Multiple MyelomaPhase 3MajesTEC-7NCT05552222

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 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 270 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Teclistamab, Daratumumab and Lenalidomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,590 participants
Where: 270 sitesin 25 countries
Study dates: 25 Oct 2022to 28 Oct 2033
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

270 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Country

City, postcode or hospital

Sites recruiting now only

270 sites in 25 countries

United States67 sites, 65 recruiting

University of Michigan
Ann Arbor, Michigan, 48109
Recruiting
Johns Hopkins University School of Medicine JHUSOM
Baltimore, Maryland, 21231
Recruiting
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Recruiting
MUSC-Hollings Cancer Center
Charleston, South Carolina, 29425
Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Recruiting
Novant Health
Charlotte, North Carolina, 28204
Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Completed
University Of Illinois Medical Center
Chicago, Illinois, 60612
Recruiting
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45236
Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Recruiting
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Recruiting
UCSF Fresno
Clovis, California, 93611
Recruiting
The Ohio State University- James Cancer Hospital
Columbus, Ohio, 43210
Recruiting
OhioHealth
Columbus, Ohio, 43214
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Recruiting
Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
Recruiting
City of Hope Duarte
Duarte, California, 91010
Recruiting
Durham VAMC
Durham, North Carolina, 27705
Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
Recruiting
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057
Recruiting
University of Connecticut
Farmington, Connecticut, 06030
Recruiting
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, 22060
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Recruiting
Cancer And Hematology Centers of Western Michigan PC
Grand Rapids, Michigan, 49503
Recruiting
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, 17033
Recruiting
Memorial Healthcare System
Hollywood, Florida, 33021
Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Recruiting
MidAmerica Cancer Care
Kansas City, Missouri, 64132
Completed
Northwell Health Cancer Institute
Lake Success, New York, 11042
Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40207
Recruiting
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410
Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Recruiting
NYU Langone Hospital Long Island
Mineola, New York, 11500
Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Recruiting
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Recruiting
Weill Cornell Medical College
New York, New York, 10065
Recruiting
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, 19713
Recruiting
City of Hope Cancer Center
Newnan, Georgia, 30265
Recruiting
Virginia Oncology Associates Brock Cancer Center
Norfolk, Virginia, 23502
Recruiting
Henry Ford Providence Novi Hospital
Novi, Michigan, 48374
Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Recruiting
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, 32804
Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Recruiting
Richmond VA Medical Center
Richmond, Virginia, 23249
Recruiting
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Recruiting
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Recruiting
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport, Louisiana, 71103
Recruiting
Henry Ford Providence Southfield CK Potluri Cancer Center
Southfield, Michigan, 48075
Recruiting
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405
Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Recruiting
University of Iowa Health Care
Waukee, Iowa, 50263
Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Recruiting
Novant Health Zimmer Cancer Institute
Wilmington, North Carolina, 28401
Recruiting
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Recruiting

Other trials in United States

China32 sites

Peking Union Medical College Hospital
Beijing, 100006
Active, not recruiting
Peking University First Hospital
Beijing, 100034
Active, not recruiting
Beijing Tongren Hospital CMU
Beijing, 100051
Active, not recruiting
The First Hospital of Jilin University
Changchun, 130061
Active, not recruiting
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011
Active, not recruiting
Changzhou No 2 Peoples Hospital
Changzhou, 213004
Active, not recruiting
Beijing Chaoyang Hospital
Chaoyang District, 100020
Active, not recruiting
Sichuan Provincial Peoples Hospital
Chengdu, 610072
Active, not recruiting
Chongqing University Cancer Hospital
Chongqing, 400030
Active, not recruiting
Fujian Meidical University Union Hospital
Fuzhou, 350001
Active, not recruiting
Nanfang Hospital
Guangzhou, 510515
Active, not recruiting
Sun Yat -Sen University Cancer Center
Guangzhou, 511363
Active, not recruiting
No.1 Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, 310003
Active, not recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, 310003
Active, not recruiting
Harbin medical university cancer hospital
Harbin, 150081
Completed
Qilu Hospital of Shandong University
Jinan, 250012
Completed
The First Affliated Hospital Of Nanchang University
Nanchang, 330006
Active, not recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Active, not recruiting
Zhongda Hospital Southeast University
Nanjing, 214135
Active, not recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021
Active, not recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
Active, not recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127
Active, not recruiting
Shanghai Fourth People s Hospital
Shanghai, 200434
Active, not recruiting
Shengjing Hospital Of China Medical University
Shenyang, 110022
Active, not recruiting
Peking University Shenzhen Hospital
Shenzhen, 518036
Active, not recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Active, not recruiting
Institute of Hematology and Blood Diseases Hospital
Tianjin, 301609
Active, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Active, not recruiting
Wuhan Tongji Hospital Tongji Medical College
Wuhan, 430032
Active, not recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
Active, not recruiting
The first affiliated hospital of xiamen university
Xiamen, 361003
Active, not recruiting
Henan Cancer Hospital
Zhengzhou, 450008
Active, not recruiting

