Back to Trials
NCT05552222PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

10/25/2022

Completion Date

10/28/2033

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization * 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

Interventions

DRUG

Teclistamab

DRUG

Daratumumab

DRUG

Lenalidomide

DRUG

Dexamethasone

DRUG

Talquetamab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Multiple Myeloma

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

University of Arizona Cancer Center

Tucson, Arizona 85719

United States

UCSF Fresno

Clovis, California 93611

United States

City of Hope Duarte

Duarte, California 91010

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

University of Connecticut

Farmington, Connecticut 06030

United States

Yale New Haven Hospital

New Haven, Connecticut 06510

United States

ChristianaCare Helen F Graham Cancer Center and Research Institute

Newark, Delaware 19713

United States

Memorial Healthcare System

Hollywood, Florida 33021

United States

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida 32804

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

City of Hope Cancer Center

Newnan, Georgia 30265

United States

University Of Illinois Medical Center

Chicago, Illinois 60612

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

University of Iowa Health Care

Waukee, Iowa 50263

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

LSUHSC Shreveport Feist-Weiller Cancer Center

Shreveport, Louisiana 71103

United States

Johns Hopkins University School of Medicine JHUSOM

Baltimore, Maryland 21231

United States

Center for Cancer and Blood Disorders

Bethesda, Maryland 20817

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion

Detroit, Michigan 48202

United States

Cancer And Hematology Centers of Western Michigan PC

Grand Rapids, Michigan 49503

United States

Henry Ford Providence Novi Hospital

Novi, Michigan 48374

United States

Henry Ford Providence Southfield CK Potluri Cancer Center

Southfield, Michigan 48075

United States

MidAmerica Cancer Care

Kansas City, Missouri 64132

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Astera Cancer Care

East Brunswick, New Jersey 08816

United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico 87505

United States

Hematology-Oncology Associates of CNY

East Syracuse, New York 13057

United States

Northwell Health Cancer Institute

Lake Success, New York 11042

United States

NYU Langone Hospital Long Island

Mineola, New York 11500

United States

Perlmutter Cancer Center at NYU Langone Health

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Weill Cornell Medical College

