A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
Status: Recruiting
Location: See all (229) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic 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
Locations
United States
California
UCSF Fresno
RECRUITING
Clovis
City of Hope Cancer Center
RECRUITING
Duarte
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
Connecticut
University of Connecticut
RECRUITING
Farmington
Yale New Haven Hospital
RECRUITING
New Haven
Delaware
ChristianaCare Helen F Graham Cancer Center and Research Institute
RECRUITING
Newark
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Iowa
University of Iowa Health Care
RECRUITING
Waukee
Illinois
University Of Illinois Medical Center
RECRUITING
Chicago
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Louisiana
LSUHSC Shreveport Feist-Weiller Cancer Center
RECRUITING
Shreveport
Maryland
Johns Hopkins University School of Medicine JHUSOM
RECRUITING
Baltimore
Michigan
Cancer And Hematology Centers of Western Michigan PC
RECRUITING
Grand Rapids
North Carolina
Durham VAMC
RECRUITING
Durham
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Nebraska
Nebraska Cancer Specialists
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New Mexico
Christus St. Vincent Regional Cancer Center
RECRUITING
Santa Fe
New York
Hematology-Oncology Associates of CNY
RECRUITING
East Syracuse
Northwell Health Cancer Institute
RECRUITING
Lake Success
NYU Langone Hospital Long Island
RECRUITING
Mineola
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Cleveland Clinic Main Campus
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
OhioHealth
RECRUITING
Columbus
Pennsylvania
Allegheny Health Network
RECRUITING
Pittsburgh
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Joe Arrington Cancer Research Treatment Center
RECRUITING
Lubbock
Utah
Utah Cancer Specialists
RECRUITING
Salt Lake City
Washington
NorthWest Medical Specialties, PLLC
RECRUITING
Tacoma
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Barwon Health - University Hospital Geelong
RECRUITING
Geelong
Liverpool Hospital
RECRUITING
Liverpool
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Calvary Mater Newcastle Hospital
RECRUITING
New South Wales
Wollongong Hospital
RECRUITING
Wollongong
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
SCRI CCCIT gem GmbH
RECRUITING
Salzburg
Hanusch Krankenhaus
RECRUITING
Vienna
Medical University Vienna
RECRUITING
Vienna
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
ZAS Cadix
RECRUITING
Antwerp
Ghent University Hospital
RECRUITING
Ghent
Jolimont
COMPLETED
Haine Saint Paul La Louviere
Az Groeninge
RECRUITING
Kortrijk
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
GZA Ziekenhuizen- Campus St Augustinus
COMPLETED
Wilrijk
Brazil
Fundacao Pio XII
RECRUITING
Barretos
Santa Casa de Misericordia de Belo Horizonte
RECRUITING
Belo Horizonte
Liga Paranaense de Combate ao Cancer
RECRUITING
Curitiba
Instituto Do Cancer Do Ceara
RECRUITING
Fortaleza
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Hospital De Clinicas De Porto Alegre
RECRUITING
Porto Alegre
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
RECRUITING
Ribeirão Preto
Hospital Sao Rafael
RECRUITING
Salvador
Clinica Medica Sao Germano S/S LTDA
RECRUITING
São Paulo
Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
São Paulo
Hospital Nove de Julho
RECRUITING
São Paulo
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
Cross Cancer Institute
COMPLETED
Edmonton
CHU de Quebec L Hotel Dieu de Quebec
RECRUITING
Québec
British Columbia Cancer Agency
RECRUITING
Vancouver
China
Beijing Tongren Hospital CMU
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
The Second Xiangya Hospital of Central South Hospital
RECRUITING
Changsha
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
Beijing Chaoyang Hospital
RECRUITING
Chaoyang District
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Meidical University Union Hospital
RECRUITING
Fuzhou
Nanfang Hospital
RECRUITING
Guangzhou
Sun Yat -Sen University Cancer Center
RECRUITING
Guangzhou
No.1 Affiliated Hospital, Medical College of Zhejiang University
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Harbin medical university cancer hospital
COMPLETED
Harbin
Qilu Hospital of Shandong University
COMPLETED
Jinan
The First Affliated Hospital Of Nanchang University
RECRUITING
Nanchang
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiao Tong University
RECRUITING
Shanghai
Shanghai Fourth People s Hospital
RECRUITING
Shanghai
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
Institute of Hematology and Blood Diseases Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Wuhan Tongji Hospital Tongji Medical College
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The first affiliated hospital of xiamen university
RECRUITING
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Regionshospitalet Godstrup
RECRUITING
Herning
Zealand University Hospital
RECRUITING
Roskilde
Vejle Sygehus
RECRUITING
Vejle
France
CHU Henri Mondor
RECRUITING
Créteil
Hopital Claude Huriez
RECRUITING
Lille
CHU Nantes
RECRUITING
Nantes
CHU Hopital Saint Antoine
RECRUITING
Paris
CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
Pessac
CHU Lyon Sud
RECRUITING
Pierre-bénite
CHU Poitiers - Hopital la Miletrie
RECRUITING
Poitiers