Other trials in China

Japan21 sites

Juntendo University Hospital
Bunkyō City, 113 8431
Active, not recruiting
Chiba Cancer Center
Chiba, 260 0801
Active, not recruiting
Kameda Medical Center
Chiba, 296-0041
Active, not recruiting
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193
Active, not recruiting
Kansai Medical University Hospital
Hirakata, 573 1191
Active, not recruiting
Hyogo Medical University Hospital
Hyôgo, 663-8501
Active, not recruiting
Saitama Medical University Hospital
Iruma-gun, 350-0495
Active, not recruiting
Tokai University Hospital
Kanagawa, 259-1193
Active, not recruiting
Kanazawa University Hospital
Kanazawa, 920 8641
Active, not recruiting
Kumamoto University Hospital
Kumamoto, 860-8556
Active, not recruiting
Matsuyama Red Cross Hospital
Matsuyama, 790-8524
Active, not recruiting
National Hospital Organization Nagasaki Medical Center
Nagasaki, 856-8562
Active, not recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Active, not recruiting
Osaka Metropolitan University Hospital
Osaka, 545 8586
Active, not recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, 003-0804
Active, not recruiting
National Hospital Organization Shibukawa Medical Center
Shibukawa, 377-0280
Active, not recruiting
Japanese Red Cross Medical Center
Shibuya-ku, 150-8935
Active, not recruiting
Shizuoka Cancer Center
Sunto Gun, 411 8777
Active, not recruiting
Fujita Health University Hospital
Toyoake, 470-1192
Active, not recruiting
Yamagata University Hospital
Yamagata, 990 2331
Active, not recruiting
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506
Active, not recruiting

Other trials in Japan

Spain14 sites

Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Active, not recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
Active, not recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041
Active, not recruiting
Institut Catala d Oncologia L Hospitalet
Barcelona, 08908
Active, not recruiting
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Active, not recruiting
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
Active, not recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
Active, not recruiting
Hosp. Univ. La Paz
Madrid, 28046
Active, not recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
Active, not recruiting
Hosp. Univ. Son Espases
Palma de Mallorca, 07120
Active, not recruiting
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223
Active, not recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Active, not recruiting
Hosp. Mutua Terrassa
Terrassa, 08221
Active, not recruiting
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Active, not recruiting

Other trials in Spain

Brazil12 sites

Fundacao Pio XII
Barretos, 14784 400
Completed
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150 320
Active, not recruiting
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, 81520-060
Active, not recruiting
Instituto Do Cancer Do Ceara
Fortaleza, 60430-230
Active, not recruiting
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000
Active, not recruiting
Complexo Hospitalar de Niteroi
Niterói, 24030-103
Active, not recruiting
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903
Active, not recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, 14051140
Active, not recruiting
IDOR - Regional Bahia
Salvador, 41253-190
Active, not recruiting
Hospital Nove de Julho
São Paulo, 01409-902
Active, not recruiting
Clinica Medica Sao Germano LTDA
São Paulo, 04537 081
Active, not recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403 000
Active, not recruiting

Other trials in Brazil

Poland11 sites

Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
Biała Podlaska, 21 500
Completed
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200
Active, not recruiting
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Active, not recruiting
Pratia Onkologia Katowice
Katowice, 40 519
Active, not recruiting
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734
Active, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93 513
Active, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20 090
Active, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-081
Active, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
Active, not recruiting
Uniwersyteckie Centrum Kliniczne
Warsaw, 02 097
Active, not recruiting
Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
Zielona Góra, 65 046
Completed

