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 (MajesTEC-7)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Lenalidomide; Drug: Teclistamab; Drug: Daratumumab; Drug: Dexamethasone; Drug: Talquetamab

Detailed Description

Teclistamab is a full-size, immunoglobin G4 proline, alanine, alanine (IgG4-PAA) bispecific antibody that targets the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). Talquetamab is a full-size, humanized IgG4-PAA bispecific antibody designed to target the CD3 receptor complex on T cells and G protein-coupled receptor class C group 5 member D (GPRC5D), which is a 7-transmembrane receptor protein that is classified as a type C G protein-coupled receptor. DRd is an approved regimen for the treatment of participants with newly diagnosed, transplant-ineligible multiple myeloma. The primary hypothesis of this study is that Tec-DR and Tal-DR will significantly improve progression free survival (PFS) or the rate of sustained minimal residual disease (MRD)-negative complete response (CR) (greater than [>]12 months) compared with DRd in participants with newly diagnosed multiple myeloma who are ineligible or not intended for autologous stem cell transplant (ASCT) as initial therapy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. Safety Assessment includes adverse events (AEs), laboratory test results, vital sign measurements, physical examination findings, assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade, and immune effector cell associated encephalopathy (ICE) score (Tec-DR and Tal-DR).

• Study Type: Interventional
• Enrollment (Estimated): 1590
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Active, not recruiting
    • Royal Prince Alfred Hospital
  • Geelong, Australia, 3220
    • Active, not recruiting
    • Barwon Health - University Hospital Geelong
  • Liverpool, Australia, 2170
    • Active, not recruiting
    • Liverpool Hospital
  • Nedlands, Australia, 6009
    • Active, not recruiting
    • Sir Charles Gairdner Hospital
  • New South Wales, Australia, 2298
    • Active, not recruiting
    • Calvary Mater Newcastle Hospital
  • Wollongong, Australia, 2500
    • Active, not recruiting
    • Wollongong Hospital
  • Woolloongabba, Australia, 4102
    • Active, not recruiting
    • Princess Alexandra Hospital
• Austria
  • Linz, Austria, 4020
    • Active, not recruiting
    • Ordensklinikum Linz Gmbh Elisabethinen
  • Salzburg, Austria, 5020
    • Active, not recruiting
    • SCRI CCCIT gem GmbH
  • Vienna, Austria, 1140
    • Active, not recruiting
    • Hanusch Krankenhaus
  • Vienna, Austria, 1090
    • Active, not recruiting
    • Medical University Vienna
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Institut Jules Bordet
  • Antwerp, Belgium, 2030
    • Recruiting
    • ZAS Cadix
  • Antwerp, Belgium, 2610
    • Completed
    • ZAS Augustinus
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
  • Haine Saint Paul La Louviere, Belgium, 7100
    • Completed
    • Jolimont
  • Kortrijk, Belgium, 8500
    • Recruiting
    • Az Groeninge
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
• Brazil
  • Barretos, Brazil, 14784 400
    • Completed
    • Fundacao Pio XII
  • Belo Horizonte, Brazil, 30150 320
    • Active, not recruiting
    • Santa Casa de Misericordia de Belo Horizonte
  • Curitiba, Brazil, 81520-060
    • Active, not recruiting
    • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
  • Fortaleza, Brazil, 60430-230
    • Active, not recruiting
    • Instituto do Câncer do Ceará
  • Natal, Brazil, 59062-000
    • Active, not recruiting
    • Liga Norte Riograndense contra o cancer
  • Niterói, Brazil, 24030-103
    • Active, not recruiting
    • Complexo Hospitalar de Niteroi
  • Porto Alegre, Brazil, 90035 903
    • Active, not recruiting
    • Hospital de Clínicas de Porto Alegre
  • Ribeirão Preto, Brazil, 14051140
    • Active, not recruiting
    • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Salvador, Brazil, 41253-190
    • Active, not recruiting
    • IDOR - Regional Bahia
  • São Paulo, Brazil, 04537 081
    • Active, not recruiting
    • Clinica Medica Sao Germano LTDA
  • São Paulo, Brazil, 01409-902
    • Active, not recruiting
    • Hospital Nove de Julho
  • São Paulo, Brazil, 05403 000
    • Active, not recruiting
    • Hospital das Clínicas da Faculdade de Medicina da USP
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Active, not recruiting
      • Arthur J E Child Comprehensive Cancer Centre
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Completed
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4E6
      • Active, not recruiting
      • British Columbia Cancer Agency
  • Ontario
    • Oshawa, Ontario, Canada, L1G-2B9
      • Recruiting
      • Lakeridge Health Oshawa
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Active, not recruiting
