A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment (MonumenTAL-3)

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Talquetamab; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone

Detailed Description

Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

• Study Type: Interventional
• Enrollment (Actual): 864
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Edegem, Belgium, 2650
    • UZA
  • Hasselt, Belgium, 3500
    • Virga Jessa Ziekenhuis
  • Liège, Belgium, 4000
    • CHC MontLegia
  • Ottignies, Belgium, 1340
    • Clinique Saint Pierre
  • Yvoir, Belgium, 5530
    • UCL Mont Godinne
• Brazil
  • Barretos, Brazil, 14784 400
    • Fundacao Pio XII
  • Belo Horizonte, Brazil, 30150-221
    • Santa Casa de Misericordia de Belo Horizonte
  • Brasília, Brazil, 70390-140
    • Hospitais Integradaos da Gavea S/A - DF Star
  • Caxias do Sul, Brazil, 95070 560
    • Fundacao Universidade de Caxias do Sul
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Florianópolis, Brazil, 88034 000
    • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
  • Natal, Brazil, 59062-000
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Ribeirão Preto, Brazil, 14051 140
    • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
  • Rio de Janeiro, Brazil, 22775 001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • São Paulo, Brazil, 01321-001
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • São Paulo, Brazil, 01455 010
    • Clinica Sao Germano
  • São Paulo, Brazil, 01308 901
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01323-000
    • Hospital Paulistano
  • São Paulo, Brazil, 01401 002
    • Instituto D Or de Pesquisa e Ensino IDOR
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100006
    • Peking Union Medical College Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410000
    • The second Xiangya hospital of central south university
  • Chaoyang District, China, 100020
    • Beijing Chaoyang Hospital
  • Chengdu, China, 610072
    • Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510710
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310003
    • The First Affiliated Hospital Zhejiang University College of Medicine
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shanghai, China, 200065
    • Tongji Hospital of Tongji University
  • Shanghai, China, 200434
    • Shanghai Fourth People s Hospital
  • Shenzhen, China, 518036
    • Peking University Shenzhen Hospital
  • Suzhou, China, 215006
    • First Affiliated Hospital SooChow University
  • Tianjin, China, 300060
    • Tianjin cancer hospital
  • Tianjin, China, 300320
    • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
  • Wuhan, China, 430030
    • Tongji Hospital, Tongji Medical College of HUST
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
• France
  • Créteil, France, 94010
    • APHP - Hopital Henri Mondor
  • Dijon, France, 21000
    • CHU Dijon
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Saint-Eloi
  • Nantes, France, 44093
    • CHU de Nantes hotel Dieu
  • Nice, France, 06202
    • CHU HOPITAL DE L'ARCHET - Hematology
  • Paris, France, 75571
    • CHU Hopital Saint Antoine
  • Pessac, France, 33604
    • CHRU - Hôpital du Haut Lévêque - Centre François Magendie
  • Toulouse, France, 31059
    • Institut Universitaire du cancer de Toulouse-Oncopole
• Germany
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin
  • Cologne, Germany, 50937
    • Universitaetsklinikum Koeln
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg Universität
  • Würzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens Attica, Greece, 115 28
    • Alexandra General Hospital of Athens
  • Thessaloniki, Greece, 546 39
    • Anticancer Hospital of Thessaloniki Theageneio
  • Thessalonikis, Greece, 570 10
    • G Papanikolaou Hospital of Thessaloniki
• Israel
  • Afula, Israel, 1834111
    • Ha'Emek Medical Center
  • Be’er Ya‘aqov, Israel, 70300
    • Shamir Medical Center Assaf Harofeh
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Haifa, Israel, 34362
    • Carmel Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Nahariya, Israel, 22100
    • Galilee Medical Center
  • Petah Tikva, Israel, 49100
    • Beilinson medical center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 6423906
    • Sourasky (Ichilov) Medical Center
• Italy
  • Ancona, Italy, 60126
    • A.O. Universitaria Ospedali Riuniti di Ancona
  • Bari, Italy, 70124
    • Policlinico di Bari
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Catania, Italy, 95123
    • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Padova, Italy, 35128
    • Azienda Ospedaliera Universitaria Di Padova
  • Palermo, Italy, 90146
    • Ospedale Villa Sofia-Cervello
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova - IRCCS
  • Roma, Italy, 00193
    • Presidio Ospedaliero Santo Spirito in Sassia
  • San Giovanni Rotondo, Italy, 71013
    • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Torino, Italy, 10126
    • A.O.U. Città della Salute e della Scienza
• Japan
  • Bunkyō City, Japan, 113 8519
    • Institute of Science Tokyo Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Gifu, Japan, 503-8502
    • Ogaki Municipal Hospital
  • Gunma, Japan, 371-0034
    • Gunma University Hospital
  • Hirakata, Japan, 573 1191
    • Kansai Medical University Hospital
  • Hyōgo, Japan, 670-8540
    • Japanese Red Cross Society Himeji Hospital
  • Kamakura-shi, Japan, 247-8533
    • Shonan Kamakura General Hospital
  • Kashiwa, Japan, 277 8577
    • National Cancer Center Hospital East
  • Koshigaya, Japan, 343-8555
    • Dokkyo Medical University Saitama Medical Center
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 603-8151
    • Kyoto Kuramaguchi Medical Center
  • Matsumoto, Japan, 399-8701
    • National Hospital Organization Matsumoto Medical Center
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Nishinomiya Shi, Japan, 663 8501
    • Hyogo Medical University Hospital
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shiwa-gun, Japan, 028-3695
    • Iwate Medical University Hospital
  • Suita, Japan, 565 0871
    • The University of Osaka Hospital
  • Tokyo, Japan, 135 8550
    • The Cancer Institute Hospital of JFCR
  • Ōtake, Japan, 739-0696
    • National Hospital Organization Hiroshima-Nishi Medical Center
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer ziekenhuis-lokatie Dordwijk
  • Eindhoven, Netherlands, 5631 BM
    • Maxima Medisch Centrum
  • Rotterdam, Netherlands, 3015
    • Erasmus MC
• Poland
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40 519
    • Pratia Onkologia Katowice
  • Kielce, Poland, 25 734
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Krakow, Poland, 30 688
    • Szpital Uniwersytecki w Krakowie
  • Lublin, Poland, 20090
    • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
  • Olsztyn, Poland, 10-228
    • Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
  • Szczecin, Poland, 71-252
    • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
  • Torun, Poland, 87 100
    • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 50 367
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• South Korea
  • Busan, South Korea, 602 812
    • Dong-A University Hospital
  • Gyeonggi-do, South Korea, 10408
    • National Cancer Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Jeonju, South Korea, 54907
    • Jeonbuk National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
• Spain
  • Badalona, Spain, 08916
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hosp Univ Vall D Hebron
  • El Palmar, Spain, 30120
    • Hosp. Univ. Virgen de La Arrixaca
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • León, Spain, 24071
    • Hosp. de Leon
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28050
    • Hosp Univ Hm Sanchinarro
  • Málaga, Spain, 29010
    • Hosp Virgen de La Victoria
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Hosp Clinico Univ de Salamanca
  • San Cristóbal de La Laguna, Spain, 38320
    • Hosp. Univ. de Canarias
  • Valencia, Spain, 46017
    • Hosp. Univ. Dr. Peset
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
  • Ankara, Turkey (Türkiye), 06590
    • Ankara University Medical Faculty
  • Antalya, Turkey (Türkiye), 07100
    • Antalya Egitim ve Arastirma Hastanesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul University Istanbul Medical Faculty
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol Mega University Hospital
  • Istanbul, Turkey (Türkiye), 34153
    • Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi
  • Izmir, Turkey (Türkiye), 35330
    • Dokuz Eylul University Medical Faculty
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis University
• United Kingdom
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Victoria Hospital
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Newcastle Freeman Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • University Hospitals Plymouth NHS Trust
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Norwalk Hospital-oncology
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington University
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Miami, Florida, United States, 33136
      • University of Miami Health System
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital & Clinics
    • New Orleans, Louisiana, United States, 70121-2429
      • Ochsner Health System
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63110-1032
      • Washington University School of Medicine
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute, Carolinas HealthCare System
    • Charlotte, North Carolina, United States, 28204
      • Novant Health 1
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43214
      • OhioHealth
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center - James Cancer Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-4215
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8900
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research Treatment Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University - Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
• Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
• Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
• Documented evidence of progressive disease based on investigator's determination of response by the 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