Other trials in Poland

South Korea11 sites

Dong-A University Hospital
Busan, 49201
Active, not recruiting
Pusan National University Hospital
Busan, 49241
Active, not recruiting
Kyungpook National University Hospital
Daegu, 41944
Active, not recruiting
National Cancer Center
Goyang-si, 10408
Active, not recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Active, not recruiting
Gachon University Gil Medical Center
Incheon, 21565
Active, not recruiting
Seoul National University Hospital
Seoul, 03080
Active, not recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Active, not recruiting
Asan Medical Center
Seoul, 05505
Active, not recruiting
Samsung Medical Center
Seoul, 06351
Active, not recruiting
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
Active, not recruiting

Other trials in South Korea

France10 sites

CHU Henri Mondor
Créteil, 94010
Completed
Hopital Claude Huriez
Lille, 59000
Active, not recruiting
Hospices Civils de Lyon HCL
Lyon, 69002
Active, not recruiting
CHU Nantes
Nantes, 44093
Active, not recruiting
CHU Hopital Saint Antoine
Paris, 75571
Completed
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604
Active, not recruiting
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021
Active, not recruiting
CHU de Rennes - Hopital Pontchaillou
Rennes, 35033
Active, not recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200
Active, not recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Active, not recruiting

Other trials in France

Italy9 sites

ASST Papa Giovanni XXIII Bergamo
Bergamo, 24127
Active, not recruiting
A O U Sant Orsola Malpighi
Bologna, 40138
Active, not recruiting
Careggi University Hospital
Florence, 50134
Active, not recruiting
Ospedale San Raffaele
Milan, 20132
Active, not recruiting
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples, 80131
Active, not recruiting
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, 27100
Active, not recruiting
Universita Degli Studi di Roma Tor Vergata
Roma, 00133
Active, not recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Active, not recruiting
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126
Active, not recruiting

Other trials in Italy

United Kingdom9 sites

University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
Completed
Blackpool Victoria Hospital
Blackpool, FY3 8NR
Active, not recruiting
Bristol NHS Foundation Trust
Bristol, BS1 3NU
Active, not recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Active, not recruiting
Kent and Canterbury Hospital
Canterbury, CT1 3NG
Active, not recruiting
Western General Hospital
Edinburgh, EH4 2XU
Active, not recruiting
University College London Hospitals
London, NW1 2BU
Active, not recruiting
Imperial College Healthcare
London, W12 0HS
Active, not recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
Active, not recruiting

Other trials in United Kingdom

Turkey (Türkiye)8 sites

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
Active, not recruiting
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620
Active, not recruiting
Liv Hospital Ankara
Ankara, 06680
Active, not recruiting
Memorial Antalya Hospital
Antalya, 07025
Active, not recruiting
Pamukkale University Medical Faculty
Denizli, 20160
Completed
Medipol Mega Universite Hastanesi
Istanbul, 34214
Active, not recruiting
Dokuz Eylul University Medical Faculty
Izmir, 35340
Completed
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55280
Active, not recruiting

Other trials in Turkey (Türkiye)

Australia7 sites

Royal Prince Alfred Hospital
Camperdown, 2050
Active, not recruiting
Barwon Health - University Hospital Geelong
Geelong, 3220
Active, not recruiting
Liverpool Hospital
Liverpool, 2170
Active, not recruiting
Sir Charles Gairdner Hospital
Nedlands, 6009
Active, not recruiting
Calvary Mater Newcastle Hospital
New South Wales, 2298
Active, not recruiting
Wollongong Hospital
Wollongong, 2500
Active, not recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
Active, not recruiting

Other trials in Australia

Belgium7 sites

Institut Jules Bordet
Anderlecht, 1070
Active, not recruiting
ZAS Cadix
Antwerp, 2030
Active, not recruiting
ZAS Augustinus
Antwerp, 2610
Completed
Ghent University Hospital
Ghent, 9000
Active, not recruiting
Jolimont
Haine Saint Paul La Louviere, 7100
Completed
Az Groeninge
Kortrijk, 8500
Active, not recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
Active, not recruiting