New York, New York 10065

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Novant Health

Charlotte, North Carolina 28204

United States

Durham VAMC

Durham, North Carolina 27705

United States

Novant Health Zimmer Cancer Institute

Wilmington, North Carolina 28401

United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

The Christ Hospital Cancer Center

Cincinnati, Ohio 45219

United States

Oncology Hematology Care

Cincinnati, Ohio 45236

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States

The Ohio State University- James Cancer Hospital

Columbus, Ohio 43210

United States

OhioHealth

Columbus, Ohio 43214

United States

Penn State Milton S Hershey Medical Ctr

Hershey, Pennsylvania 17033

United States

Allegheny Health Network

Pittsburgh, Pennsylvania 15224

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

MUSC-Hollings Cancer Center

Charleston, South Carolina 29425

United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee 37232

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75235

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas 79410

United States

Utah Cancer Specialists

Salt Lake City, Utah 84106

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia 22060

United States

Virginia Oncology Associates Brock Cancer Center

Norfolk, Virginia 23502

United States

Richmond VA Medical Center

Richmond, Virginia 23249

United States

Virginia Commonwealth University Medical Center

Richmond, Virginia 23298

United States

NorthWest Medical Specialties, PLLC

Tacoma, Washington 98405

United States

Royal Prince Alfred Hospital

Camperdown, 2050

Australia

Barwon Health - University Hospital Geelong

Geelong, 3220

Australia

Liverpool Hospital

Liverpool, 2170

Australia

Sir Charles Gairdner Hospital

Nedlands, 6009

Australia

Calvary Mater Newcastle Hospital

New South Wales, 2298

Australia

Wollongong Hospital

Wollongong, 2500

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020

Austria

SCRI CCCIT gem GmbH

Salzburg, 5020

Austria

Medical University Vienna

Vienna, 1090

Austria

Hanusch Krankenhaus

Vienna, 1140

Austria

Institut Jules Bordet

Anderlecht, 1070

Belgium

ZAS Cadix

Antwerp, 2030

Belgium

ZAS Augustinus

Antwerp, 2610

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Jolimont

Haine Saint Paul La Louviere, 7100

Belgium

Az Groeninge

Kortrijk, 8500

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Fundacao Pio XII

Barretos, 14784 400

Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150 320

Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, 81520 060

Brazil

Instituto Do Cancer Do Ceara

Fortaleza, 60430-230

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062-000

Brazil

Complexo Hospitalar de Niteroi

Niterói, 24030-103

Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035 903

Brazil

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14051-140

Brazil

Hospital Sao Rafael

Salvador, 41235-190

Brazil

Hospital Nove de Julho

São Paulo, 01409-902

Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, 04537-081

Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403 000

Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

British Columbia Cancer Agency

Vancouver, British Columbia V5Z4E6

Canada

Lakeridge Health Oshawa

Oshawa, Ontario L1G-2B9

Canada

CHU de Quebec L Hotel Dieu de Quebec

Québec, Quebec G1J 1Z4

Canada

Peking Union Medical College Hospital

Beijing, 100006

China

Peking University First Hospital

Beijing, 100034

China

Beijing Tongren Hospital CMU

Beijing, 100051

China

The First Hospital of Jilin University

Changchun, 130061

China

The Second Xiangya Hospital of Central South Hospital

Changsha, 410011

China

Changzhou No 2 Peoples Hospital

Changzhou, 213004

China

Beijing Chaoyang Hospital

Chaoyang District, 100020

China

Sichuan Provincial Peoples Hospital

Chengdu, 610072

China

Chongqing University Cancer Hospital

Chongqing, 400030

China

Fujian Meidical University Union Hospital

Fuzhou, 350001

China

Nanfang Hospital

Guangzhou, 510515

China

Sun Yat -Sen University Cancer Center

Guangzhou, 511363

China

No.1 Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, 310003

China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310003

China

Harbin medical university cancer hospital

Harbin, 150081

China

Qilu Hospital of Shandong University

Jinan, 250012

China

The First Affliated Hospital Of Nanchang University

Nanchang, 330006

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

Zhongda Hospital Southeast University

Nanjing, 214135

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, 530021

China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025

China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200127

China

Shanghai Fourth People s Hospital

Shanghai, 200434

China

Shengjing Hospital Of China Medical University

Shenyang, 110022

China

Peking University Shenzhen Hospital

Shenzhen, 518036

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060

China

Institute of Hematology and Blood Diseases Hospital

Tianjin, 301609

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Wuhan Tongji Hospital Tongji Medical College

Wuhan, 430032

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004

China

The first affiliated hospital of xiamen university

Xiamen, 361003

China

Henan Cancer Hospital

Zhengzhou, 450008

China

Fakultni nemocnice Brno

Brno-Bohunice, 625 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00

Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 52

Czechia

Fakultni nemocnice Plzen

Pilsen, 304 60

Czechia

VFN v Praze

Prague, 128 08

Czechia

Aalborg University Hospital

Aalborg, 9000

Denmark

Regionshospitalet Godstrup

Herning, 7400

Denmark

Zealand University Hospital

Roskilde,

Denmark

Vejle Sygehus

Vejle, 7100

Denmark

CHU Henri Mondor

Créteil, 94010

France

Hopital Claude Huriez

Lille, 59000

France

Hospices Civils de Lyon HCL

Lyon, 69002

France

CHU Nantes

Nantes, 44093

France

CHU Hopital Saint Antoine

Paris, 75571

France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33604

France

CHU Poitiers - Hopital la Miletrie

Poitiers, 86021

France

CHU de Rennes - Hopital Pontchaillou

Rennes, 35033

France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200

France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059

France

Helios Kliniken Berlin Buch Gmbh

Berlin, 13125

Germany

Med. Universitatsklinik Essen

Essen, 45147

Germany

Universitaetsklinikum Halle Saale

Halle, 06120

Germany

Universitaetsklinik Hamburg-Eppendorf

Hamburg, 20251

Germany

Klinikum Nuernberg Nord

Nuremberg, 90419

Germany

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, 72076

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97080

Germany

Alexandra General Hospital of Athens

Athens Attica, 115 28

Greece

Theageneio Cancer Hospital

Thessaloniki, 546 39

Greece

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, 570 10

Greece

Soroka Medical Center

Beersheba, 8457108

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Rabin

Petah Tikva, 49100

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127

Italy

A O U Sant Orsola Malpighi

Bologna, 40138

Italy

Careggi University Hospital

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

Naples, 80131

Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100

Italy

Universita Degli Studi di Roma Tor Vergata

Roma, 00133

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Juntendo University Hospital