CHU de Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Institut de Cancerologie Strasbourg Europe ICANS
RECRUITING
Strasbourg
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
Germany
Helios Kliniken Berlin Buch Gmbh
RECRUITING
Berlin
Med. Universitatsklinik Essen
RECRUITING
Essen
Universitaetsklinikum Halle Saale
RECRUITING
Halle
Universitaetsklinik Hamburg-Eppendorf
RECRUITING
Hamburg
Klinikum Nuernberg Nord
RECRUITING
Nuremberg
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
RECRUITING
Tübingen
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens Attica
Anticancer Hospital of Thessaloniki Theageneio
RECRUITING
Thessaloniki
G Papanikolaou Hospital of Thessaloniki
RECRUITING
Thessalonikis
Israel
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
ASST Papa Giovanni XXIII Bergamo
RECRUITING
Bergamo
A O U Sant Orsola Malpighi
RECRUITING
Bologna
Careggi University Hospital
RECRUITING
Florence
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
RECRUITING
Naples
IRCCS Policlinico San Matteo, Università degli studi di Pavi
RECRUITING
Pavia
Universita Degli Studi di Roma Tor Vergata
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
RECRUITING
Torino
Japan
Juntendo University Hospital
RECRUITING
Bunkyō City
Chiba Cancer Center
RECRUITING
Chiba
Kameda Medical Center
RECRUITING
Chiba
National Hospital Organization Mito Medical Center
RECRUITING
Higashiibaraki-gun
Kansai Medical University Hospital
RECRUITING
Hirakata
Hyogo Medical University Hospital
RECRUITING
Hyôgo
Saitama Medical University Hospital
RECRUITING
Iruma-gun
Tokai University Hospital
RECRUITING
Kanagawa
Kanazawa University Hospital
RECRUITING
Kanazawa
Kumamoto University Hospital
RECRUITING
Kumamoto
Matsuyama Red Cross Hospital
RECRUITING
Matsuyama
National Hospital Organization Nagasaki Medical Center
RECRUITING
Nagasaki
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
National Hospital Organization Shibukawa Medical Center
RECRUITING
Shibukawa
Japanese Red Cross Medical Center
RECRUITING
Shibuya-ku
Shizuoka Cancer Center
RECRUITING
Sunto Gun
Fujita Health University Hospital
RECRUITING
Toyoake
Yamagata University Hospital
RECRUITING
Yamagata
Yamanashi Prefectural Central Hospital
RECRUITING
Yamanashi
Netherlands
VUMC Amsterdam
RECRUITING
Amsterdam
Gelre Ziekenhuis
RECRUITING
Apeldoorn
Reinier de Graaf Gasthuis
RECRUITING
Delft
St. Antonius Ziekenhuis Nieuwegein
RECRUITING
Nieuwegein
Zuyderland Medical Center
RECRUITING
Sittard-geleen
Norway
Oslo University Hospital HF Ulleval sykehus
RECRUITING
Oslo
St. Olavs Hospital
RECRUITING
Trondheim
Poland
Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
COMPLETED
Biała Podlaska
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
RECRUITING
Brzozów
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
RECRUITING
Bydgoszcz
Pratia Onkologia Katowice
RECRUITING
Katowice
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Lodz
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
RECRUITING
Lublin
Samodzielny Publiczny Szpital Kliniczny Nr 1
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
COMPLETED
Zielona Góra
Portugal
Uls Braga - Hosp. Braga
RECRUITING
Braga
Champalimaud Foundation Champalimaud Centre
RECRUITING
Lisbon
Instituto Portugues de Oncologia
RECRUITING
Porto
Uls Hosp Sao Joao
RECRUITING
Porto
Republic of Korea
Dong-A University Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
RECRUITING
Seoul
Spain
Hosp. Univ. Germans Trias I Pujol
RECRUITING
Badalona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Institut Catala d Oncologia L Hospitalet
RECRUITING
Barcelona
Hosp. Univ. Virgen de Las Nieves
RECRUITING
Granada
Hosp. de Jerez de La Frontera
RECRUITING
Jerez De La Frontera
Hosp Univ Hm Sanchinarro
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. La Paz
RECRUITING
Madrid
Hosp. Univ. Son Espases
RECRUITING
Palma De Mallorca
Hosp. Quiron Madrid Pozuelo
RECRUITING
Pozuelo De Alarcón
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
Hosp. Mutua Terrassa
RECRUITING
Terrassa
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Sweden
Falu Lasarett
RECRUITING
Falun
Skanes universitetssjukhus
RECRUITING
Lund
Universitetssjukhuset Orebro
RECRUITING
Örebro
Karolinska University Hospital Huddinge
RECRUITING
Stockholm
Switzerland
Inselspital Universitatsspital Bern
RECRUITING
Bern
Kantonsspital St Gallen
RECRUITING
Sankt Gallen
Turkey
Ankara University Medical Faculty
RECRUITING
Ankara
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Memorial Antalya Hospital
RECRUITING
Antalya
Pamukkale University Medical Faculty
COMPLETED
Denizli
Medipol University Hospital
RECRUITING
Istanbul
Dokuz Eylul University Medical Faculty
COMPLETED
Izmir
Ondokuz Mayis University
RECRUITING
Samsun
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Blackpool Victoria Hospital
RECRUITING
Blackpool
University Hospitals Bristol and Weston
RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
Kent and Canterbury Hospital
RECRUITING
Canterbury
Western General Hospital
RECRUITING
Edinburgh
Imperial College Healthcare
RECRUITING
London
University College London Hospitals
RECRUITING
London
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-10-25
Estimated Completion Date: 2033-10-28
Participants
Target number of participants: 1590
Treatments
Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Active_comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC