A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9)

Last Updated   August 15, 2024

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CR109244

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    202 Sites
  • Status
     Recruiting

SUMMARY

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) 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. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.

CONDITIONS

  • Relapsed or Refractory Multiple Myeloma

ELIGIBILITY


Inclusion Criteria:

* 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) Seru

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DETAILS

LOCATIONS

Locations in:
United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Spain, Sweden, Türkiye, United Kingdom
Country (24) City or Province (202) Status
United States Anchorage Alaska Oncology and Hematology LLC
COMPLETED
United States Berkeley Alta Bates Comprehensive Cancer Center
RECRUITING
United States Long Beach MemorialCare Long Beach Medical Center
RECRUITING
United States Orange University of California Irvine
RECRUITING
United States Whittier PIH Health Hospital
RECRUITING
United States Farmington University of Connecticut
RECRUITING
United States Miami University of Miami Sylvester Cancer Center
RECRUITING
United States Orlando Orlando Health Cancer Institute
RECRUITING
United States Weston Cleveland Clinic Florida
RECRUITING
United States Metairie East Jefferson General Hospital Bone Marrow Transport Clinic
SUSPENDED
United States Boston Boston University Medical Center
RECRUITING
United States Chesterfield Saint Lukes Hospital Saint Lukes Cancer Specialists
RECRUITING
United States Camden Cooper Health System MD Anderson Cancer Center at Cooper
RECRUITING
United States New York Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
RECRUITING
United States Durham Durham VAMC
RECRUITING
United States Lancaster Penn Medicine Lancaster General Health
RECRUITING
United States Fort Sam Houston Brooke Army Medical Center
RECRUITING
United States Houston Baylor College of Medicine
RECRUITING
United States Houston Harris Health Smith Clinic
RECRUITING
United States Salt Lake City Utah Cancer Specialists
RECRUITING
United States Fort Belvoir Alexander T. Augusta Military Medical Center
RECRUITING
Australia Blacktown Blacktown Hospital
RECRUITING
Australia Fitzroy St Vincents Hospital Melbourne
RECRUITING
Australia Melbourne Box Hill Hospital
RECRUITING
Australia Murdoch Fiona Stanley Hospital
RECRUITING
Australia Nedlands Sir Charles Gairdner Hospital
RECRUITING
Austria Salzburg LKH - Universitätsklinikum der PMU Salzburg
RECRUITING
Austria Vienna Medical University Vienna MUV
RECRUITING
Belgium Brasschaat Algemeen Ziekenhuis Klina
RECRUITING
Belgium Haine-St-Paul Jolimont
RECRUITING
Belgium Kortrijk Az Groeninge
RECRUITING
Belgium Leuven Universitair Ziekenhuis Gasthuisberg
RECRUITING
Belgium Liege CHR de la Citadelle
RECRUITING
Brazil Brasilia Hospitais Integradaos da Gavea S/A - DF Star
RECRUITING
Brazil Caxias do Sul Fundacao Universidade de Caxias do Sul
RECRUITING
Brazil Joinville Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
RECRUITING
Brazil Natal Liga Norte Riograndense Contra O Cancer
RECRUITING
Brazil Niteroi Complexo Hospitalar de Niteroi
RECRUITING
Brazil Rio de Janeiro Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
RECRUITING
Brazil Salvador Hospital Sao Rafael
RECRUITING
Brazil Sao Jose do Rio Preto Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
RECRUITING
Brazil Sao Paulo Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
RECRUITING
Brazil Sao Paulo Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Brazil Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
Brazil São Paulo Real e Benemérita Associação Portuguesa de Beneficência
RECRUITING
Brazil São Paulo Hospital Alemao Oswaldo Cruz
RECRUITING
Brazil São Paulo Clinica Sao Germano
RECRUITING
Brazil São Paulo Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
Canada Calgary Tom Baker Cancer Centre
RECRUITING
Canada Saint John Saint John Regional Hospital
RECRUITING
Canada Brampton Brampton Civic Hospital
RECRUITING
Canada Oshawa Lakeridge Health Oshawa
RECRUITING
Canada Montreal CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
RECRUITING
China Beijing Beijing Chaoyang Hospital
RECRUITING
China Beijing BeiJing JiShuiTan Hospital
RECRUITING
China Changchun The First Bethune Hospital of Jilin University
RECRUITING
