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
NCT ID: NCT05083169
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
587 participants
INTERVENTIONAL
2021-10-14
2028-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Teclistamab-daratumumab (Tec-Dara)
Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
Daratumumab
Daratumumab will be administered SC injection.
Teclistamab
Teclistamab will be administered SC injection.
Arm B: DPd or DVd
Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.
Daratumumab
Daratumumab will be administered SC injection.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Bortezomib
Bortezomib will be administered SC injection.
Interventions
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Daratumumab
Daratumumab will be administered SC injection.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Bortezomib
Bortezomib will be administered SC injection.
Teclistamab
Teclistamab will be administered SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion
* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment
* Have clinical laboratory values within the specified range
Exclusion Criteria
2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization
* Received any prior B cell maturation antigen (BCMA)-directed therapy
* Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG
* Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization
* Received a live, attenuated vaccine within 4 weeks before randomization
* Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
CHRU de Lille Hopital Claude Huriez
Lille, , France
CHU de Limoges Hopital Dupuytren
Limoges, , France
C.H.U. Hotel Dieu - France
Nantes, , France
Centre hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU De Poitiers
Poitiers, , France
Institut de Cancerologie Strasbourg Europe ICANS
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
Countries
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Other Identifiers
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64007957MMY3001
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004742-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503441-55-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109049
Identifier Type: -
Identifier Source: org_study_id