      • CHU de Quebec L Hotel Dieu de Quebec
• China
  • Beijing, China, 100034
    • Active, not recruiting
    • Peking University First Hospital
  • Beijing, China, 100006
    • Active, not recruiting
    • Peking Union Medical College Hospital
  • Beijing, China, 100051
    • Active, not recruiting
    • Beijing Tongren Hospital CMU
  • Changchun, China, 130061
    • Active, not recruiting
    • The First Hospital of Jilin University
  • Changsha, China, 410011
    • Active, not recruiting
    • The Second Xiangya Hospital of Central South Hospital
  • Changzhou, China, 213004
    • Active, not recruiting
    • Changzhou No 2 Peoples Hospital
  • Chaoyang District, China, 100020
    • Active, not recruiting
    • Beijing Chaoyang Hospital
  • Chengdu, China, 610072
    • Active, not recruiting
    • Sichuan Provincial Peoples Hospital
  • Chongqing, China, 400030
    • Active, not recruiting
    • Chongqing University Cancer Hospital
  • Fuzhou, China, 350001
    • Active, not recruiting
    • Fujian Meidical University Union Hospital
  • Guangzhou, China, 510515
    • Active, not recruiting
    • Nanfang Hospital
  • Guangzhou, China, 511363
    • Active, not recruiting
    • Sun Yat -Sen University Cancer Center
  • Hangzhou, China, 310003
    • Active, not recruiting
    • No.1 Affiliated Hospital, Medical College of Zhejiang University
  • Hangzhou, China, 310003
    • Active, not recruiting
    • The Second Affiliated Hospital of Zhejiang University
  • Harbin, China, 150081
    • Completed
    • Harbin Medical University Cancer Hospital
  • Jinan, China, 250012
    • Completed
    • Qilu Hospital of Shandong University
  • Nanchang, China, 330006
    • Active, not recruiting
    • The First Affliated Hospital Of Nanchang University
  • Nanjing, China, 210008
    • Active, not recruiting
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 214135
    • Active, not recruiting
    • Zhongda Hospital Southeast University
  • Nanning, China, 530021
    • Active, not recruiting
    • The first affiliated hospital of Guangxi Medical University
  • Shanghai, China, 200434
    • Active, not recruiting
    • Shanghai Fourth People s Hospital
  • Shanghai, China, 200127
    • Active, not recruiting
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200025
    • Active, not recruiting
    • Ruijin Hospital Shanghai Jiao Tong University
  • Shenyang, China, 110022
    • Active, not recruiting
    • Shengjing Hospital Of China Medical University
  • Shenzhen, China, 518036
    • Active, not recruiting
    • Peking University Shenzhen Hospital
  • Tianjin, China, 300060
    • Active, not recruiting
    • Tianjin Medical University Cancer Institute and Hospital
  • Tianjin, China, 301609
    • Active, not recruiting
    • Institute of Hematology and Blood Diseases Hospital
  • Wenzhou, China, 325000
    • Active, not recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430032
    • Active, not recruiting
    • Wuhan Tongji Hospital Tongji Medical College
  • Xi'an, China, 710004
    • Active, not recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China, 361003
    • Active, not recruiting
    • The First Affiliated Hospital of Xiamen University
  • Zhengzhou, China, 450008
    • Active, not recruiting
    • Henan Cancer Hospital
• Czechia
  • Brno-Bohunice, Czechia, 625 00
    • Active, not recruiting
    • Fakultni nemocnice Brno
  • Hradec Králové, Czechia, 500 05
    • Active, not recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Active, not recruiting
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 708 52
    • Active, not recruiting
    • Fakultni nemocnice Ostrava
  • Pilsen, Czechia, 304 60
    • Active, not recruiting
    • Fakultni Nemocnice Plzen
  • Prague, Czechia, 128 08
    • Active, not recruiting
    • VFN v Praze
• Denmark
  • Aalborg, Denmark, 9000
    • Active, not recruiting
    • Aalborg University Hospital
  • Herning, Denmark, 7400
    • Active, not recruiting
    • Regionshospitalet Godstrup
  • Roskilde, Denmark
    • Active, not recruiting
    • Zealand University Hospital
  • Vejle, Denmark, 7100
    • Active, not recruiting
    • Vejle Sygehus
• France
  • Créteil, France, 94010
    • Recruiting
    • CHU Henri Mondor
  • Lille, France, 59000
    • Active, not recruiting
    • Hôpital Claude Huriez
  • Lyon, France, 69002
    • Active, not recruiting
    • Hospices Civils de Lyon HCL
  • Nantes, France, 44093
    • Active, not recruiting
    • CHU Nantes
  • Paris, France, 75571
    • Completed
    • CHU Hopital Saint Antoine
  • Pessac, France, 33604
    • Active, not recruiting
    • CHU de Bordeaux - Hospital Haut-Leveque
  • Poitiers, France, 86021
    • Active, not recruiting
    • CHU Poitiers - Hôpital la Milétrie
  • Rennes, France, 35033
    • Active, not recruiting
    • CHU De Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67200
    • Active, not recruiting
    • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
  • Toulouse, France, 31059
    • Active, not recruiting
    • Institut Universitaire du Cancer Toulouse Oncopole
• Germany
  • Berlin, Germany, 13125
    • Active, not recruiting
    • Helios Kliniken Berlin Buch Gmbh
  • Essen, Germany, 45147
    • Recruiting
    • Med. Universitatsklinik Essen
  • Halle, Germany, 06120
    • Active, not recruiting
    • Universitaetsklinikum Halle Saale
  • Hamburg, Germany, 20251
    • Active, not recruiting
    • Universitaetsklinik Hamburg-Eppendorf
  • Nuremberg, Germany, 90419
    • Active, not recruiting
    • Klinikum Nuernberg Nord
  • Tübingen, Germany, 72076
    • Active, not recruiting
    • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Würzburg, Germany, 97080
    • Active, not recruiting
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens Attica, Greece, 115 28
    • Active, not recruiting
    • Alexandra General Hospital of Athens
  • Thessaloniki, Greece, 546 39
    • Active, not recruiting
    • Theageneio Cancer Hospital
  • Thessalonikis, Greece, 570 10
    • Active, not recruiting
    • G Papanikolaou Hospital of Thessaloniki
• Israel
  • Beersheba, Israel, 8457108
    • Active, not recruiting
    • Soroka Medical Center
  • Haifa, Israel, 3109601
    • Active, not recruiting
    • Rambam Medical Center
  • Jerusalem, Israel, 9103102
    • Active, not recruiting
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel, 49100
    • Active, not recruiting
    • Rabin
  • Ramat Gan, Israel, 52621
    • Active, not recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Active, not recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • ASST Papa Giovanni XXIII Bergamo
  • Bologna, Italy, 40138
    • Recruiting
    • A O U Sant Orsola Malpighi
  • Florence, Italy, 50134
    • Recruiting
    • Careggi University Hospital
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Naples, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
  • Pavia, Italy, 27100
    • Recruiting
    • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
  • Roma, Italy, 00133
    • Recruiting
    • Universita Degli Studi di Roma Tor Vergata
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Recruiting
    • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
• Japan
  • Bunkyō City, Japan, 113 8431
    • Active, not recruiting
    • Juntendo University Hospital
  • Chiba, Japan, 260 0801
    • Active, not recruiting
    • Chiba Cancer Center
  • Chiba, Japan, 296-0041
    • Active, not recruiting
    • Kameda Medical Center
  • Higashiibaraki-gun, Japan, 311-3193
    • Active, not recruiting
    • National Hospital Organization Mito Medical Center
  • Hirakata, Japan, 573 1191
    • Active, not recruiting
    • Kansai Medical University Hospital
  • Hyôgo, Japan, 663-8501
    • Active, not recruiting
    • Hyogo Medical University Hospital
  • Iruma-gun, Japan, 350-0495
    • Active, not recruiting
    • Saitama Medical University Hospital
  • Kanagawa, Japan, 259-1193
    • Active, not recruiting
    • Tokai University Hospital
  • Kanazawa, Japan, 920 8641
    • Active, not recruiting
    • Kanazawa University Hospital
  • Kumamoto, Japan, 860-8556
    • Active, not recruiting
    • Kumamoto University Hospital
  • Matsuyama, Japan, 790-8524
    • Active, not recruiting
    • Matsuyama Red Cross Hospital
  • Nagasaki, Japan, 856-8562
    • Active, not recruiting
    • National Hospital Organization Nagasaki Medical Center
  • Okayama, Japan, 701-1192
    • Active, not recruiting
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545 8586
    • Active, not recruiting
    • Osaka Metropolitan University Hospital
  • Sapporo, Japan, 003-0804
    • Active, not recruiting
    • National Hospital Organization Hokkaido Cancer Center
  • Shibukawa, Japan, 377-0280
    • Active, not recruiting
    • National Hospital Organization Shibukawa Medical Center
  • Shibuya-ku, Japan, 150-8935
    • Active, not recruiting
    • Japanese Red Cross Medical Center
  • Sunto Gun, Japan, 411 8777
    • Active, not recruiting
    • Shizuoka Cancer Center
  • Toyoake, Japan, 470-1192
    • Active, not recruiting
    • Fujita Health University Hospital
  • Yamagata, Japan, 990 2331
    • Active, not recruiting
    • Yamagata University Hospital
  • Yamanashi, Japan, 400-8506
    • Active, not recruiting
    • Yamanashi Prefectural Central Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • VUMC Amsterdam
  • Apeldoorn, Netherlands, 7334 DZ
    • Recruiting
    • Gelre Ziekenhuis
  • Delft, Netherlands, 2625 AD
    • Recruiting
    • Reinier de Graaf Gasthuis
  • Nieuwegein, Netherlands, 3435 CM
    • Recruiting
    • St. Antonius Ziekenhuis Nieuwegein
  • Sittard-Geleen, Netherlands, 6162 BG
    • Recruiting