China Changsha The Third Xiangya Hospital, Central South University
RECRUITING
China Chengdu Sichuan Provincial Peoples Hospital
RECRUITING
China Chongqing Chongqing University Cancer Hospital
RECRUITING
China Fu Zhou Fujian Meidical University Union Hospital
RECRUITING
China Guangzhou Sun Yat -Sen University Cancer Center
RECRUITING
China Hangzhou First affiliated Hospital of Zhejiang University
RECRUITING
China Harbin Harbin medical university cancer hospital
RECRUITING
China Nanchang The First Affiliated Hospital of NanChang University
RECRUITING
China Nanjing Nanjing Drum Tower Hospital
RECRUITING
China Nanning First Affiliated Hospital of Guangxi Medical University
RECRUITING
China Shanghai Shanghai Fourth People s Hospital
RECRUITING
China Shenyang Shengjing Hospital Of China Medical University
RECRUITING
China Shenzhen Shenzhen 2nd People's Hospital
RECRUITING
China Tian Jin Institute of Hematology and Blood Diseases Hospital
RECRUITING
China Tianjin Tianjin Medical University Cancer Institute and Hospital
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
China Wuhan Wuhan Union Hospital
RECRUITING
China Xi'an The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
China Zhengzhou Henan Cancer Hospital
RECRUITING
Czechia Brno Fakultni nemocnice Brno
RECRUITING
Czechia Olomouc Fakultni nemocnice Olomouc
RECRUITING
Czechia Ostrava - Poruba Fakultni Nemocnice Ostrava
RECRUITING
Czechia Praha 2 Vseobecna fakultni nemocnice v Praze
RECRUITING
Denmark Aalborg Aalborg University Hospital
RECRUITING
Denmark Aarhus Aarhus University Hospital
RECRUITING
Denmark Copenhagen Rigshospitalet
RECRUITING
Denmark Herning Regionshospitalet Godstrup
RECRUITING
Denmark Odense C Odense Universitetshospital
RECRUITING
Denmark Vejle Vejle Sygehus
RECRUITING
France AMIENS cedex 1 CHU Amiens - Hopital Sud
RECRUITING
France Caen cedex 9 Hôpital Côte de Nacre
RECRUITING
France Grenoble CHU Grenoble
RECRUITING
France Le Mans Centre Hospitalier du Mans
RECRUITING
France Lille Hopital Saint Vincent de Paul
RECRUITING
France Montpellier CHU de Montpellier Hopital Saint Eloi
RECRUITING
France Nantes Cedex 1 CHU Nantes
RECRUITING
France Paris Hopital Saint-Antoine
RECRUITING
France Paris Hopital de la Pitie Salpetriere
RECRUITING
France Paris Hôpital Necker Enfants Malades
RECRUITING
France Toulouse Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
France Vandœuvre-lès-Nancy CHU de Nancy - Hopital de Brabois
RECRUITING
Germany Cottbus Medizinische Universitat Lausitz Carl Thiem
RECRUITING
Germany Dresden Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Germany Greifswald Universitätsmedizin Greifswald
RECRUITING
Germany Hamburg Asklepios Klinik Altona
RECRUITING
Germany Heidelberg Universitaetsklinikum Heidelberg
RECRUITING
Germany Marburg Universitaetsklinikum Giessen und Marburg GmbH
RECRUITING
Germany Tübingen Universitatsklinikum Tubingen
RECRUITING
Germany Ulm Universitatsklinikum Ulm
RECRUITING
Germany Zwickau Heinrich-Braun-Klinikum gGmbH
RECRUITING
Greece Athens Attica Alexandra General Hospital of Athens
RECRUITING
Greece Patra Agios Andreas General Hospital of Patra
RECRUITING
Greece Thessaloniki G Papanikolaou Hospital of Thessaloniki
RECRUITING
India Gurgaon Fortis Memorial Research Institute
RECRUITING
India Pune Deenanath Mangeshkar Hospital and Research Centre
RECRUITING
Israel Hadera Hillel Yaffe Medical Center
RECRUITING
Israel Haifa Bnai Zion Medical Center
RECRUITING
Israel Haifa Carmel Medical Center
RECRUITING
Israel Petah Tikva Rabin Medical Center
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Tel Aviv-Yafo Tel-Aviv Sourasky Medical Center
RECRUITING
Italy Bologna A O U Sant Orsola Malpighi
RECRUITING
Italy Milano Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Italy Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Italy Pisa Ospedale Santa Chiara AO Universitaria Pisana
RECRUITING
Italy Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Italy Roma Campus Bio Medico di Roma
RECRUITING
Italy Siena A O Universitaria Senese Ospedale Santa Maria alle Scotte
RECRUITING
Italy Turin A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
RECRUITING
Italy Udine ASUI Santa Maria della Misericordia di Udine
RECRUITING
Italy Varese Ospedale di Circolo e Fondazione Macchi
RECRUITING
Japan Bunkyo Ku Tokyo Medical and Dental University Hospital
RECRUITING
Japan Chiba Chiba Cancer Center
RECRUITING
Japan Gifu Ogaki Municipal Hospital
RECRUITING
Japan Gunma National Hospital Organization Shibukawa Medical Center
