Spots Global Cancer Trial Database for A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Official Title: 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
Study ID: NCT05572515
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
MemorialCare Long Beach Medical Center, Long Beach, California, United States
University of California Irvine, Orange, California, United States
PIH Health Hospital, Whittier, California, United States
University of Connecticut, Farmington, Connecticut, United States
University of Miami Sylvester Cancer Center, Miami, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
East Jefferson General Hospital Bone Marrow Transport Clinic, Metairie, Louisiana, United States
Boston University Medical Center, Boston, Massachusetts, United States
Saint Luke's Hospital - Saint Luke's Cancer Specialists, Chesterfield, Missouri, United States
Cooper Health System MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York, United States
Durham VAMC, Durham, North Carolina, United States
Penn Medicine Lancaster General Health, Lancaster, Pennsylvania, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Blacktown Hospital, Blacktown, , Australia
St. Vincent's Hospital Melbourne, Fitzroy, , Australia
Box Hill Hospital, Melbourne, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Sir Charles Gairdner Hospital, Nedlands, , Australia
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, , Austria
Medical University Vienna MUV, Vienna, , Austria
Algemeen Ziekenhuis Klina, Brasschaat, , Belgium
Jolimont, Haine-St-Paul, , Belgium
Az Groeninge, Kortrijk, , Belgium
Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium
CHR de la Citadelle, Liege, , Belgium
Hospitais Integradaos da Gavea S/A - DF Star, Brasilia, , Brazil
Fundacao Universidade de Caxias do Sul, Caxias do Sul, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia, Joinville, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Complexo Hospitalar de Niteroi, Niteroi, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base, Sao Jose do Rio Preto, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, Sao Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center, Sao Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Sao Paulo, , Brazil
Real e Benemérita Associação Portuguesa de Beneficência, São Paulo, , Brazil
Hospital Alemao Oswaldo Cruz, São Paulo, , Brazil
Clinica Sao Germano, São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo, , Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Brampton Civic Hospital, Brampton, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Beijing Chaoyang Hospital, Beijing, , China
BeiJing JiShuiTan Hospital, Beijing, , China
The First Bethune Hospital of Jilin University, Changchun, , China
The Third Xiangya Hospital, Central South University, Changsha, , China
Sichuan Provincial Peoples Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
Fujian Meidical University Union Hospital, Fu Zhou, , China
Sun Yat -Sen University Cancer Center, Guangzhou, , China
First affiliated Hospital of Zhejiang University, Hangzhou, , China
Harbin medical university cancer hospital, Harbin, , China
The First Affiliated Hospital of NanChang University, Nanchang, , China
Nanjing Drum Tower Hospital, Nanjing, , China
First Affiliated Hospital of Guangxi Medical University, Nanning, , China
Shanghai Fourth People s Hospital, Shanghai, , China
Shengjing Hospital of China Medical University, Shenyang, , China
Shenzhen 2nd People's Hospital, Shenzhen, , China
Institute of Hematology and Blood Diseases Hospital, Tian Jin, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Wuhan Union Hospital, Wuhan, , China
Wuxi People s Hospital, Wuxi, , China
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
Henan Cancer Hospital, Zhengzhou, , China
Fakultni nemocnice Brno, Brno, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Regionshospitalet Godstrup, Herning, , Denmark
Odense Universitetshospital, Odense C, , Denmark
Vejle Sygehus, Vejle, , Denmark
CHU Amiens - Hopital Sud, AMIENS cedex 1, , France
Hôpital Côte de Nacre, Caen cedex 9, , France
CHU Grenoble, Grenoble, , France
Centre Hospitalier du Mans, Le Mans, , France
Hopital Saint Vincent de Paul, Lille, , France
CHU de Montpellier, Hopital Saint-Eloi, Montpellier, , France
CHU Nantes, Nantes Cedex 1, , France
Hopital Saint-Antoine, Paris, , France
Hopital de la Pitie Salpetriere, Paris, , France
Hôpital Necker Enfants Malades, Paris, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, , France
