A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide (MonumenTAL-6)

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide; Drug: Teclistamab; Drug: Dexamethasone; Drug: Talquetamab; Drug: Elotuzumab; Drug: Bortezomib

• Study Type: Interventional
• Enrollment (Estimated): 795
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1114AAN
    • Active, not recruiting
    • Fundaleu
  • Buenos Aires, Argentina, C1280AEB
    • Completed
    • Hospital Britanico de Buenos Aires
  • CABA, Argentina, C1118AAT
    • Active, not recruiting
    • Hospital Aleman
• Australia
  • Adelaide, Australia, 5000
    • Active, not recruiting
    • Royal Adelaide Hospital
  • Box Hill, Australia, 3128
    • Active, not recruiting
    • Box Hill Hospital
  • Darlinghurst, Australia, 2010
    • Active, not recruiting
    • St Vincents Hospital
  • Fitzroy, Australia, 3065
    • Active, not recruiting
    • St Vincents Hospital Melbourne
  • Southport, Australia, 4215
    • Active, not recruiting
    • Gold Coast University Hospital
  • West Perth, Australia, 6005
    • Active, not recruiting
    • Perth Blood Institute
  • Wollongong, Australia, 2500
    • Active, not recruiting
    • Wollongong Hospital
• Austria
  • Salzburg, Austria, 05020
    • Active, not recruiting
    • LKH - Universitätsklinikum der PMU Salzburg
  • Vienna, Austria, A-1090
    • Completed
    • Medical University Vienna MUV
  • Vienna, Austria, 1160
    • Completed
    • Klinik Ottakring
• Belgium
  • Charleroi, Belgium, 6060
    • Active, not recruiting
    • Grand Hopital De Charleroi Site Les Viviers
  • Genk, Belgium, 3600
    • Active, not recruiting
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium, 9000
    • Active, not recruiting
    • Ghent University Hospital
  • Sint-Niklaas, Belgium, 9100
    • Active, not recruiting
    • AZ Nikolaas - Campus Sint-Niklaas Moerland
• Brazil
  • Belo Horizonte, Brazil, 30110-022
    • Active, not recruiting
    • Cetus Oncologia
  • Brasília, Brazil, 70390-140
    • Active, not recruiting
    • DF Star
  • Caxias do Sul, Brazil, 95070 560
    • Active, not recruiting
    • Fundacao Universidade de Caxias do Sul
  • Curitiba, Brazil, 81520-060
    • Active, not recruiting
    • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
  • Porto Alegre, Brazil, 90035-903
    • Completed
    • Hospital de Clinicas de Porto Alegre
  • Recife, Brazil, 50070-480
    • Active, not recruiting
    • Instituto D Or de Pesquisa e Ensino IDOR
  • Rio de Janeiro, Brazil, 22793-080
    • Active, not recruiting
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41253 190
    • Active, not recruiting
    • Hospital Sao Rafael
  • São José do Rio Preto, Brazil, 15090 000
    • Active, not recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • São Paulo, Brazil, 01509 900
    • Active, not recruiting
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01323 001
    • Active, not recruiting
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • São Paulo, Brazil, 04537-081
    • Active, not recruiting
    • Clinica Medica Sao Germano S/S LTDA
  • São Paulo, Brazil, 04543 000
    • Active, not recruiting
    • Instituto D Or de Pesquisa e Ensino
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Active, not recruiting
      • Arthur J E Child Comprehensive Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4E6
      • Active, not recruiting
      • British Columbia Cancer Agency
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Active, not recruiting
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8V5C2
      • Active, not recruiting
      • Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G2M9
      • Active, not recruiting
      • Princess Margaret Cancer Centre University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Active, not recruiting
      • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Active, not recruiting
      • Saskatoon Cancer Centre
• China
  • Beijing, China, 100034
    • Completed
    • Peking University First Hospital
  • Beijing, China, 100020
    • Active, not recruiting
    • Beijing Chaoyang Hospital
  • Beijing, China, 101199
    • Active, not recruiting
    • Peking University People's Hospital
  • Changsha, China, 410011
    • Active, not recruiting
    • The Second Xiangya Hospital of Central South Hospital
  • Changzhou, China, 213000
    • Active, not recruiting
    • Changzhou No 2 Peoples Hospital
  • Chengdu, China, 610032
    • Completed
    • Sichuan Provincial Peoples Hospital
  • Fuzhou, China, 350005
    • Completed
    • The First Affiliated Hospital of Fujian Medical University
  • Fuzhou, China, 350001
    • Completed
    • Fujian Meidical University Union Hospital
