster General Health
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LancasterUnited StatesUnknown status
MemorialCare Long Beach Medical Center
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Long BeachUnited StatesUnknown status
East Jefferson General Hospital Bone Marrow Transport Clinic
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MetairieUnited StatesUnknown status
University of Miami - Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New YorkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
University of California Irvine
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OrangeUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
Utah Cancer Specialists
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Salt Lake CityUnited StatesUnknown status
Maryland Oncology Hematology P.A.
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Silver SpringUnited StatesUnknown status
Northwest Medical Specialties PLLC
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TacomaUnited StatesUnknown status
Mission Cancer Blood
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WaukeeUnited StatesUnknown status
Cleveland Clinic Florida
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WestonUnited StatesUnknown status
PIH Health Hospital
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WhittierUnited StatesUnknown status
Ankara Gulhane Training and Research Hospital
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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
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AnkaraTurkey (Türkiye)Unknown status
Liv Hospital Ankara
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AnkaraTurkey (Türkiye)Unknown status
Antalya Training and Research Hospital
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AntalyaTurkey (Türkiye)Unknown status
Pamukkale University Medical Faculty
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DenizliTurkey (Türkiye)Unknown status
Medipol Mega Universite Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Ondokuz Mayis University
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SamsunTurkey (Türkiye)Unknown status

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