    • Zuyderland Medical Center
• Norway
  • Oslo, Norway, 0450
    • Active, not recruiting
    • Oslo University Hospital HF Ulleval sykehus
  • Trondheim, Norway, 7030
    • Active, not recruiting
    • St. Olavs Hospital
• Poland
  • Biała Podlaska, Poland, 21 500
    • Completed
    • Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
  • Brzozów, Poland, 36-200
    • Active, not recruiting
    • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
  • Bydgoszcz, Poland, 85-168
    • Active, not recruiting
    • Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
  • Katowice, Poland, 40 519
    • Active, not recruiting
    • PRATIA Onkologia Katowice
  • Kielce, Poland, 25 734
    • Active, not recruiting
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lodz, Poland, 93 513
    • Active, not recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
  • Lublin, Poland, 20-081
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
  • Lublin, Poland, 20 090
    • Active, not recruiting
    • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
  • Poznan, Poland, 60-569
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Warsaw, Poland, 02 097
    • Active, not recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Zielona Góra, Poland, 65 046
    • Completed
    • Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
• Portugal
  • Braga, Portugal, 4710-243
    • Active, not recruiting
    • Uls Braga - Hosp. Braga
  • Lisbon, Portugal, 1400-038
    • Active, not recruiting
    • Champalimaud Foundation Champalimaud Centre
  • Porto, Portugal, 4200 319
    • Active, not recruiting
    • Uls Hosp Sao Joao
  • Porto, Portugal, 4200072
    • Active, not recruiting
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
• South Korea
  • Busan, South Korea, 49241
    • Active, not recruiting
    • Pusan National University Hospital
  • Busan, South Korea, 49201
    • Active, not recruiting
    • Dong-A University Hospital
  • Daegu, South Korea, 41944
    • Active, not recruiting
    • Kyungpook National University Hospital
  • Goyang-si, South Korea, 10408
    • Active, not recruiting
    • National Cancer Center
  • Hwasun, South Korea, 58128
    • Active, not recruiting
    • Chonnam National University Hwasun Hospital
  • Incheon, South Korea, 21565
    • Active, not recruiting
    • Gachon University Gil Medical Center
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 05505
    • Active, not recruiting
    • Asan Medical Center
  • Seoul, South Korea, 06591
    • Active, not recruiting
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Seoul, South Korea, 03722
    • Active, not recruiting
    • Severance Hospital Yonsei University Health System
• Spain
  • Badalona, Spain, 08916
    • Active, not recruiting
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08041
    • Active, not recruiting
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Hosp Univ Vall D Hebron
  • Barcelona, Spain, 08908
    • Active, not recruiting
    • Institut Catala d Oncologia L Hospitalet
  • Granada, Spain, 18014
    • Active, not recruiting
    • Hosp. Univ. Virgen de Las Nieves
  • Jerez de la Frontera, Spain, 11407
    • Active, not recruiting
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28050
    • Active, not recruiting
    • Hosp Univ Hm Sanchinarro
  • Palma de Mallorca, Spain, 07120
    • Active, not recruiting
    • Hosp. Univ. Son Espases
  • Pozuelo de Alarcón, Spain, 28223
    • Active, not recruiting
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Active, not recruiting
    • Hosp Clinico Univ de Salamanca
  • Terrassa, Spain, 08221
    • Active, not recruiting
    • Hosp. Mutua Terrassa
  • Valencia, Spain, 46010
    • Active, not recruiting
    • Hosp. Clinico Univ. de Valencia
• Sweden
  • Falun, Sweden, 791 82
    • Active, not recruiting
    • Falu Lasarett
  • Lund, Sweden, 221 85
    • Active, not recruiting
    • Skånes universitetssjukhus
  • Stockholm, Sweden, 141 86
    • Active, not recruiting
    • Karolinska University Hospital Huddinge
  • Örebro, Sweden, 701 85
    • Active, not recruiting
    • Universitetssjukhuset Orebro
• Switzerland
  • Bern, Switzerland, 3010
    • Active, not recruiting
    • Inselspital Universitatsspital Bern
  • Sankt Gallen, Switzerland, 9007
    • Active, not recruiting
    • Kantonsspital St Gallen
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06680
    • Active, not recruiting
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06200
    • Active, not recruiting
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06620
    • Active, not recruiting
    • Ankara Universitesi Tip Fakultesi Cebeci Arastirma Ve Uygulama Hastanesi
  • Antalya, Turkey (Türkiye), 07025
    • Active, not recruiting
    • Memorial Antalya Hospital
  • Denizli, Turkey (Türkiye), 20160
    • Completed
    • Pamukkale University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34214
    • Active, not recruiting
    • Medipol Mega Universite Hastanesi
  • Izmir, Turkey (Türkiye), 35340
    • Completed
    • Dokuz Eylul University Medical Faculty
  • Samsun, Turkey (Türkiye), 55280
    • Active, not recruiting
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Recruiting
    • University Hospitals Birmingham NHS Foundation Trust
  • Blackpool, United Kingdom, FY3 8NR
    • Recruiting
    • Blackpool Victoria Hospital
  • Bristol, United Kingdom, BS1 3NU
    • Recruiting
    • Bristol NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrooke's Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Recruiting
    • Kent and Canterbury Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Western General Hospital
  • London, United Kingdom, NW1 2BU
    • Recruiting
    • University College London Hospitals
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Imperial College Healthcare
  • Wolverhampton, United Kingdom, WV10 0QP
    • Recruiting
    • New Cross Hospital
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Recruiting
      • Banner MD Anderson Cancer Center
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona Cancer Center
  • California
    • Clovis, California, United States, 93611
      • Recruiting
      • Ucsf Fresno
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Duarte
    • Irvine, California, United States, 92618
      • Recruiting
      • City of Hope Orange County Lennar Foundation Cancer Center
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90067
      • Recruiting
      • Valkyrie Clinical Trials
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • University of Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • ChristianaCare Helen F Graham Cancer Center and Research Institute
  • Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Memorial Healthcare System
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Medical Group Blood & Marrow Transplant at Orlando
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Recruiting
      • City of Hope Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Medical Center
    • Maywood, Illinois, United States, 60153
      • Recruiting
      • Loyola University Medical Center
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Recruiting
      • University of Iowa Health Care
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Recruiting
      • LSUHSC Shreveport Feist-Weiller Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Recruiting
      • Johns Hopkins University School of Medicine JHUSOM
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Center for Cancer and Blood Disorders
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Cancer And Hematology Centers of Western Michigan PC
    • Novi, Michigan, United States, 48374
      • Recruiting
      • Henry Ford Providence Novi Hospital
    • Southfield, Michigan, United States, 48075
      • Recruiting
      • Henry Ford Providence Southfield CK Potluri Cancer Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Recruiting
      • Midamerica Cancer Care
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Nebraska Cancer Specialists
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Recruiting
      • CHRISTUS St. Vincent Regional Cancer Center
  • New York
    • East Syracuse, New York, United States, 13057
      • Recruiting
      • Hematology-Oncology Associates of CNY
    • Lake Success, New York, United States, 11042
      • Recruiting
      • Northwell Health Cancer Institute
    • Mineola, New York, United States, 11500
      • Recruiting
      • NYU Langone Hospital Long Island
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • Recruiting
      • Perlmutter Cancer Center at NYU Langone Health
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Novant Health
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Durham VAMC
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Novant Health Zimmer Cancer Institute
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Novant Health Forsyth Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital Cancer Center
    • Cincinnati, Ohio, United States, 45236
      • Recruiting
      • Oncology Hematology Care
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Main Campus
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University- James Cancer Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S Hershey Medical Ctr
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • Allegheny Health Network
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • MUSC-Hollings Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Henry-Joyce Cancer Clinic
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
    • Lubbock, Texas, United States, 79410
      • Recruiting
