Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT05083169
Conditions
Study Description
Brief Summary: 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).
Detailed Description: Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Birmingham, Birmingham, Alabama, United States
City of Hope, Duarte, California, United States
Stanford University Medical Center, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Tufts Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Ascension Providence Hospital, Southfield, Michigan, United States
Cleveland Clinic, Cleveland, Ohio, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Hospital Aleman, Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, , Argentina
Hospital Privado - Centro Medico de Cordoba, Cordoba, , Argentina
ZNA Cadix, Antwerpen, , Belgium
AZ St.-Jan Brugge-Oostende AV, Brugge, , Belgium
UZ Gent, Gent, , Belgium
Hopital de Jolimont, Haine-saint-paul, LA Louviere, , Belgium
Az Groeninge, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
Algemeen Ziekenhuis Delta, Roeselare, , Belgium
Hospitais Integradaos da Gavea S/A - DF Star, Brasilia, , Brazil
Liga Paranaense de Combate ao Cancer, Curitiba, , Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN, Florianopolis, , Brazil
Liga Norte Riograndense Contra O Cancer, Natal, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI), Rio de Janeiro, , Brazil
Hospital Sao Rafael, Salvador, , Brazil
Hospital Paulistano, Sao Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia, Sao Paulo, , Brazil
Clinica Sao Germano, Sao Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), São Paulo, , Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency - Vancouver BC, Vancouver, British Columbia, Canada
QEII Health Sciences, Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre University Health Network, Toronto, Ontario, Canada
Peking University First Hospital, Beijing, , China
Peking University People s Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun, , China
The Third Xiangya Hospital of Central Sourth University, Changshashi, , China
Beijing Chaoyang Hospital, Chaoyang District, , China
West China Hospital Sichuan University, Chengdu, , China
Fujian Meidical University Union Hospital, Fuzhou, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
First affiliated Hospital of Zhejiang University, Hangzhou, , China
Zhongda Hospital Southeast University, Nanjing, , China
First Affiliated Hospital of Guangxi Medical University, Nanning, , China
Shanghai Zhongshan Hospital, Shanghai, , China
Shengjing Hospital of China Medical University, Shenyang, , China
Peking University Shenzhen Hospital, Shenzhen, , China
Tianjin Medical University General Hospital, Tianjin, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Henan Cancer Hospital, Zhengzhou, , China
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus N, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Odense Universitets Hospital, Odense, , Denmark
Vejle Hospital, Vejle, , Denmark
CHU Henri Mondor, Creteil, , France
CHRU de Lille Hopital Claude Huriez, LILLE Cedex, , France
CHU de Limoges Hopital Dupuytren, Limoges, , France
C.H.U. Hotel Dieu - France, Nantes, , France
Centre hospitalier Lyon-Sud, Pierre Benite cedex, , France
CHU De Poitiers, Poitiers, , France
Institut de Cancerologie Strasbourg Europe ICANS, Strasbourg, , France
Pôle IUC Oncopole CHU, Toulouse cedex 9, , France
CHRU Hôpital Bretonneau, Tours, , France
Universitätsklinikum Carl-Gustav-Carus Dresden, Dresden, , Germany
Heinrich-Heine -Universitaet Duesseldorf, Düsseldorf, , Germany
Evang. Krankenhaus Essen-Mitte gGmbH, Essen, , Germany
Universitatsklinikum Freiburg, Freiburg, , Germany
Universitaetsklinikum Hamburg Eppendorf, Hamburg, , Germany
St. Barbara-Klinik Hamm GmbH, Hamm, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Tuebingen, Tubingen, , Germany
Alexandra General Hospital of Athens, Athens Attica, , Greece
Anticancer Hospital of Thessaloniki Theageneio, Thessaloniki, , Greece
G.Papanikolaou, Thessaloniki, , Greece
U.O. Ematologia con Trapianto- AOU Policlinico di Bari, Bari, , Italy
ASST Papa Giovanni XXIII - Bergamo, Bergamo, , Italy
Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi, Pavia, , Italy
Università di Roma 'La Sapienza' - Ospedale Umberto 1°, Roma, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin, , Italy
Fukuoka University Hospital, Fukuoka, , Japan
Ogaki Municipal Hospital, Gifu, , Japan
National Hospital Organization Mito Medical Center, Higashiibaraki-gun, , Japan
Tokai University Hospital, Isehara, , Japan
Shonan Kamakura General Hospital, Kamakura-shi, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Dokkyo Medical University Saitama Medical Center, Koshigaya, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kurume University Hospital, Kurume, , Japan
National Hospital Organization Matsumoto Medical Center, Matsumoto, , Japan
Nagoya City University Hospital, Nagoya, , Japan
Hyogo Medical University Hospital, Nishinomiya-shi, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
National Hospital Organization Hiroshima-Nishi Medical Center, Otake, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
National Hospital Organization Sendai Medical Center, Sendai-City, , Japan
Tohoku University Hospital, Sendai, , Japan
Japanese Red Cross Medical Center, Shibuya-ku, , Japan
Iwate Medical University Hospital, Shiwa-gun, , Japan
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
VU Medisch Centrum, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Sint Antonius Ziekenhuis - Afd.Interne - INT, Nieuwegein, , Netherlands
Radboudumc, Nijmegen, , Netherlands
Isala Kliniek, Zwolle, , Netherlands
Klinika Hematologii i Transplantologii, UCK, Gdansk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce, , Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Lublin, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu, Wałbrzych, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw, , Poland
S.P. Botkin Moscow City Clinical Hospital, Moscow, , Russian Federation
Clinical Research Institute of Hematology and Transfusiology, St-Petersburg, , Russian Federation
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. de Cabuenes, Gijón, , Spain
Hosp. Univ. de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria, , Spain
Hosp. Gral. Univ. Gregorio Maranon, Madrid, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. Son Espases, Palma, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcon, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla, Santander, , Spain
Hosp. Clinico Univ. de Santiago, Santiago de Compostela, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Univ. I Politecni La Fe, Valencia, , Spain
Falu Lasarett, Falun, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Helsingborgs lasarett, Helsingborg, , Sweden
Sunderby Sjukhus, Luleå, , Sweden
Skanes universitetssjukhus, Lund, , Sweden
Norrlands Universitetssjukhus, Umea, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Ankara University Medical Faculty, Ankara, , Turkey
Ondokuz Mayis University, Atakum, , Turkey
Medipol University Hospital, Istanbul, , Turkey
Dokuz Eylul University Medical Faculty, Izmir, , Turkey
Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, , United Kingdom
Ninewells Hospital & Medical School, Dundee, , United Kingdom
Kings College Hospital, London, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust, Plymouth, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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