AzTrials
AzTrials

Multiple MyelomaPhase 3MonumenTAL-3NCT05455320

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

A Phase 3 study testing Talquetamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 216 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Talquetamab, Daratumumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
864 participants
Where
216 sitesin 18 countries
Study dates
13 Oct 2022to 25 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

216 sites in 18 countries.

216 sites in 18 countries

United States40 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Massachusetts General

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204

  • Novant Health 1

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University Of Illinois

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Ohio State University Wexner Medical Center - James Cancer Hospital

    Columbus, Ohio, 43210

  • OhioHealth

    Columbus, Ohio, 43214

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Joe Arrington Cancer Research Treatment Center

    Lubbock, Texas, 79410

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • University of Miami Health System

    Miami, Florida, 33136

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Tulane University Hospital & Clinics

    New Orleans, Louisiana, 70112

  • Ochsner Health System

    New Orleans, Louisiana, 70121-2429

  • NYU Langone Health

    New York, New York, 10016

  • Norwalk Hospital-oncology

    Norwalk, Connecticut, 06850

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-4215

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • University of Kansas

    Westwood, Kansas, 66205

  • Novant Health

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Japan21 sites

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

  • Chiba Cancer Center

    Chiba, 260-8717

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Ogaki Municipal Hospital

    Gifu, 503-8502

  • Gunma University Hospital

    Gunma, 371-0034

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Japanese Red Cross Society Himeji Hospital

    Hyōgo, 670-8540

  • Shonan Kamakura General Hospital

    Kamakura-shi, 247-8533

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Ōtake, 739-0696

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980 8574

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

  • The University of Osaka Hospital

    Suita, 565 0871

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

Other trials in Japan

China19 sites

  • Peking Union Medical College Hospital

    Beijing, 100006

  • Peking University First Hospital

    Beijing, 100034

  • The First Hospital of Jilin University

    Changchun, 130021

  • The second Xiangya Hospital of Central South University

    Changsha, 410000

  • Beijing Chaoyang Hospital

    Chaoyang District, 100020

  • Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510710

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Tongji Hospital of Tongji University

    Shanghai, 200065

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • First Affiliated Hospital SooChow University

    Suzhou, 215006

  • Tianjin cancer hospital

    Tianjin, 300060

  • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

    Tianjin, 300320

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Brazil17 sites

  • Fundacao Pio XII

    Barretos, 14784 400

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • IDOR - Regional Brasilia

    Brasília, 70390-140

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, 88020 210

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14051140

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01321-001

  • Hospital Paulistano

    São Paulo, 01323-000

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

Other trials in Brazil

Spain16 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hosp. Univ. Virgen de La Arrixaca

    El Palmar, 30120

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. de Leon

    León, 24071

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

Other trials in Spain

Italy14 sites

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

    Catania, 95123

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123

  • Presidio Ospedaliero Santo Spirito in Sassia

    Roma, 00193

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126

Other trials in Italy

Israel12 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Galilee Medical Center

    Nahariya, 22100

  • Beilinson medical center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Ziv Medical Center

    Safed, 13100

  • Sourasky (Ichilov) Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Poland11 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozów, 36-200

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Pratia Onkologia Katowice

    Katowice, 40 519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Szpital Uniwersytecki w Krakowie

    Krakow, 30 688

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20090

  • Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii

    Olsztyn, 10-228

  • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie

    Szczecin, 71-252

  • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

    Torun, 87 100

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

South Korea10 sites

  • Dong-A University Hospital

    Busan, 602 812

  • National Cancer Center

    Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

France9 sites

  • APHP - Hopital Henri Mondor

    Créteil, 94010

  • CHU Dijon

    Dijon, 21000

  • Centre Leon Berard

    Lyon, 69008

  • CHU de Montpellier - Hopital Saint-Eloi

    Montpellier, 34295

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • CHU HOPITAL DE L'ARCHET - Hematology

    Nice, 06202

  • CHU Hopital Saint Antoine

    Paris, 75571

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie

    Pessac, 33604

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059

Other trials in France

Turkey (Türkiye)9 sites

  • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit

    Ankara, 06200

  • Ankara University Medical Faculty

    Ankara, 06590

  • Liv Hospital Ankara

    Ankara, 06680

  • Antalya Egitim ve Arastirma Hastanesi

    Antalya, 07100

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi

    Istanbul, 34153

  • Medipol Mega University Hospital

    Istanbul, 34214

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

  • Ondokuz Mayis University

    Samsun, 55139

Other trials in Turkey (Türkiye)

United Kingdom8 sites

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Hammersmith Hospital

    London, W12 0HS

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

  • Royal Marsden Hospital

    Sutton, SM2 5PT

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany7 sites

  • Charite Campus Benjamin Franklin

    Berlin, 12203

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitätsmedizin der Johannes Gutenberg Universität

    Mainz, 55131

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Belgium6 sites

  • UZ Brussel

    Brussels, 1090

  • UZA

    Edegem, 2650

  • Virga Jessa Ziekenhuis

    Hasselt, 3500

  • CHC MontLegia

    Liège, 4000

  • Clinique Saint Pierre

    Ottignies, 1340

  • UCL Mont Godinne

    Yvoir, 5530

Other trials in Belgium

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

    Prague, 128 08

Other trials in Czechia

Taiwan5 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10048

Other trials in Taiwan

Greece3 sites

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39

  • G Papanikolaou Hospital of Thessaloniki

    Thessalonikis, 570 10

Other trials in Greece

Netherlands3 sites

  • Albert Schweitzer ziekenhuis-lokatie Dordwijk

    Dordrecht, 3318 AT

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM

  • Erasmus MC

    Rotterdam, 3015

Other trials in Netherlands

About this study

Official title: 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).

