RecruitingPhase 3NCT05552222

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

1,590 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying two new combination immunotherapy regimens — teclistamab plus daratumumab and lenalidomide, or talquetamab plus daratumumab and lenalidomide — in patients with newly diagnosed multiple myeloma who are not good candidates for a stem cell transplant. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You are not a good candidate for high-dose chemotherapy with stem cell transplant (due to age, other health conditions, or personal choice to defer) - Your daily functioning is good to moderate (ECOG 0–2) - You agree not to become pregnant or father a child during and for a period after the study **You may NOT be eligible if...** - You have received any prior treatment for multiple myeloma (other than a short course of steroids) - You have had plasmapheresis within the past 28 days - You have had a stroke, TIA, or seizure within the past 6 months - You have known allergies to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeclistamab

Teclistamab will be administered as SC injection.

DRUGDaratumumab

Daratumumab will be administered as SC injection.

DRUGLenalidomide

Lenalidomide will be administered orally.

DRUGDexamethasone

Dexamethasone will be administered either orally or intravenously (IV).

DRUGTalquetamab

Talquetamab will be administered as SC injection.

Locations(263)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

UCSF Fresno

Clovis, California, United States

City of Hope Duarte

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

Valkyrie Clinical Trials

Los Angeles, 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

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

City of Hope Cancer Center

Newnan, Georgia, 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

Weill Cornell Medical College

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Novant Health

Charlotte, North Carolina, United States

Durham VAMC

Durham, North Carolina, United States

Novant Health Zimmer Cancer Institute

Wilmington, North Carolina, United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, 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

The Ohio State University- James Cancer Hospital

Columbus, Ohio, United States

OhioHealth

Columbus, Ohio, United States

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, United States

Virginia Oncology Associates Brock Cancer Center

Norfolk, Virginia, United States

Richmond VA Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University Medical Center

Richmond, 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

ZAS Augustinus

Antwerp, Belgium

Ghent University Hospital

Ghent, Belgium

Jolimont

Haine Saint Paul La Louviere, Belgium

Az Groeninge

Kortrijk, Belgium

Universitair Ziekenhuis Leuven

Leuven, 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

Hospices Civils de Lyon HCL

Lyon, France

CHU Nantes

Nantes, France

CHU Hopital Saint Antoine

Paris, France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, France

CHU Poitiers - Hopital la Miletrie

Poitiers, France

CHU de Rennes - Hopital Pontchaillou

Rennes, France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

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

Theageneio Cancer Hospital

Thessaloniki, Greece

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, Greece

Soroka Medical Center

Beersheba, Israel

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

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, Poland

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Uniwersyteckie Centrum Kliniczne

Warsaw, Poland

Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze

Zielona Góra, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Champalimaud Foundation Champalimaud Centre

Lisbon, Portugal

Uls Hosp Sao Joao

Porto, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

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 Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

Ankara, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, Turkey (Türkiye)

Pamukkale University Medical Faculty

Denizli, Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

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

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