CHU de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy, , France
Carl-Thiem-Klinikum Cottbus gGmbH, Cottbus, , Germany
Universitatsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsmedizin Greifswald, Greifswald, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Giessen und Marburg GmbH, Marburg, , Germany
Universitatsklinikum Tubingen, Tübingen, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Heinrich-Braun-Klinikum gGmbH, Zwickau, , Germany
Alexandra General Hospital of Athens, Athens Attica, , Greece
Agios Andreas General Hospital of Patra, Patra, , Greece
G Papanikolaou Hospital of Thessaloniki, Thessaloniki, , Greece
Fortis Memorial Research Institute, Gurgaon, , India
Deenanath Mangeshkar Hospital and Research Centre, Pune, , India
Hillel Yaffe Medical Center, Hadera, , Israel
Bnai Zion Medical Center, Haifa, , Israel
Carmel Medical Center, Haifa, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv-Yafo, , Israel
A O U Sant Orsola Malpighi, Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Ospedale Santa Chiara AO Universitaria Pisana, Pisa, , Italy
Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, , Italy
Campus Bio Medico di Roma, Roma, , Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte, Siena, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin, , Italy
ASUI Santa Maria della Misericordia di Udine, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Chiba Cancer Center, Chiba, , Japan
Ogaki Municipal Hospital, Gifu, , Japan
National Hospital Organization Shibukawa Medical Center, Gunma, , Japan
Kansai Medical University Hospital, Hirakata, , Japan
Hitachi General Hospital, Hitachi, , Japan
Saitama Medical University Hospital, Iruma-gun, , Japan
Kameda General Hospital, Kamogawa City, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Kurashiki Central Hospital, Kurashiki, , Japan
Matsuyama Red Cross Hospital, Matsuyama, , Japan
Aichi Medical University Hospital, Nagakute, , Japan
JRC Nagasaki Genbaku Hospital, Nagasaki-Shi, , Japan
Niigata University Medical And Dental Hospital, Niigata, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Hokkaido University Hospital, Sapporo, , Japan
Juntendo University Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Yamanashi Prefectural Central Hospital, Yamanashi, , Japan
Hospital Pulau Pinang, Georgetown, , Malaysia
Hospital Queen Elizabeth, Kota Kinabalu, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Subang Jaya Medical Centre, Subang Jaya, , Malaysia
Meander Medisch Centrum, Amersfoort, , Netherlands
VUMC Amsterdam, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce, , Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie, Lublin, , Poland
Hosp. Garcia de Orta, Almada, , Portugal
Ccab - Hosp. de Braga, Braga, , Portugal
Champalimaud Foundation Champalimaud Centre, Lisbon, , Portugal
Instituto Portugues de Oncologia, Porto, , Portugal
Hospital de Vila Nova de Gaia E.P.E., Vila Nova de Gaia, , Portugal
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Institut Catala d'Oncologia L'Hospitalet, Hospitalet de Llobregat, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Hosp. de Leon, Leon, , Spain
Hosp. Univ. Infanta Leonor, Madrid, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Gral. Univ. J.M. Morales Meseguer, Murcia, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hosp. Son Llatzer, Palma de Mallorca, , Spain
Hosp. Montecelo, Pontevedra, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcon, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Falu Lasarett Medicinkliniken Falun, Falun, , Sweden
Helsingborgs lasarett, Helsingborg, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Ankara Gulhane Training and Research Hospital, Ankara, , Turkey
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, , Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Liv Hospital Ankara, Ankara, , Turkey
Antalya Training And Research Hospital, Antalya, , Turkey
Ondokuz Mayis University, Atakum, , Turkey
Pamukkale University Medical Faculty, Denizli, , Turkey
Medipol University Hospital, Istanbul, , Turkey
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Colchester Hospital University NHS, Colchester, , United Kingdom
The Clatterbridge Cancer Centre, Liverpool, , United Kingdom
Chelsea And Westminster Hospital, London, , United Kingdom
St George's Hospital, London, , United Kingdom
James Cook University Hospital, Middlesborough, , United Kingdom
Norfolk and Norwich University Hospital, Norwich, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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