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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

2028-05-25

Last Updated

2026-11-03

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 1

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

IDOR - Regional Brasilia

Brasília, Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, Brazil

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

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

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 Ribeirao Preto

Ribeirão Preto, Brazil

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

Rio de Janeiro, Brazil

IDOR - Regional Bahia

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

IDOR - Regional Sao Paulo

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Clinica Medica Sao Germano LTDA

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 Peoples 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

And 116 more locations on ClinicalTrials.gov