Other trials in Belgium

Germany7 sites

Helios Kliniken Berlin Buch Gmbh
Berlin, 13125
Active, not recruiting
Med. Universitatsklinik Essen
Essen, 45147
Completed
Universitaetsklinikum Halle Saale
Halle, 06120
Active, not recruiting
Universitaetsklinik Hamburg-Eppendorf
Hamburg, 20251
Active, not recruiting
Klinikum Nuernberg Nord
Nuremberg, 90419
Active, not recruiting
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen, 72076
Active, not recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Active, not recruiting

Other trials in Germany

Czechia6 sites

Fakultni nemocnice Brno
Brno-Bohunice, 625 00
Active, not recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Active, not recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
Active, not recruiting
Fakultni Nemocnice Ostrava
Ostrava, 708 52
Active, not recruiting
Fakultni nemocnice Plzen
Pilsen, 304 60
Active, not recruiting
VFN v Praze
Prague, 128 08
Active, not recruiting

Other trials in Czechia

Israel6 sites

Soroka Medical Center
Beersheba, 8457108
Active, not recruiting
Rambam Medical Center
Haifa, 3109601
Active, not recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Active, not recruiting
Rabin
Petah Tikva, 49100
Active, not recruiting
Sheba Medical Center
Ramat Gan, 52621
Active, not recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Active, not recruiting

Other trials in Israel

Canada5 sites, 1 recruiting

Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Active, not recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Completed
Lakeridge Health Oshawa
Oshawa, Ontario, L1G-2B9
Recruiting
CHU de Quebec L Hotel Dieu de Quebec
Québec, Quebec, G1J 1Z4
Active, not recruiting
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z4E6
Active, not recruiting

Other trials in Canada

Netherlands5 sites

VUMC Amsterdam
Amsterdam, 1081 HV
Active, not recruiting
Gelre Ziekenhuis
Apeldoorn, 7334 DZ
Active, not recruiting
Reinier de Graaf Gasthuis
Delft, 2625 AD
Active, not recruiting
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM
Active, not recruiting
Zuyderland Medical Center
Sittard-Geleen, 6162 BG
Active, not recruiting

Other trials in Netherlands

Austria4 sites

Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Active, not recruiting
SCRI CCCIT gem GmbH
Salzburg, 5020
Active, not recruiting
Medical University Vienna
Vienna, 1090
Active, not recruiting
Hanusch Krankenhaus
Vienna, 1140
Active, not recruiting

Other trials in Austria

Denmark4 sites

Aalborg University Hospital
Aalborg, 9000
Active, not recruiting
Regionshospitalet Godstrup
Herning, 7400
Active, not recruiting
Zealand University Hospital
Køge, 4600
Active, not recruiting
Vejle Sygehus
Vejle, 7100
Active, not recruiting

Other trials in Denmark

Portugal4 sites

Uls Braga - Hosp. Braga
Braga, 4710-243
Active, not recruiting
Champalimaud Foundation Champalimaud Centre
Lisbon, 1400-038
Active, not recruiting
Uls Hosp Sao Joao
Porto, 4200 319
Active, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200072
Active, not recruiting

Other trials in Portugal

Sweden4 sites

Falu Lasarett
Falun, 791 82
Active, not recruiting
Skanes universitetssjukhus
Lund, 221 85
Active, not recruiting
Universitetssjukhuset Orebro
Örebro, 701 85
Active, not recruiting
Karolinska University Hospital Huddinge
Stockholm, 141 86
Active, not recruiting

Other trials in Sweden

Greece3 sites

Alexandra General Hospital of Athens
Athens Attica, 115 28
Active, not recruiting
Theageneio Cancer Hospital
Thessaloniki, 546 39
Active, not recruiting
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, 570 10
Active, not recruiting

Other trials in Greece

Norway2 sites

Oslo University Hospital HF Ulleval sykehus
Oslo, 0450
Active, not recruiting
St. Olavs Hospital
Trondheim, 7030
Active, not recruiting

