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ACTIVE NOT RECRUITING
NCT05083169
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

587

Start Date

2021-10-14

Completion Date

2028-12-08

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Daratumumab

Daratumumab will be administered SC injection.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

DRUG

Dexamethasone

Dexamethasone will be administered orally or intravenously.

DRUG

Bortezomib

Bortezomib will be administered SC injection.

DRUG

Teclistamab

Teclistamab will be administered SC injection.

Locations (174)

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

Henry Ford Health System

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

Fred Hutchinson Cancer Center

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

Córdoba, Argentina

ZAS Cadix

Antwerp, Belgium

AZ St.-Jan Brugge-Oostende AV

Bruges, Belgium

UZ Gent

Ghent, 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

Brasília, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, 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

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Hospital Paulistano

São Paulo, Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, Brazil

Arthur J E Child Comprehensive 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

Créteil, France

Hopital Claude Huriez

Lille, France

CHU de Limoges Hopital Dupuytren

Limoges, France

Hospices Civils de Lyon HCL

Lyon, France

C.H.U. Hotel Dieu - France

Nantes, France

CHU De Poitiers

Poitiers, France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Pôle IUC Oncopole CHU

Toulouse, 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 im Breisgau, 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

Tübingen, 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

Florence, 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

Ōtake, Japan

Hokkaido University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

National Hospital Organization Sendai Medical Center

Sendai, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

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

Warsaw, Poland

Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

Wałbrzych, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia

Kyungpook National University Hospital

Daegu, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

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 Alarcón, 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

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Falu Lasarett

Falun, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Helsingborgs lasarett

Helsingborg, Sweden

Sunderby Sjukhus

Luleå, Sweden

Skanes universitetssjukhus

Lund, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Ondokuz Mayis University

Atakum, Turkey (Türkiye)

Medipol University Hospital

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

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