RECRUITING
Japan Hirakata Kansai Medical University Hospital
RECRUITING
Japan Hitachi Hitachi General Hospital
RECRUITING
Japan Iruma-gun Saitama Medical University Hospital
RECRUITING
Japan Kamogawa City Kameda Medical Center
RECRUITING
Japan Kashiwa National Cancer Center Hospital East
RECRUITING
Japan Kurashiki Kurashiki Central Hospital
RECRUITING
Japan Matsuyama Matsuyama Red Cross Hospital
RECRUITING
Japan Nagakute Aichi Medical University Hospital
RECRUITING
Japan Nagasaki-Shi JRC Nagasaki Genbaku Hospital
RECRUITING
Japan Niigata Niigata University Medical And Dental Hospital
RECRUITING
Japan Okayama National Hospital Organization Okayama Medical Center
RECRUITING
Japan Osaka Osaka Metropolitan University Hospital
RECRUITING
Japan Sapporo Hokkaido University Hospital
COMPLETED
Japan Tokyo Juntendo University Hospital
RECRUITING
Japan Tokyo The Cancer Institute Hospital of JFCR
RECRUITING
Japan Yamagata Yamagata University Hospital
RECRUITING
Japan Yamanashi Yamanashi Prefectural Central Hospital
RECRUITING
Malaysia Georgetown Hospital Pulau Pinang
RECRUITING
Malaysia Kota Kinabalu Hospital Queen Elizabeth
RECRUITING
Malaysia Kuala Lumpur University Malaya Medical Centre
RECRUITING
Malaysia Subang Jaya Subang Jaya Medical Centre
RECRUITING
Netherlands Amersfoort Meander Medisch Centrum
RECRUITING
Netherlands Amsterdam VUMC Amsterdam
RECRUITING
Netherlands Groningen Universitair Medisch Centrum Groningen
RECRUITING
Netherlands Utrecht UMC Utrecht
RECRUITING
Poland Gdansk Uniwersyteckie Centrum Kliniczne
RECRUITING
Poland Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Poland Lublin Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
RECRUITING
Portugal Almada Hosp. Garcia de Orta
RECRUITING
Portugal Braga Ccab - Hosp. de Braga
RECRUITING
Portugal Lisbon Champalimaud Foundation Champalimaud Centre
RECRUITING
Portugal Porto Instituto Portugues de Oncologia
RECRUITING
Portugal Vila Nova de Gaia Hospital de Vila Nova de Gaia E.P.E.
RECRUITING
Spain Badalona Hosp. Univ. Germans Trias I Pujol
RECRUITING
Spain Hospitalet de Llobregat Institut Catala d'Oncologia L'Hospitalet
RECRUITING
Spain Jerez de la Frontera Hosp. de Jerez de La Frontera
RECRUITING
Spain Leon Hosp. de Leon
RECRUITING
Spain Madrid Hosp. Univ. Infanta Leonor
RECRUITING
Spain Madrid Hosp. Univ. Ramon Y Cajal
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
Spain Murcia Hosp. Gral. Univ. J.M. Morales Meseguer
RECRUITING
Spain Oviedo Hospital Universitario Central de Asturias
RECRUITING
Spain Palma de Mallorca Hosp. Son Llatzer
RECRUITING
Spain Pontevedra Hosp. Montecelo
RECRUITING
Spain Pozuelo de Alarcon Hosp. Quiron Madrid Pozuelo
RECRUITING
Spain València Hospital Universitari i Politecnic La Fe
RECRUITING
Sweden Falun Falu Lasarett Medicinkliniken Falun
RECRUITING
Sweden Helsingborg Helsingborgs lasarett
RECRUITING
Sweden Uppsala Akademiska Sjukhuset
RECRUITING
Türkiye Ankara Ankara Gulhane Training and Research Hospital
RECRUITING
Türkiye Ankara Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Türkiye Ankara Ankara University Medical Faculty
RECRUITING
Türkiye Ankara Liv Hospital Ankara
RECRUITING
Türkiye Antalya Antalya Training And Research Hospital
RECRUITING
Türkiye Atakum Ondokuz Mayis University
RECRUITING
Türkiye Denizli Pamukkale University Medical Faculty
RECRUITING
Türkiye Istanbul Medipol University Hospital
RECRUITING
United Kingdom Aberdeen Aberdeen Royal Infirmary
RECRUITING
United Kingdom Birmingham University Hospitals Birmingham NHS Foundation Trust
RECRUITING
United Kingdom Colchester Colchester Hospital University NHS
RECRUITING
United Kingdom Liverpool The Clatterbridge Cancer Centre
RECRUITING
United Kingdom London Chelsea And Westminster Hospital
RECRUITING
United Kingdom London St George's Hospital
RECRUITING
United Kingdom Middlesborough James Cook University Hospital
RECRUITING
United Kingdom Norwich Norfolk and Norwich University Hospital
RECRUITING
United Kingdom Staffordshire Royal Stoke University Hospital
RECRUITING
United States Des Moines Mission Cancer Blood
RECRUITING
United States Bethesda Walter Reed National Military Medical Center
RECRUITING
Brazil Curitiba Liga Paranaense de Combate ao Cancer
RECRUITING
China Wuxi Wuxi People s Hospital
COMPLETED
Poland Katowice Pratia Onkologia Katowice
RECRUITING
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Geo Locations

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