AzTrials
AzTrials

Multiple MyelomaPhase 3MonumenTAL-6NCT06208150

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

A Phase 3 study testing Talquetamab, Pomalidomide and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 242 sites in 27 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 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). 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, Pomalidomide and Teclistamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
838 participants
Where
242 sitesin 27 countries
Study dates
22 Jan 2024to 31 Mar 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 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

Who cannot join

  • 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

Trial locations and contacts

242 sites in 27 countries.

242 sites in 27 countries

United States49 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Luminis Health Center for Cancer and Blood Disorders

    Annapolis, Maryland, 21401

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21287

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana, 70808

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-8900

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Louis Stokes Cleveland VA Med Ctr

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UCSF Fresno

    Clovis, California, 93611

  • Kootenai Health

    Coeur d'Alene, Idaho, 83814

  • UT Southwestern Parkland Hospital

    Dallas, Texas, 75390

  • UT Southwestern

    Dallas, Texas, 75390

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Bon Secours Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S Hershey Medical Ctr

    Hershey, Pennsylvania, 17033

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Houston Methodist Neal Cancer Center at Texas Medical Center

    Houston, Texas, 77030

  • Gundersen Health System

    La Crosse, Wisconsin, 54601

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

  • Weill Cornell Medical College

    New York, New York, 10065

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware, 19713

  • City of Hope Cancer Center

    Newnan, Georgia, 30265

  • University of Nebraska

    Omaha, Nebraska, 68105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107 4215

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health And Science University

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • UCLA

    Santa Monica, California, 90404

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Henry Ford Health Providence Southfield Hospital

    Southfield, Michigan, 48075

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • NorthWest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Iowa Health Care

    Waukee, Iowa, 50263

Other trials in United States

China28 sites

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 101199

  • The Second Xiangya Hospital of Central South Hospital

    Changsha, 410011

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213000

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610032

  • Fujian Meidical University Union Hospital

    Fuzhou, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515

  • First hospital affiliated of Zhejiang Medical university

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • The Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, 010051

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

  • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

    Shanghai, 200025

  • Tongji Hospital of Tongji University

    Shanghai, 200065

  • Shanghai Fourth People s Hospital

    Shanghai, 200434

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • Shanxi Bethune Hospital

    Taiyuan, 030032

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 30060

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004

  • The first affiliated hospital of xiamen university

    Xiamen, 361026

Other trials in China

Japan20 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Hamamatsu University Hospital

    Hamamatsu, 431 3192

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • National Hospital Organization Nagasaki Medical Center

    Nagasaki, 856-8562

  • Japanese Red Cross Narita Hospital

    Narita, 286-8523

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555

  • Sapporo City General Hospital

    Sapporo, 060-8604

  • Tohoku University Hospital

    Sendai, 980 8574

  • Japanese Red Cross Medical Center

    Shibuya-ku, 150-8935

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

  • The University of Osaka Hospital

    Suita, 565 0871

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Tottori University Hospital

    Tottori, 683-0824

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

  • Kanagawa Cancer Center

    Yokohama, 241 8515

Other trials in Japan

Spain14 sites

  • Hosp. de Cabuenes

    Asturias, 33394

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. de Burgos

    Burgos, 09003

  • Hosp. San Pedro de Alcantara

    Cáceres, 10003

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20014

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Complejo Hosp de Navarra - Hosp de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Brazil13 sites

  • Cetus Oncologia

    Belo Horizonte, 30110-022

  • IDOR - Regional Brasilia

    Brasília, 70390 700

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560

  • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

    Curitiba, 81520-060

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035-903

  • IDOR - Regional Pernambuco

    Recife, 50070-480

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

    Rio de Janeiro, 22793-080

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 001

  • 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

Italy13 sites

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

    Alessandria, 15121

  • A O U Sant Orsola Malpighi

    Bologna, 40138

  • Ospedale Perrino

    Brindisi, 72100

  • ARNAS Garibaldi P O Nesima

    Catania, 95122

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Asst Ovest Milanese - Ospedale Di Legnano

    Legnano, 20025

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Presidio Ospedaliero Pescara

    Pescara, 65124

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Oncologia Medica-Città Della Salute E Della Scienza Di Torino

    Torino, 10126

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37134

Other trials in Italy

France10 sites

  • Hopital Claude Huriez

    Lille, 59000

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87042

  • Hospices Civils de Lyon HCL

    Lyon, 69002

  • Institut Paoli Calmettes

    Marseille, 13009

  • CHU Nantes

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75010

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100

  • CHRU Tours Hopital Bretonneau

    Tours, 37044

Other trials in France

United Kingdom8 sites

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • University Hospital of Wales

    Cardiff, CF14 4HY

  • Ninewells Hospital

    Dundee, DD1 9SY

  • St James University Hospital

    Leeds, LS9 7TF

  • Kings College Hospital

    London, SE5 9RS

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Box Hill Hospital

    Box Hill, 3128

  • St Vincents Hospital

    Darlinghurst, 2010

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Gold Coast University Hospital

    Southport, 4215

  • Perth Blood Institute

    West Perth, 6005

  • Wollongong Hospital

    Wollongong, 2500

Other trials in Australia

Canada7 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z4E6

Other trials in Canada

Germany7 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Universitaetsklinikum Halle Saale

    Halle, 06120

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, 39120

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

South Korea7 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Poland6 sites

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500

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

    Brzozów, 36-200

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Centrum Onkologii Ziemii Lubelskiej

    Lublin, 20-090

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

    Szczecin, 71-252

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

Hungary5 sites

  • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

Other trials in Hungary

Israel5 sites

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

  • Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical center - Petah-Tikva

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Netherlands5 sites

  • Flevoziekenhuis

    Almere Stad, 1315RA

  • Catharinaziekenhuis

    Eindhoven, 5623 EJ

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

  • Haga ziekenhuis

    The Hague, 2545 CH

  • Isala Kliniek

    Zwolle, 8025 AB

Other trials in Netherlands

Turkey (Türkiye)5 sites

  • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

    Ankara, 06620

  • Liv Hospital Ankara

    Ankara, 06680

  • Pamukkale Universitesi Tip Fakultesi

    Denizli, 20070

  • Medipol University Hospital

    Istanbul, 34214

  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55200

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Grand Hopital De Charleroi Site Les Viviers

    Charleroi, 6060

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Ghent University Hospital

    Ghent, 9000

  • AZ Nikolaas - Campus Sint-Niklaas Moerland

    Sint-Niklaas, 9100

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno-Bohunice, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

Other trials in Czechia

Sweden4 sites

  • Skanes universitetssjukhus

    Lund, 221 85

  • Norrlands Universitetssjukhus

    Umeå, 901 85

  • Akademiska Sjukhuset

    Uppsala, 75185

  • Varberg Hospital

    Varberg, 432 81

Other trials in Sweden

Argentina3 sites

  • Fundaleu

    Buenos Aires, C1114AAN

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

  • Hospital Aleman

    CABA, C1118AAT

Other trials in Argentina

Austria3 sites

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 05020

  • Klinik Ottakring

    Vienna, 1160

  • Medical University Vienna MUV

    Vienna, A-1090

Other trials in Austria

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8200

  • Odense University Hospital

    Odense C, 5000

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

Greece3 sites

  • 251 Airforces Hospital

    Athens, 115 25

  • Alexandra General Hospital of Athens

    Athens, 115 28

  • Theageneio Cancer Hospital

    Thessaloniki, 546 39

Other trials in Greece

India3 sites

  • Fortis Memorial Research Institute

    Gūrgaon, 122002

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, 226014

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

Other trials in India

Mexico3 sites

  • Centro de Quimioterapia e Investigacion

    Guadalajara, 45645

  • Hematologica Alta Especialidad

    Huixquilucan, 52787

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Saudi Arabia3 sites

  • King Abdullah International Medical Research Center (KAIMRC)

    Riyadh, 11481

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11564

  • King Fahad Medical City

    Riyadh, 12231

Other trials in Saudi Arabia

About this study

Official title: 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).