Exclusion Criteria:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
• Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
• Received prior pomalidomide therapy
• A maximum cumulative dose of corticosteroids to >=140 milligrams (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
• Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

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 Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP); Participants will receive talquetamab and daratumumab as 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: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Daratumumab; Daratumumab will be administered subcutaneously.; Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.
Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd); Participants will receive daratumumab as SC injection; 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: Daratumumab; Daratumumab will be administered subcutaneously.; Drug: Pomalidomide; Pomalidomide will be administered orally.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.
Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D); Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.	Drug: Talquetamab; Talquetamab will be administered subcutaneously.; Other Names: JNJ-64407564; Drug: Daratumumab; Daratumumab will be administered subcutaneously.; Drug: Dexamethasone; Dexamethasone will be administered orally or intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.	Up to 6 years 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response (Partial Response [PR] or Better)	Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.	Up to 6 years 6 months
Very Good Partial Response (VGPR) or Better Rate	VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.	Up to 6 years 6 months
Complete Response (CR) or Better Rate	CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.	Up to 6 years 6 months
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 6 years 6 months
Number of Participants with AEs by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	Up to 6 years 6 months
Serum Concentrations of Talquetamab	Serum concentrations of talquetamab will be reported.	Up to 6 years 6 months
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab	Number of participants with presence ADAs to talquetamab will be reported.	Up to 6 years 6 months
Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab	Number of participants with presence of ADAs to daratumumab will be reported.	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c	The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE	The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.	Up to 6 years 6 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)	The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.	Up to 6 years 6 months
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.	Baseline up to 6 years 6 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c	The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.	Baseline up to 6 years 6 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.	Baseline up to 6 years 6 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE	The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.	Baseline up to 6 years 6 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.	Baseline up to 6 years 6 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)	The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.	Baseline up to 6 years 6 months
Overall Minimal Residual Disease (MRD) Negative CR	MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.	Up to 6 years 6 months
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of the participant's death.	Up to 6 years 6 months
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 on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.	Up to 6 years 6 months
Time to Next Therapy (TTNT)	TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.	Up to 6 years 6 months
Serum Concentrations of Daratumumab	Serum concentrations of daratumumab will be reported.	Up to 6 years 6 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Click here to learn more about the 64407564MMY3002 (MonumenTAL-3) trial

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): May 25, 2028

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; pomalidomide; daratumumab; talquetamab
• Other Study ID Numbers: CR109082; 2021-000202-22 (EudraCT Number); 64407564MMY3002 (Other Identifier: Janssen Research & Development, LLC); 2021-000202-22-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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