  • Guangzhou, China, 510060
    • Active, not recruiting
    • Sun Yat Sen University Cancer Center
  • Guangzhou, China, 510515
    • Completed
    • Nanfang Hospital of Southern Medical Hospital
  • Hangzhou, China, 310009
    • Completed
    • The Second Affiliated Hospital of Zhejiang University College of Medicine
  • Hangzhou, China, 310003
    • Active, not recruiting
    • First hospital affiliated of Zhejiang Medical university
  • Hohhot, China, 010051
    • Completed
    • The Affiliated Hospital of Inner Mongolia Medical College
  • Jinan, China, 250012
    • Completed
    • Qilu Hospital of Shandong University
  • Nanchang, China, 330006
    • Active, not recruiting
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210008
    • Active, not recruiting
    • Nanjing Drum Tower Hospital
  • Nanning, China, 530021
    • Completed
    • The First Affiliated Hospital of Guangxi Medical University
  • Shanghai, China, 200025
    • Active, not recruiting
    • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
  • Shanghai, China, 200434
    • Active, not recruiting
    • Shanghai Fourth People s Hospital
  • Shanghai, China, 200065
    • Completed
    • Tongji Hospital of Tongji University
  • Shenyang, China, 110055
    • Active, not recruiting
    • Shengjing hospital of China medical university
  • Shenzhen, China, 518036
    • Active, not recruiting
    • Peking University Shenzhen Hospital
  • Taiyuan, China, 030032
    • Completed
    • Shanxi Bethune Hospital
  • Tianjin, China, 30060
    • Active, not recruiting
    • Tianjin Medical University Cancer Institute and Hospital
  • Wenzhou, China, 325000
    • Active, not recruiting
    • The first Affiliated hospital of Wenzhou medical University
  • Wuhan, China, 430030
    • Active, not recruiting
    • Tongji Hospital, Tongji Medical College of HUST
  • Xi'an, China, 710004
    • Completed
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China, 361026
    • Completed
    • The First Affiliated Hospital of Xiamen University
• 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
    • University Hospital Olomouc
  • Ostrava, Czechia, 708 52
    • Active, not recruiting
    • Fakultni nemocnice Ostrava
• Denmark
  • Aarhus, Denmark, 8200
    • Completed
    • Aarhus University Hospital
  • Odense C, Denmark, 5000
    • Active, not recruiting
    • Odense University Hospital
  • Vejle, Denmark, 7100
    • Completed
    • Vejle Hospital
• France
  • Lille, France, 59000
    • Active, not recruiting
    • Hopital Claude Huriez
  • Limoges, France, 87042
    • Completed
    • CHU de Limoges Hopital Dupuytren
  • Lyon, France, 69002
    • Active, not recruiting
    • Hospices Civils de Lyon HCL
  • Marseille, France, 13009
    • Active, not recruiting
    • Institut Paoli Calmettes
  • Nantes, France, 44093
    • Active, not recruiting
    • Chu Nantes
  • Paris, France, 75010
    • Active, not recruiting
    • Hopital Saint Louis
  • Pessac, France, 33604
    • Active, not recruiting
    • CHU de Bordeaux - Hospital Haut-Leveque
  • Strasbourg, France, 67200
    • Completed
    • Institut de Cancerologie Strasbourg Europe ICANS
  • Toulouse, France, 31100
    • Active, not recruiting
    • Institut Universitaire du Cancer Toulouse Oncopole
  • Tours, France, 37044
    • Active, not recruiting
    • CHRU Tours Hopital Bretonneau
• Germany
  • Augsburg, Germany, 86156
    • Active, not recruiting
    • Klinikum Augsburg
  • Halle, Germany, 06120
    • Active, not recruiting
    • Universitaetsklinikum Halle Saale
  • Heidelberg, Germany, 69120
    • Active, not recruiting
    • Universitaetsklinikum Heidelberg
  • Magdeburg, Germany, 39120
    • Completed
    • Universitaetsklinikum Magdeburg A.oe.R
  • München, Germany, 81675
    • Completed
    • Klinikum rechts der Isar der TU Muenchen
  • Tübingen, Germany, 72076
    • Active, not recruiting
    • Universitaetsklinikum Tuebingen
  • Würzburg, Germany, 97080
    • Completed
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens, Greece, 115 25
    • Active, not recruiting
    • 251 Airforces Hospital
  • Athens, Greece, 115 28
    • Active, not recruiting
    • Alexandra General Hospital of Athens
  • Thessaloniki, Greece, 546 39
    • Active, not recruiting
    • Theageneio Cancer Hospital
• Hungary
  • Budapest, Hungary, 1088
    • Active, not recruiting
    • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
  • Budapest, Hungary, 1097
    • Completed
    • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
  • Debrecen, Hungary, 4032
    • Active, not recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Nyíregyháza, Hungary, 4400
    • Active, not recruiting
    • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
  • Pécs, Hungary, 7624
    • Active, not recruiting
    • Pecsi Tudomanyegyetem Klinikai Kozpont
• India
  • Gurgaon, India, 122002
    • Active, not recruiting
    • Fortis Memorial Research Institute
  • Lucknow, India, 226014
    • Completed
    • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Pune, India, 411004
    • Active, not recruiting
    • Deenanath Mangeshkar Hospital and Research Centre
• Israel
  • Be’er Ya‘aqov, Israel, 70300
    • Active, not recruiting
    • Shamir Medical Center Assaf Harofeh
  • Haifa, Israel, 3436212
    • Active, not recruiting
    • Carmel Medical Center
  • Petah Tikva, Israel, 49100
    • Active, not recruiting
    • Rabin Medical center - Petah-Tikva
  • Ramat Gan, Israel, 52621
    • Active, not recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Active, not recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Alessandria, Italy, 15121
    • Active, not recruiting
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
  • Bologna, Italy, 40138
    • Active, not recruiting
    • A O U Sant Orsola Malpighi
  • Brindisi, Italy, 72100
    • Active, not recruiting
    • oncologia medica - Oncology
  • Catania, Italy, 95122
    • Active, not recruiting
    • ARNAS Garibaldi P O Nesima
  • Genova, Italy, 16132
    • Active, not recruiting
    • Ospedale Policlinico San Martino IRCCS
  • Legnano, Italy, 20025
    • Active, not recruiting
    • Asst Ovest Milanese - Ospedale Di Legnano
  • Milan, Italy, 20132
    • Active, not recruiting
    • IRCCS Ospedale San Raffaele
  • Milan, Italy, 20122
    • Active, not recruiting
    • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
  • Pavia, Italy, 27100
    • Active, not recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Pescara, Italy, 65124
    • Active, not recruiting
    • Presidio Ospedaliero Pescara
  • Ravenna, Italy, 48121
    • Active, not recruiting
    • Ospedale S. Maria Delle Croci
  • Torino, Italy, 10126
    • Active, not recruiting
    • Oncologia Medica-Città Della Salute E Della Scienza Di Torino
  • Verona, Italy, 37134
    • Active, not recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
• Japan
  • Bunkyō City, Japan, 113 8431
    • Active, not recruiting
    • Juntendo University Hospital
  • Fukuoka, Japan, 814-0180
    • Active, not recruiting
    • Fukuoka University Hospital
  • Hamamatsu, Japan, 431 3192
    • Active, not recruiting
    • Hamamatsu University Hospital
  • Kanazawa, Japan, 920 8641
    • Completed
    • Kanazawa University Hospital
  • Kyoto, Japan, 602-8566
    • Active, not recruiting
    • University Hospital Kyoto Prefectural University of Medicine
  • Nagasaki, Japan, 856-8562
    • Completed
    • National Hospital Organization Nagasaki Medical Center
  • Narita, Japan, 286-8523
    • Active, not recruiting
    • Japanese Red Cross Narita Hospital
  • Niigata, Japan, 951-8566
    • Active, not recruiting
    • Niigata Cancer Center Hospital
  • Nishinomiya Shi, Japan, 663 8501
    • Active, not recruiting
    • Hyogo Medical University Hospital
  • Osaka, Japan, 543-8555
    • Active, not recruiting
    • Japanese Red Cross Osaka Hospital
  • Sapporo, Japan, 060-8604
    • Active, not recruiting
    • Sapporo City General Hospital
  • Sendai, Japan, 980 8574
    • Active, not recruiting
    • Tohoku University Hospital
  • Shibuya-ku, Japan, 150-8935
    • Active, not recruiting
    • Japanese Red Cross Medical Center
  • Shiwa-gun, Japan, 028-3695
    • Completed
    • Iwate Medical University Hospital
  • Suita, Japan, 565 0871
    • Completed
    • The University of Osaka Hospital
  • Sunto Gun, Japan, 411 8777
    • Active, not recruiting
    • Shizuoka Cancer Center
  • Tokyo, Japan, 135 8550
    • Active, not recruiting
    • The Cancer Institute Hospital of JFCR
  • Tottori, Japan, 683-0824
    • Active, not recruiting
    • Tottori University Hospital
  • Tsukuba, Japan, 305 8576
    • Active, not recruiting
    • University of Tsukuba Hospital
  • Yokohama, Japan, 241 8515
    • Active, not recruiting
    • Kanagawa Cancer Center
• Mexico
  • Guadalajara, Mexico, 45645
    • Active, not recruiting
    • Centro de Quimioterapia e Investigacion
  • Huixquilucan, Mexico, 52787
    • Active, not recruiting
    • Hematologica Alta Especialidad
  • Monterrey, Mexico, 64460
    • Active, not recruiting
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
• Netherlands
  • Almere Stad, Netherlands, 1315RA
    • Active, not recruiting
    • Flevoziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Active, not recruiting
    • Catharinaziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • Active, not recruiting
    • St. Antonius Ziekenhuis Nieuwegein
  • The Hague, Netherlands, 2545 CH
    • Active, not recruiting
    • Haga ziekenhuis
  • Zwolle, Netherlands, 8025 AB
    • Active, not recruiting
    • Isala Kliniek
• Poland
  • Biała Podlaska, Poland, 21 500
    • Active, not recruiting
    • Wojewodzki Szpital Specjalistyczny
  • Brzozów, Poland, 36-200
    • Active, not recruiting
    • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
  • Kielce, Poland, 25 734
    • Active, not recruiting
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lublin, Poland, 20-090
    • Active, not recruiting
    • Centrum Onkologii Ziemii Lubelskiej
  • Szczecin, Poland, 71-252
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
  • Wroclaw, Poland, 50 367
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11481
    • Completed
    • King Abdullah International Medical Research Center (KAIMRC)
  • Riyadh, Saudi Arabia, 11564
    • Active, not recruiting
    • King Faisal Specialist Hospital & Research Center
  • Riyadh, Saudi Arabia, 12231
    • Completed
    • King Fahad Medical City
• South Korea
  • Busan, South Korea, 49241
    • Active, not recruiting
    • Pusan National University Hospital
  • Busan, South Korea, 49201
    • Active, not recruiting
    • Dong-A University Hospital
  • Jeollanam-do, South Korea, 58128
    • Completed
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • Active, not recruiting
    • The Catholic University of Korea Seoul St Mary s Hospital
  • Ulsan, South Korea, 44033
    • Active, not recruiting
    • Ulsan University Hospital
• Spain
  • Asturias, Spain, 33394
    • Active, not recruiting
    • Hosp. de Cabuenes
  • Barcelona, Spain, 08035
    • Active, not recruiting
    • Hosp Univ Vall D Hebron
  • Burgos, Spain, 09003
    • Active, not recruiting
    • Hosp. Univ. de Burgos
  • Cáceres, Spain, 10003
    • Active, not recruiting
    • Hosp. San Pedro de Alcantara
  • Donostia / San Sebastian, Spain, 20014
    • Active, not recruiting
    • Hosp. Univ. Donostia
  • Granada, Spain, 18014
    • Active, not recruiting
    • Hosp. Univ. Virgen de Las Nieves
  • Lugo, Spain, 27003
    • Active, not recruiting
    • Hosp. Univ. Lucus Augusti
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Hosp. Univ. La Paz
  • Palma de Mallorca, Spain, 07120
    • Completed
    • Hosp. Univ. Son Espases
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Clinica Univ. de Navarra
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Complejo Hosp de Navarra - Hosp de Navarra
  • Salamanca, Spain, 37007
    • Completed
    • Hosp Clinico Univ de Salamanca
  • Santander, Spain, 39008
    • Active, not recruiting
    • Hosp. Univ. Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Active, not recruiting
    • Hosp. Clinico Univ. de Santiago
• Sweden
  • Lund, Sweden, 221 85
    • Active, not recruiting
    • Skånes universitetssjukhus
  • Umeå, Sweden, 901 85
    • Active, not recruiting
    • Norrlands Universitetssjukhus
  • Uppsala, Sweden, 75185
    • Active, not recruiting
    • Akademiska Sjukhuset
  • Varberg, Sweden, 432 81
    • Completed
    • Varberg Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06680
    • Active, not recruiting
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06620
    • Active, not recruiting
    • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
  • Denizli, Turkey (Türkiye), 20070
    • Active, not recruiting
    • Pamukkale Universitesi Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34214
    • Active, not recruiting
    • Medipol University Hospital
  • Samsun, Turkey (Türkiye), 55200
    • Active, not recruiting
    • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Completed
    • Blackpool Victoria Hospital
  • Cardiff, United Kingdom, CF14 4HY
    • Active, not recruiting
    • University Hospital of Wales
  • Dundee, United Kingdom, DD1 9SY
    • Active, not recruiting
    • Ninewells Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Active, not recruiting
    • St James University Hospital
  • London, United Kingdom, SE5 9RS
    • Active, not recruiting
    • Kings College Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Active, not recruiting
    • Nottingham City Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Active, not recruiting
    • University Hospitals Plymouth NHS Trust
  • Portsmouth, United Kingdom, PO6 3LY
    • Active, not recruiting
    • Queen Alexandra Hospital
• United States
  • California
    • Clovis, California, United States, 93611
      • Active, not recruiting
      • UCSF Fresno
    • Santa Monica, California, United States, 90404
      • Active, not recruiting
      • UCLA
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Active, not recruiting
      • Yale University School of Medicine
