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)

August 27, 2026 updated by: Janssen Research & Development, LLC

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

838

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1114AAN
        • Fundaleu
      • CABA, Argentina, C1118AAT
        • Hospital Alemán
  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Box Hill, Australia, 3128
        • Box Hill Hospital
      • Darlinghurst, Australia, 2010
        • St Vincents Hospital
      • Fitzroy, Australia, 3065
        • St Vincents Hospital Melbourne
      • Southport, Australia, 4215
        • Gold Coast University Hospital
      • West Perth, Australia, 6005
        • Perth Blood Institute
      • Wollongong, Australia, 2500
        • Wollongong Hospital
  • Austria
      • Salzburg, Austria, 05020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Vienna, Austria, 1160
        • Klinik Ottakring
      • Vienna, Austria, A-1090
        • Medical University Vienna MUV
  • Belgium
      • Charleroi, Belgium, 6060
        • Grand Hopital De Charleroi Site Les Viviers
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
      • Ghent, Belgium, 9000
        • Ghent University Hospital
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • Brazil
      • Belo Horizonte, Brazil, 30110-022
        • Cetus Oncologia
      • Brasília, Brazil, 70390 700
        • IDOR - Regional Brasilia
      • Caxias do Sul, Brazil, 95070 560
        • Fundacao Universidade de Caxias do Sul
      • Curitiba, Brazil, 81520-060
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Recife, Brazil, 50070-480
        • IDOR - Regional Pernambuco
      • Rio de Janeiro, Brazil, 22793-080
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Brazil, 41253-190
        • IDOR - Regional Bahia
      • São José do Rio Preto, Brazil, 15090-000
        • Funfarme Sjrp
      • São Paulo, Brazil, 01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brazil, 04537 081
        • Clinica Medica Sao Germano LTDA
      • São Paulo, Brazil, 01323 001
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • São Paulo, Brazil, 01401 002
        • IDOR - Regional Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • British Columbia Cancer Agency
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • China
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100020
        • Beijing Chaoyang Hospital
      • Beijing, China, 101199
        • Peking University People's Hospital
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South Hospital
      • Changzhou, China, 213000
        • Changzhou No 2 Peoples Hospital
      • Chengdu, China, 610032
        • Sichuan Provincial Peoples Hospital
      • Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, China, 350001
        • Fujian Meidical University Union Hospital
      • Guangzhou, China, 510515
        • Nanfang Hospital of Southern Medical Hospital
      • Guangzhou, China, 510060
        • Sun Yat Sen University Cancer Center
      • Hangzhou, China, 310009
        • The Second Affiliated Hospital of Zhejiang University College of Medicine
      • Hangzhou, China, 310003
        • First hospital affiliated of Zhejiang Medical university
      • Hohhot, China, 010051
        • The Affiliated Hospital of Inner Mongolia Medical College
      • Jinan, China, 250012
        • Qilu Hospital of Shandong University
      • Nanchang, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanning, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai, China, 200025
        • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
      • Shanghai, China, 200065
        • Tongji Hospital of Tongji University
      • Shanghai, China, 200434
        • Shanghai Fourth People s Hospital
      • Shenyang, China, 110055
        • Shengjing Hospital of China Medical University
      • Shenzhen, China, 518036
        • Peking University Shenzhen Hospital
      • Taiyuan, China, 030032
        • Shanxi Bethune Hospital
      • Tianjin, China, 30060
        • Tianjin Medical University Cancer Institute and Hospital
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China, 430030
        • Tongji Hospital, Tongji Medical College of HUST
      • Xi'an, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xiamen, China, 361026
        • The First Affiliated Hospital of Xiamen University
  • Czechia
      • Brno-Bohunice, Czechia, 625 00
        • Fakultní Nemocnice Brno
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 779 00
        • University Hospital Olomouc
      • Ostrava, Czechia, 708 52
        • Fakultni nemocnice Ostrava
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Odense C, Denmark, 5000
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital
  • France
      • Lille, France, 59000
        • Hopital Claude Huriez
      • Limoges, France, 87042
        • CHU de Limoges Hopital Dupuytren
      • Lyon, France, 69002
        • Hospices Civils de Lyon HCL
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • CHU Nantes
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pessac, France, 33604
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Strasbourg, France, 67200
        • Institut de Cancerologie Strasbourg Europe ICANS
      • Toulouse, France, 31100
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours, France, 37044
        • CHRU Tours Hôpital Bretonneau
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Halle, Germany, 06120
        • Universitaetsklinikum Halle Saale
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg A.oe.R
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU Muenchen
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
      • Würzburg, Germany, 97080
        • Universitaetsklinikum Wuerzburg
  • Greece
      • Athens, Greece, 115 28
        • Alexandra General Hospital of Athens
      • Athens, Greece, 115 25
        • 251 Airforces Hospital
      • Thessaloniki, Greece, 546 39
        • Theageneio Cancer Hospital
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
      • Budapest, Hungary, 1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Nyíregyháza, Hungary, 4400
        • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
      • Pécs, Hungary, 7624
        • Pécsi Tudományegyetem Klinikai Központ
  • India
      • Gurgaon, India, 122002
        • Fortis Memorial Research Institute
      • Lucknow, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Pune, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
  • Israel
      • Be’er Ya‘aqov, Israel, 70300
        • Shamir Medical Center Assaf Harofeh
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical center - Petah-Tikva
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
      • Bologna, Italy, 40138
        • A O U Sant Orsola Malpighi
      • Brindisi, Italy, 72100
        • oncologia medica - Oncology
      • Catania, Italy, 95122
        • ARNAS Garibaldi P O Nesima
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Legnano, Italy, 20025
        • Asst Ovest Milanese - Ospedale Di Legnano
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pescara, Italy, 65124
        • Presidio Ospedaliero Pescara
      • Ravenna, Italy, 48121
        • Ospedale S. Maria delle Croci
      • Torino, Italy, 10126
        • Oncologia Medica-Città Della Salute E Della Scienza Di Torino