Being tested
Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, 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, Talvey

    Talquetamab will be administered as a SC injection.

  • PomalidomideDrug

    Also called Pomalyst, Imnovid

    Pomalidomide will be administered orally.

  • TeclistamabDrug

    Also called JNJ-64007957, Tecvayli

    Teclistamab will be administered as a SC injection.

  • ElotuzumabDrug

    Also called Empliciti

    Elotuzumab will be administered intravenously.

  • DexamethasoneDrug

    Dexamethasone will be administered either orally or intravenously.

  • BortezomibDrug

    Also called Velcade

    Bortezomib will be administered as a SC injection.

Study groups in NCT06208150
Study groupRoleWhat they receive
Arm A: Talquetamab + Pomalidomide (Tal-P)ExperimentalParticipants 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.
Receives: Drug: Talquetamab; Drug: Pomalidomide; Drug: Dexamethasone
Arm B: Talquetamab + Teclistamab (Tal-Tec)ExperimentalParticipants 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.
Receives: Drug: Talquetamab; Drug: Teclistamab; Drug: Dexamethasone
Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)Active comparatorParticipants 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.
Receives: Drug: Pomalidomide; Drug: Elotuzumab; Drug: Dexamethasone; Drug: Bortezomib

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 the duration from the date of randomization to either progressive disease or death, whichever comes first.

    Measured: Up to 3 years 5 months

Secondary outcomes (21)

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria.

    Measured: Up to 3 years 5 months

  2. Complete Response (CR) or Better Rate

    CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.

    Measured: Up to 3 years 5 months

  3. Very Good Partial Response (VGPR) or Better Rate

    VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.

    Measured: Up to 3 years 5 months

  4. Minimal Residual Disease (MRD)-negative CR Rate

    MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST).

    Measured: Up to 3 years 5 months

  5. Overall Survival (OS)

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

    Measured: Up to 3 years 5 months

  6. Progression Free Survival on Next-line Therapy (PFS2)

    PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.

    Measured: Up to 3 years 5 months

  7. Time to Next Treatment (TTNT)

    TTNT is defined as the time from randomization to the start of SST.

    Measured: Up to 3 years 5 months

  8. Serum Concentration of Talquetamab and Teclistamab

    Serum concentration of talquetamab and teclistamab will be reported.

    Measured: Up to 3 years 5 months

  9. Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab

    Number of participants with ADAs to talquetamab and teclistamab will be reported.

    Measured: Up to 3 years 5 months

  10. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.

    Measured: Up to 3 years 5 months

  11. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level.

    Measured: Up to 3 years 5 months

  12. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Up to 3 years 5 months

  13. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."

    Measured: Up to 3 years 5 months

  14. Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.

    Measured: Up to 3 years 5 months

  15. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q

    Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale.

    Measured: Up to 3 years 5 months

  16. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30

    Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.

    Measured: Up to 3 years 5 months

  17. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L

    Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Up to 3 years 5 months

  18. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S

    Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe."

    Measured: Up to 3 years 5 months

  19. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey

    Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey.

    Measured: Up to 3 years 5 months

  20. Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30

    Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems.

    Measured: Up to 3 years 5 months

  21. Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    Measured: Up to 3 years 5 months

Timeline

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

  1. First posted17 Jan 2024
  2. Study start22 Jan 2024
  3. Primary completion1 Apr 2026
  4. Study completion31 Mar 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
838 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208150
Sponsor's protocol ID
64407564MMY3009
Other IDs
64407564MMY3009, 2022-502446-27-00
Acronym
MonumenTAL-6
Status last verified
Nov 2026
First submitted
5 Jan 2024
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 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Talquetamab, Pomalidomide and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 242 sites in 27 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 5 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 242 sites in United States, China, Japan, Spain, Brazil and 22 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 3 years 5 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 NCT06208150.

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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