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Medical Oncology Hematology Consultants, PA
  • Florida
    • Hollywood, Florida, United States, 33021
      • Active, not recruiting
      • Memorial Healthcare System
    • Tampa, Florida, United States, 33612
      • Active, not recruiting
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Active, not recruiting
      • Winship Cancer Institute Emory University
    • Newnan, Georgia, United States, 30265
      • Recruiting
      • City of Hope Cancer Center
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Completed
      • Kootenai Health
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Active, not recruiting
      • Loyola University Medical Center
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Active, not recruiting
      • University of Iowa Health Care
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Active, not recruiting
      • Norton Cancer Institute
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Our Lady of the Lake Hospital
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Completed
      • Luminis Health Center for Cancer and Blood Disorders
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
    • Baltimore, Maryland, United States, 21287
      • Active, not recruiting
      • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Active, not recruiting
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Cancer Institute
    • Southfield, Michigan, United States, 48075
      • Active, not recruiting
      • Henry Ford Health Providence Southfield Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Active, not recruiting
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Active, not recruiting
      • Mayo Clinic Rochester
    • Saint Paul, Minnesota, United States, 55101
      • Completed
      • Regions Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Active, not recruiting
      • University of Nebraska
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Active, not recruiting
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Active, not recruiting
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Completed
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Medical University
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Active, not recruiting
      • Duke University Medical Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Completed
      • Gabrail Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Completed
      • Louis Stokes Cleveland VA Med Ctr
  • Oregon
    • Portland, Oregon, United States, 97239
      • Completed
      • Oregon Health and Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Active, not recruiting
      • Penn State Milton S Hershey Medical Ctr
    • Philadelphia, Pennsylvania, United States, 19107 4215
      • Active, not recruiting
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15224
      • Active, not recruiting
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • Completed
      • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8900
      • Recruiting
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29607
      • Active, not recruiting
      • Bon Secours Saint Francis Cancer Center
  • Texas
    • Dallas, Texas, United States, 75390
      • Active, not recruiting
      • UT Southwestern
    • Dallas, Texas, United States, 75390
      • Completed
      • UT Southwestern Parkland Hospital
    • Houston, Texas, United States, 77030
      • Completed
      • Houston Methodist Neal Cancer Center at Texas Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Active, not recruiting
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Active, not recruiting
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98109
      • Active, not recruiting
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98104
      • Completed
      • Swedish Cancer Institute
    • Tacoma, Washington, United States, 98405
      • Completed
      • NorthWest Medical Specialties, PLLC
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Gundersen Health System
    • Milwaukee, Wisconsin, United States, 53226
      • Active, not recruiting
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
• Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
• Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
• 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

Exclusion Criteria:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
• Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
• A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

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: Arm A: Talquetamab + Pomalidomide (Tal-P); Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Other Names: Pomalyst; Imnovid; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Talquetamab; Talquetamab will be administered as a SC injection.; Other Names: JNJ-64407564; Talvey
Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec); Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.	Drug: Teclistamab; Teclistamab will be administered as a SC injection.; Other Names: JNJ-64007957; Tecvayli; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Talquetamab; Talquetamab will be administered as a SC injection.; Other Names: JNJ-64407564; Talvey
Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd); Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.	Drug: Pomalidomide; Pomalidomide will be administered orally.; Other Names: Pomalyst; Imnovid; Drug: Dexamethasone; Dexamethasone will be administered either orally or intravenously.; Drug: Elotuzumab; Elotuzumab will be administered intravenously.; Other Names: Empliciti; Drug: Bortezomib; Bortezomib will be administered as a SC injection.; Other Names: Velcade

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.	Up to 3 years 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.	Up to 3 years 5 months
Complete Response (CR) or Better Rate	CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.	Up to 3 years 5 months
Very Good Partial Response (VGPR) or Better Rate	VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.	Up to 3 years 5 months
Minimal Residual Disease (MRD)-negative CR Rate	MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).	Up to 3 years 5 months
Overall Survival (OS)	OS is defined as the time from randomization to the date of participant's death.	Up to 3 years 5 months
Progression Free Survival on Next-line Therapy (PFS2)	PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.	Up to 3 years 5 months
Time to Next Treatment (TTNT)	TTNT is defined as the time from randomization to the start of SST.	Up to 3 years 5 months
Serum Concentration of Talquetamab and Teclistamab	Serum concentration of talquetamab and teclistamab will be reported.	Up to 3 years 5 months
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab	Number of participants with ADAs to talquetamab and teclistamab will be reported.	Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	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. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.	Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30	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. 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 or 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.	Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	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. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)	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. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."	Up to 3 years 5 months
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey	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. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.	Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q	Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.	Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30	Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. 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 or 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.	Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L	Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).	Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S	Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."	Up to 3 years 5 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey	Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.	Up to 3 years 5 months
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30	Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. 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 or 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 or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.	Up to 3 years 5 months
Number of Participants with Adverse Events (AEs) by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.	Up to 3 years 5 months

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): January 22, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 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; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; pomalidomide; elotuzumab; talquetamab
• Other Study ID Numbers: 64407564MMY3009 (Other Identifier: Janssen Research & Development, LLC); 2022-502446-27-00 (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 Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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