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Japan
      • Bunkyō City, Japan, 113 8431
        • Juntendo University Hospital
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Hamamatsu, Japan, 431 3192
        • Hamamatsu University Hospital
      • Kanazawa, Japan, 920 8641
        • Kanazawa University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Nagasaki, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center
      • Narita, Japan, 286-8523
        • Japanese Red Cross Narita Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Nishinomiya Shi, Japan, 663 8501
        • Hyogo Medical University Hospital
      • Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital
      • Sapporo, Japan, 060-8604
        • Sapporo City General Hospital
      • Sendai, Japan, 980 8574
        • Tohoku University Hospital
      • Shibuya-ku, Japan, 150-8935
        • Japanese Red Cross Medical Center
      • Shiwa-gun, Japan, 028-3695
        • Iwate Medical University Hospital
      • Suita, Japan, 565 0871
        • The University of Osaka Hospital
      • Sunto Gun, Japan, 411 8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 135 8550
        • The Cancer Institute Hospital of JFCR
      • Tottori, Japan, 683-0824
        • Tottori University Hospital
      • Tsukuba, Japan, 305 8576
        • University of Tsukuba Hospital
      • Yokohama, Japan, 241 8515
        • Kanagawa Cancer Center
  • Mexico
      • Guadalajara, Mexico, 45645
        • Centro de Quimioterapia e Investigacion
      • Huixquilucan, Mexico, 52787
        • Hematologica Alta Especialidad
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Netherlands
      • Almere Stad, Netherlands, 1315RA
        • Flevoziekenhuis
      • Eindhoven, Netherlands, 5623 EJ
        • Catharinaziekenhuis
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis Nieuwegein
      • The Hague, Netherlands, 2545 CH
        • Haga Ziekenhuis
      • Zwolle, Netherlands, 8025 AB
        • Isala Kliniek
  • Poland
      • Biała Podlaska, Poland, 21 500
        • Wojewodzki Szpital Specjalistyczny
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
      • Kielce, Poland, 25 734
        • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemii Lubelskiej
      • Szczecin, Poland, 71-252
        • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
      • Wroclaw, Poland, 50 367
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11564
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Saudi Arabia, 12231
        • King Fahad Medical City
      • Riyadh, Saudi Arabia, 11481
        • King Abdullah International Medical Research Center (KAIMRC)
  • South Korea
      • Busan, South Korea, 49201
        • Dong-A University Hospital
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Ulsan, South Korea, 44033
        • Ulsan University Hospital
  • Spain
      • Asturias, Spain, 33394
        • Hosp. de Cabuenes
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Burgos, Spain, 09003
        • Hosp. Univ. de Burgos
      • Cáceres, Spain, 10003
        • Hosp. San Pedro de Alcantara
      • Donostia / San Sebastian, Spain, 20014
        • Hosp. Univ. Donostia
      • Granada, Spain, 18014
        • Hosp. Univ. Virgen de Las Nieves
      • Lugo, Spain, 27003
        • Hosp. Univ. Lucus Augusti
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Palma de Mallorca, Spain, 07120
        • Hosp. Univ. Son Espases
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Pamplona, Spain, 31008
        • Complejo Hosp de Navarra - Hosp de Navarra
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Spain, 15706
        • Hosp. Clinico Univ. de Santiago
  • Sweden
      • Lund, Sweden, 221 85
        • Skånes universitetssjukhus
      • Umeå, Sweden, 901 85
        • Norrlands universitetssjukhus
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
      • Varberg, Sweden, 432 81
        • Varberg Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06680
        • Liv Hospital Ankara
      • Ankara, Turkey (Türkiye), 06620
        • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
      • Denizli, Turkey (Türkiye), 20070
        • Pamukkale Universitesi Tip Fakultesi
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol University Hospital
      • Samsun, Turkey (Türkiye), 55200
        • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Cardiff, United Kingdom, CF14 4HY
        • University Hospital of Wales
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • University Hospitals Plymouth NHS Trust
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
  • United States
    • California
      • Clovis, California, United States, 93611
        • UCSF Fresno
      • Santa Monica, California, United States, 90404
        • UCLA
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute Emory University
      • Newnan, Georgia, United States, 30265
        • City of Hope Cancer Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Iowa
      • Waukee, Iowa, United States, 50263
        • University of Iowa Health Care
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Our Lady of the Lake Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Center for Cancer and Blood Disorders
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
      • Baltimore, Maryland, United States, 21287
        • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Cancer Institute
      • Southfield, Michigan, United States, 48075
        • Henry Ford Health Providence Southfield Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • University of Nebraska
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes Cleveland VA Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Ctr
      • Philadelphia, Pennsylvania, United States, 19107 4215
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425-8900
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29607
        • Bon Secours Saint Francis Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • Dallas, Texas, United States, 75390
        • UT Southwestern Parkland Hospital
      • Houston, Texas, United States, 77030
        • Houston Methodist Neal Cancer Center at Texas Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Up to 3 years 5 months
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)
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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)
Time Frame: Up to 3 years 5 months
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)
Time Frame: Up to 3 years 5 months
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)
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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 Frame: Up to 3 years 5 months
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 Frame: Up to 3 years 5 months
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 Frame: Up to 3 years 5 months
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 Frame: Up to 3 years 5 months
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 Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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
Time Frame: Up to 3 years 5 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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