Bunkyō City, 113 8431

Japan

Chiba Cancer Center

Chiba, 260 0801

Japan

Kameda Medical Center

Chiba, 296-0041

Japan

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, 311-3193

Japan

Kansai Medical University Hospital

Hirakata, 573 1191

Japan

Hyogo Medical University Hospital

Hyôgo, 663-8501

Japan

Saitama Medical University Hospital

Iruma-gun, 350-0495

Japan

Tokai University Hospital

Kanagawa, 259-1193

Japan

Kanazawa University Hospital

Kanazawa, 920 8641

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Matsuyama Red Cross Hospital

Matsuyama, 790-8524

Japan

National Hospital Organization Nagasaki Medical Center

Nagasaki, 856-8562

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, 545 8586

Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, 003-0804

Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa, 377-0280

Japan

Japanese Red Cross Medical Center

Shibuya-ku, 150-8935

Japan

Shizuoka Cancer Center

Sunto Gun, 411 8777

Japan

Fujita Health University Hospital

Toyoake, 470-1192

Japan

Yamagata University Hospital

Yamagata, 990 2331

Japan

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506

Japan

VUMC Amsterdam

Amsterdam, 1081 HV

Netherlands

Gelre Ziekenhuis

Apeldoorn, 7334 DZ

Netherlands

Reinier de Graaf Gasthuis

Delft, 2625 AD

Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3435 CM

Netherlands

Zuyderland Medical Center

Sittard-Geleen, 6162 BG

Netherlands

Oslo University Hospital HF Ulleval sykehus

Oslo, 0450

Norway

St. Olavs Hospital

Trondheim, 7030

Norway

Wojewodzki Szpital Kliniczny w Bialej Podlaskiej

Biała Podlaska, 21 500

Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, 36-200

Poland

Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168

Poland

Pratia Onkologia Katowice

Katowice, 40 519

Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, 93 513

Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20 090

Poland

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

Lublin, 20-081

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569

Poland

Uniwersyteckie Centrum Kliniczne

Warsaw, 02 097

Poland

Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze

Zielona Góra, 65 046

Poland

Uls Braga - Hosp. Braga

Braga, 4710-243

Portugal

Champalimaud Foundation Champalimaud Centre

Lisbon, 1400-038

Portugal

Uls Hosp Sao Joao

Porto, 4200 319

Portugal

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

Porto, 4200072

Portugal

Dong-A University Hospital

Busan, 49201

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Kyungpook National University Hospital

Daegu, 41944

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Chonnam National University Hwasun Hospital

Hwasun, 58128

South Korea

Gachon University Gil Medical Center

Incheon, 21565

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591

South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Institut Catala d Oncologia L Hospitalet

Barcelona, 08908

Spain

Hosp. Univ. Virgen de Las Nieves

Granada, 18014

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Univ. La Paz

Madrid, 28046

Spain

Hosp Univ Hm Sanchinarro

Madrid, 28050

Spain

Hosp. Univ. Son Espases

Palma de Mallorca, 07120

Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Hosp. Mutua Terrassa

Terrassa, 08221

Spain

Hosp. Clinico Univ. de Valencia

Valencia, 46010

Spain

Falu Lasarett

Falun, 791 82

Sweden

Skanes universitetssjukhus

Lund, 221 85

Sweden

Universitetssjukhuset Orebro

Örebro, 701 85

Sweden

Karolinska University Hospital Huddinge

Stockholm, 141 86

Sweden

Inselspital Universitatsspital Bern

Bern, 3010

Switzerland

Kantonsspital St Gallen

Sankt Gallen, 9007

Switzerland

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

Ankara, 06620

Turkey (Türkiye)

Liv Hospital Ankara

Ankara, 06680

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07025

Turkey (Türkiye)

Pamukkale University Medical Faculty

Denizli, 20160

Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, 34214

Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, 35340

Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, 55280

Turkey (Türkiye)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW

United Kingdom

Blackpool Victoria Hospital

Blackpool, FY3 8NR

United Kingdom

University Hospitals Bristol and Weston

Bristol, BS1 3NU

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 0QQ

United Kingdom

Kent and Canterbury Hospital

Canterbury, CT1 3NG

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

University College London Hospitals

London, NW1 2BU

United Kingdom

Imperial College Healthcare

London, W12 0HS

United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP

United Kingdom