Other trials in Norway

Switzerland2 sites

Inselspital Universitatsspital Bern
Bern, 3010
Active, not recruiting
Kantonsspital St Gallen
Sankt Gallen, 9007
Active, not recruiting

Other trials in Switzerland

About this study

Official title: 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

Conditions: Multiple Myeloma
Being tested: Teclistamab, Daratumumab, Lenalidomide, Dexamethasone, Talquetamab
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeclistamabDrug
Also called JNJ-64007957
Teclistamab will be administered as SC injection.
DaratumumabDrug
Daratumumab will be administered as SC injection.
LenalidomideDrug
Lenalidomide will be administered orally.
DexamethasoneDrug
Dexamethasone will be administered either orally or intravenously (IV).
TalquetamabDrug
Also called JNJ-64407564
Talquetamab will be administered as SC injection.

Study groups in NCT05552222
Study group	Role	What they receive
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)	Experimental	Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide. Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)	Experimental	Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Talquetamab
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)	Active comparator	Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone. Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At Month 12

Secondary outcomes (17)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From randomization up to 09 years
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Measured: 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.
Measured: 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.
Measured: From randomization up to 09 years
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.
Measured: 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.
Measured: 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).
Measured: From baseline up to 9 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.
Measured: From randomization up to 09 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 202228 Oct 2033

First posted23 Sep 2022
Study start25 Oct 2022
Primary completion30 Apr 2031 (estimated)
Study completion28 Oct 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,590 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05552222
Sponsor's protocol ID: CR109237
Other IDs: 64007957MMY3005, 2022-000909-28, 2023-503442-30-00, 2023
Acronym: MajesTEC-7
Status last verified: Nov 2026
First submitted: 21 Sep 2022
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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
Expanded access: Available

Interested in taking part?

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05552222
Acronym / sponsor ID: MajesTEC-7 / CR109237
Conditions: Multiple Myeloma
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,590 participants (estimated)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 25 Oct 2022 (actual)
Primary completion: 30 Apr 2031 (estimated)
Study completion: 28 Oct 2033 (estimated)
First posted: 23 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)	Experimental	Drug: Teclistamab, Drug: Daratumumab, Drug: LenalidomideParticipants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)	Experimental	Drug: Daratumumab, Drug: Lenalidomide, Drug: TalquetamabParticipants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)	Active comparator	Drug: Daratumumab, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TeclistamabAlso: JNJ-64007957Teclistamab will be administered as SC injection.	Drug	Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
DaratumumabDaratumumab will be administered as SC injection.	Drug	Daratumumab SC, Lenalidomide, and Dexamethasone (DRd), Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR), Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
LenalidomideLenalidomide will be administered orally.	Drug	Daratumumab SC, Lenalidomide, and Dexamethasone (DRd), Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR), Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
DexamethasoneDexamethasone will be administered either orally or intravenously (IV).	Drug	Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
TalquetamabAlso: JNJ-64407564Talquetamab will be administered as SC injection.	Drug	Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)

Primary outcome

Progression Free Survival (PFS)
Time frame: From randomization to the date of disease progression or death (Up to 09 years)
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.
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
Time frame: At Month 12
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.

17 secondary outcomes

Very Good Partial Response (VGPR) or Better
Time frame: From randomization up to 09 years
Complete Response (CR) or Better
Time frame: From randomization up to 09 years
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
Time frame: From randomization up to 09 years
MRD-negative CR
Time frame: From randomization up to 09 years
Progression Free Survival on Next-line Therapy (PFS2)
Time frame: From randomization up to 09 years
Overall Survival (OS)
Time frame: From randomization to the date of death (up to 09 years)
Number of Participants with Adverse Events (AEs) by Severity
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Vital Signs
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Physical Examination
Time frame: From randomization up to 09 years
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: From randomization up to 09 years
Serum Concentrations of Teclistamab and Talquetamab
Time frame: From randomization up to 09 years
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
Time frame: From randomization up to 09 years
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)
Time frame: 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)
Time frame: 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)
Time frame: From baseline up to 9 years
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
Time frame: From randomization up to 09 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Individual participant dataSharing planned: Yes. 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

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

270 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 270 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, China, Japan, Spain, Brazil and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization to the date of disease progression or death (Up to 09 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.