      • Joe Arrington Cancer Research Treatment Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Recruiting
      • Utah Cancer Specialists
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Completed
      • University of Virginia
    • Fort Belvoir, Virginia, United States, 22060
      • Recruiting
      • Alexander T. Augusta Military Medical Center
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates Brock Cancer Center
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University Medical Center
    • Richmond, Virginia, United States, 23249
      • Recruiting
      • Richmond VA Medical Center
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR); Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.	Drug: Lenalidomide; Lenalidomide will be administered orally.; Drug: Teclistamab; Teclistamab will be administered as SC injection.; Other Names: JNJ-64007957; Drug: Daratumumab; Daratumumab will be administered as SC injection.
Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR); Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.	Drug: Lenalidomide; Lenalidomide will be administered orally.; Drug: Daratumumab; Daratumumab will be administered as SC injection.; Drug: Talquetamab; Talquetamab will be administered as SC injection.; Other Names: JNJ-64407564
Active Comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd); Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.	Drug: Lenalidomide; Lenalidomide will be administered orally.; Drug: Daratumumab; Daratumumab will be administered as SC injection.; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously (IV).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.	From randomization to the date of disease progression or death (Up to 09 years)
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)	12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)	The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	From baseline up to 9 years
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.	Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	From baseline up to 9 years
Very Good Partial Response (VGPR) or Better	VGPR or better is defined as the percentage of participants achieving VGPR and CR (including stringent complete response [sCR]) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.	From randomization up to 09 years
Complete Response (CR) or Better	CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.	From randomization up to 09 years
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)	Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by NGS with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.	From randomization up to 09 years
MRD-negative CR	MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better.	From randomization up to 09 years
Progression Free Survival on Next-line Therapy (PFS2)	PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.	From randomization up to 09 years
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause.	From randomization to the date of death (up to 09 years)
Number of Participants with Adverse Events (AEs) by Severity	An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.	From randomization up to 09 years
Number of Participants with Abnormalities in Laboratory Parameters	Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.	From randomization up to 09 years
Number of Participants with Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.	From randomization up to 09 years
Number of Participants with Abnormalities in Physical Examination	Number of participants with abnormalities in physical examination will be reported.	From randomization up to 09 years
Number of Participants with Abnormalities in Electrocardiogram (ECG)	Number of participants with abnormalities in ECG will be reported.	From randomization up to 09 years
Serum Concentrations of Teclistamab and Talquetamab	Serum samples will be analyzed to determine concentrations of teclistamab and talquetamab using validated, specific, and sensitive methods.	From randomization up to 09 years
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab	Number of participants with ADAs to teclistamab and talquetamab will be reported.	From randomization up to 09 years
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL	Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change.	From randomization up to 09 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): April 30, 2031
• Study Completion (Estimated): October 28, 2033

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Dexamethasone; daratumumab; talquetamab
• Other Study ID Numbers: CR109237; 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation); 64007957MMY3005 (Other Identifier: Janssen Research & Development, LLC); 2022-000909-28 (EudraCT Number); 2023-503442-30-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No