Being tested
Talquetamab, Daratumumab, Pomalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered subcutaneously.

  • DaratumumabDrug

    Daratumumab will be administered subcutaneously.

  • PomalidomideDrug

    Pomalidomide will be administered orally.

  • DexamethasoneDrug

    Dexamethasone will be administered orally or intravenously.

Study groups in NCT05455320
Study groupRoleWhat they receive
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)ExperimentalParticipants 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. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug Access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.
Receives: Drug: Talquetamab; Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)ExperimentalParticipants 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. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Dexamethasone
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)ExperimentalParticipants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.
Receives: Drug: Talquetamab; Drug: Daratumumab; Drug: Dexamethasone

What is being measured

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

  1. 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.

    Measured: Up to 6 years 6 months

Secondary outcomes (25)

  1. 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.

    Measured: Up to 6 years 6 months

  2. 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.

    Measured: Up to 6 years 6 months

  3. 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.

    Measured: Up to 6 years 6 months

  4. 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.

    Measured: Up to 6 years 6 months

  5. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of the participant's death.

    Measured: Up to 6 years 6 months

  6. 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.

    Measured: Up to 6 years 6 months

  7. Time to Next Therapy (TTNT)

    TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.

    Measured: Up to 6 years 6 months

  8. 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.

    Measured: Up to 6 years 6 months

  9. 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).

    Measured: Up to 6 years 6 months

  10. Serum Concentrations of Talquetamab

    Serum concentrations of talquetamab will be reported.

    Measured: Up to 6 years 6 months

  11. Serum Concentrations of Daratumumab

    Serum concentrations of daratumumab will be reported.

    Measured: Up to 6 years 6 months

  12. Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab

    Number of participants with presence ADAs to talquetamab will be reported.

    Measured: Up to 6 years 6 months

  13. Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab

    Number of participants with presence of ADAs to daratumumab will be reported.

    Measured: Up to 6 years 6 months

  14. 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).

    Measured: Up to 6 years 6 months

  15. 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.

    Measured: Up to 6 years 6 months

  16. 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.

    Measured: Up to 6 years 6 months

  17. 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.

    Measured: Up to 6 years 6 months

  18. 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.

    Measured: Up to 6 years 6 months

  19. 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.

    Measured: Up to 6 years 6 months

  20. 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.

    Measured: Baseline up to 6 years 6 months

  21. 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.

    Measured: Baseline up to 6 years 6 months

  22. 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.

    Measured: Baseline up to 6 years 6 months

  23. 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.

    Measured: Baseline up to 6 years 6 months

  24. 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.

    Measured: Baseline up to 6 years 6 months

  25. 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.

    Measured: Baseline up to 6 years 6 months

Timeline

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

  1. First posted13 Jul 2022
  2. Study start13 Oct 2022
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
864 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455320
Sponsor's protocol ID
CR109082
Other IDs
64407564MMY3002, 2021-000202-22, 2023-503467-41-00, 2023
Acronym
MonumenTAL-3
Status last verified
Nov 2026
First submitted
22 Jun 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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
Expanded access
Available

Publications

  • Mina R, Beksac M, Rodriguez-Otero P, Chen W, Mateos MV, Li J, Moreau P, Cohen YC, Min CK, Jelinek T, Ye JC, Magen H, Rubinstein SM, Fu W, Hungria V, Cengiz Seval G, Farias JS, Radocha J, Maral S, Turgut M, Koh Y, O'Leary D, Schmidt Filho J, Thertulien R, An G, Huang SY, Grosicki S, Tyczynska A, Banerjee R, Pianko MJ, Martinez-Lopez J, Steckiewicz P, Maruyama D, Fukushima K, Oriol A, Lopez Pardo J, Goldschmidt H, Pawlyn C, Perrot A, Zamagni E, Dimopoulos MA, Rasche L, Tolbert J, Terry W, Courtoux C, Liu X, Vasey SY, Connors K, Festa M, Heuck C, Langlois A, O'Rourke L, Zhou J, Qin X, Lu J, Gong J, Vieyra D, Voorhees PM; MonumenTAL-3 Investigators. Talquetamab-Daratumumab in Relapsed or Refractory Myeloma. N Engl J Med. 2026 Jun 13. doi: 10.1056/NEJMoa2604657. Online ahead of print.

    PubMed 42294841

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Talquetamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 216 sites in 18 countries.

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

Who may be eligible to take part?

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

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Japan, China, Brazil, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Up to 6 years 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455320, which also lists 1 linked publication.

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

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

How often is this information updated?

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

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