A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
NCT ID: NCT05552222
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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RECRUITING
PHASE3
1590 participants
INTERVENTIONAL
2022-10-25
2033-10-28
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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Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Teclistamab
Teclistamab will be administered as SC injection.
Daratumumab
Daratumumab will be administered as SC injection.
Lenalidomide
Lenalidomide will be administered orally.
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Daratumumab
Daratumumab will be administered as SC injection.
Lenalidomide
Lenalidomide will be administered orally.
Talquetamab
Talquetamab will be administered as SC injection.
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Daratumumab
Daratumumab will be administered as SC injection.
Lenalidomide
Lenalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Interventions
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Teclistamab
Teclistamab will be administered as SC injection.
Daratumumab
Daratumumab will be administered as SC injection.
Lenalidomide
Lenalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Talquetamab
Talquetamab will be administered as SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
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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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
UCSF Fresno
Clovis, California, United States
City of Hope Cancer Center
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of Connecticut
Farmington, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, United States
Cleveland Clinic Florida
Weston, Florida, United States
University Of Illinois Medical Center
Chicago, Illinois, United States
University of Iowa Health Care
Waukee, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, United States
Henry Ford Providence Novi Hospital
Novi, Michigan, United States
Henry Ford Providence Southfield CK Potluri Cancer Center
Southfield, Michigan, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
NYU Langone Hospital Long Island
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Durham VAMC
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
OhioHealth
Columbus, Ohio, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Oncology Associates Brock Cancer Center
Norfolk, Virginia, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, United States
Royal Prince Alfred Hospital
Camperdown, , Australia
Barwon Health - University Hospital Geelong
Geelong, , Australia
Liverpool Hospital
Liverpool, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Calvary Mater Newcastle Hospital
New South Wales, , Australia
Wollongong Hospital
Wollongong, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
SCRI CCCIT gem GmbH
Salzburg, , Austria
Medical University Vienna
Vienna, , Austria
Hanusch Krankenhaus
Vienna, , Austria
Institut Jules Bordet
Anderlecht, , Belgium
ZAS Cadix
Antwerp, , Belgium
Ghent University Hospital
Ghent, , Belgium
Jolimont
Haine Saint Paul La Louviere, , Belgium
Az Groeninge
Kortrijk, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, , Belgium
Fundacao Pio XII
Barretos, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Instituto Do Cancer Do Ceara
Fortaleza, , Brazil
Liga Norte Riograndense Contra O Cancer
Natal, , Brazil
Complexo Hospitalar de Niteroi
Niterói, , Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, , Brazil
Hospital Sao Rafael
Salvador, , Brazil
Hospital Nove de Julho
São Paulo, , Brazil
Clinica Medica Sao Germano S/S LTDA
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, Canada
Peking Union Medical College Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Tongren Hospital CMU
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Second Xiangya Hospital of Central South Hospital
Changsha, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
Beijing Chaoyang Hospital
Chaoyang District, , China
Sichuan Provincial Peoples Hospital
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Fujian Meidical University Union Hospital
Fuzhou, , China
Nanfang Hospital
Guangzhou, , China
Sun Yat -Sen University Cancer Center
Guangzhou, , China
No.1 Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, , China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, , China
Harbin medical university cancer hospital
Harbin, , China
Qilu Hospital of Shandong University
Jinan, , China
The First Affliated Hospital Of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Fourth People s Hospital
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Institute of Hematology and Blood Diseases Hospital
Tianjin, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Wuhan Tongji Hospital Tongji Medical College
Wuhan, , China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The first affiliated hospital of xiamen university
Xiamen, , China
Henan Cancer Hospital
Zhengzhou, , China
Fakultni nemocnice Brno
Brno - Bohunice, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Fakultni nemocnice Plzen
Pilsen, , Czechia
VFN v Praze
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Regionshospitalet Godstrup
Herning, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Vejle Sygehus
Vejle, , Denmark
CHU Henri Mondor
Créteil, , France
Hopital Claude Huriez
Lille, , France
CHU Nantes
Nantes, , France
CHU Hopital Saint Antoine
Paris, , France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
CHU Poitiers - Hopital la Miletrie
Poitiers, , France
CHU de Rennes - Hopital Pontchaillou
Rennes, , France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Helios Kliniken Berlin Buch Gmbh
Berlin, , Germany
Med. Universitatsklinik Essen
Essen, , Germany
Universitaetsklinikum Halle Saale
Halle, , Germany
Universitaetsklinik Hamburg-Eppendorf
Hamburg, , Germany
Klinikum Nuernberg Nord
Nuremberg, , Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Alexandra General Hospital of Athens
Athens Attica, , Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, , Greece
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, , Greece
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Rabin
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
ASST Papa Giovanni XXIII Bergamo
Bergamo, , Italy
A O U Sant Orsola Malpighi
Bologna, , Italy
Careggi University Hospital
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, , Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, , Italy
Universita Degli Studi di Roma Tor Vergata
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Juntendo University Hospital
Bunkyō City, , Japan
Chiba Cancer Center
Chiba, , Japan
Kameda Medical Center
Chiba, , Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Hyogo Medical University Hospital
Hyôgo, , Japan
Saitama Medical University Hospital
Iruma-gun, , Japan
Tokai University Hospital
Kanagawa, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Matsuyama Red Cross Hospital
Matsuyama, , Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, , Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, , Japan
Japanese Red Cross Medical Center
Shibuya-ku, , Japan
Shizuoka Cancer Center
Sunto Gun, , Japan
Fujita Health University Hospital
Toyoake, , Japan
Yamagata University Hospital
Yamagata, , Japan
Yamanashi Prefectural Central Hospital
Yamanashi, , Japan
VUMC Amsterdam
Amsterdam, , Netherlands
Gelre Ziekenhuis
Apeldoorn, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Zuyderland Medical Center
Sittard-Geleen, , Netherlands
Oslo University Hospital HF Ulleval sykehus
Oslo, , Norway
St. Olavs Hospital
Trondheim, , Norway
Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
Biała Podlaska, , Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, , Poland
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
Zielona Góra, , Poland
Uls Braga - Hosp. Braga
Braga, , Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon, , Portugal
Instituto Portugues de Oncologia
Porto, , Portugal
Uls Hosp Sao Joao
Porto, , Portugal
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Institut Catala d Oncologia L Hospitalet
Barcelona, , Spain
Hosp. Univ. Virgen de Las Nieves
Granada, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp Univ Hm Sanchinarro
Madrid, , Spain
Hosp. Univ. Son Espases
Palma de Mallorca, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Mutua Terrassa
Terrassa, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
Falu Lasarett
Falun, , Sweden
Skanes universitetssjukhus
Lund, , Sweden
Universitetssjukhuset Orebro
Örebro, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Inselspital Universitatsspital Bern
Bern, , Switzerland
Kantonsspital St Gallen
Sankt Gallen, , Switzerland
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, , Turkey (Türkiye)
Pamukkale University Medical Faculty
Denizli, , Turkey (Türkiye)
Medipol University Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
University Hospitals Bristol and Weston
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
University College London Hospitals
London, , United Kingdom
Imperial College Healthcare
London, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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64007957MMY3005
Identifier Type: OTHER
Identifier Source: secondary_id
2022-000909-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503442-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109237
Identifier Type: -
Identifier Source: org_study_id