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ACTIVE NOT RECRUITING
NCT05455320
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2022-10-13

Completion Date

2029-06-30

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DRUG

Talquetamab

Talquetamab will be administered subcutaneously.

DRUG

Daratumumab

Daratumumab will be administered subcutaneously.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

DRUG

Dexamethasone

Dexamethasone will be administered orally or intravenously.

Locations (216)

The University of Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Norwalk Hospital-oncology

Norwalk, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

George Washington University

Washington D.C., District of Columbia, United States

Memorial Healthcare System

Hollywood, Florida, United States

University of Miami Health System

Miami, Florida, United States

University Of Illinois

Chicago, Illinois, United States

University of Kansas

Westwood, Kansas, United States

Tulane University Hospital & Clinics

New Orleans, Louisiana, United States

Ochsner Health System

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General

Boston, Massachusetts, United States

Boston University Medical Center

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University Of Minnesota

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone Health

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Cancer Institute, Carolinas HealthCare System

Charlotte, North Carolina, United States

Novant Health

Charlotte, North Carolina, United States

Novant Health

Winston-Salem, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, United States

OhioHealth

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Houston Methodist Hospital

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Joe Arrington Cancer Research Treatment Center

Lubbock, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

UZ Brussel

Brussels, Belgium

UZA

Edegem, Belgium

Virga Jessa Ziekenhuis

Hasselt, Belgium

CHC MontLegia

Liège, Belgium

Clinique Saint Pierre

Ottignies, Belgium

UCL Mont Godinne

Yvoir, Belgium

Fundacao Pio XII

Barretos, Brazil

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil

Hospitais Integradaos da Gavea S/A - DF Star

Brasília, Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, Brazil

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

Rio de Janeiro, Brazil

Hospital Sao Rafael

Salvador, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Hospital Paulistano

São Paulo, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, Brazil

Clinica Sao Germano

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

The second Xiangya Hospital of Central South University

Changsha, China

Beijing Chaoyang Hospital

Chaoyang District, China

Sichuan Academy of Medical Science Sichuan Provincial People's Hospital

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

Sun Yat Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

Tongji Hospital of Tongji University

Shanghai, China

Shanghai Fourth People s Hospital

Shanghai, China

Peking University Shenzhen Hospital

Shenzhen, China

First Affiliated Hospital SooChow University

Suzhou, China

Tianjin cancer hospital

Tianjin, China

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

Tianjin, China

Tongji Hospital, Tongji Medical College of HUST

Wuhan, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

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

Prague, Czechia

APHP - Hopital Henri Mondor

Créteil, France

CHU Dijon

Dijon, France

Centre Leon Berard

Lyon, France

CHU de Montpellier - Hopital Saint-Eloi

Montpellier, France

CHU de Nantes hotel Dieu

Nantes, France

CHU HOPITAL DE L'ARCHET - Hematology

Nice, France

CHU Hopital Saint Antoine

Paris, France

CHRU - Hôpital du Haut Lévêque - Centre François Magendie

Pessac, France

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, France

Charite Campus Benjamin Franklin

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Asklepios Klinik Altona

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitätsmedizin der Johannes Gutenberg Universität

Mainz, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Alexandra General Hospital of Athens

Athens Attica, Greece

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, Greece

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, Greece

Ha'Emek Medical Center

Afula, Israel

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, Israel

Hillel Yaffe Medical Center

Hadera, Israel

Bnai Zion Medical Center

Haifa, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Beilinson medical center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Ziv Medical Center

Safed, Israel

Sourasky (Ichilov) Medical Center

Tel Aviv, Israel

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Policlinico di Bari

Bari, Italy

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera Universitaria di Padova

Padova, Italy

Ospedale Villa Sofia-Cervello

Palermo, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, Italy

Presidio Ospedaliero Santo Spirito in Sassia

Roma, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

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

Torino, Italy

Institute of Science Tokyo Hospital

Bunkyō City, Japan

Chiba Cancer Center

Chiba, Japan

Fukuoka University Hospital

Fukuoka, Japan

Ogaki Municipal Hospital

Gifu, Japan

Gunma University Hospital

Gunma, Japan

Kansai Medical University Hospital

Hirakata, Japan

Hyogo Medical University Hospital

Hyôgo, Japan

Japanese Red Cross Society Himeji Hospital

Hyōgo, Japan

Shonan Kamakura General Hospital

Kamakura-shi, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kyoto Kuramaguchi Medical Center

Kyoto, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan

Niigata Cancer Center Hospital

Niigata, Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, Japan

Hokkaido University Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

The University of Osaka Hospital

Suita, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Albert Schweitzer ziekenhuis-lokatie Dordwijk

Dordrecht, Netherlands

Maxima Medisch Centrum

Eindhoven, Netherlands

Erasmus MC

Rotterdam, Netherlands

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Pratia Onkologia Katowice

Katowice, Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, Poland

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

Olsztyn, Poland

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

Szczecin, Poland

Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu

Torun, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

Dong-A University Hospital

Busan, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. Virgen de La Arrixaca

El Palmar, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. de Leon

León, Spain

Hosp. Univ. de La Princesa

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

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

Ankara, Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, Turkey (Türkiye)

Liv Hospital Ankara

Ankara, Turkey (Türkiye)

Antalya Training And Research Hospital

Antalya, Turkey (Türkiye)

Medipol Mega University Hospital

Istabul, Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Blackpool Victoria Hospital

Blackpool, United Kingdom

Ninewells Hospital & Medical School

Dundee, United Kingdom

Hammersmith Hospital

London, United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom