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NCT04634552PHASE2Recruiting

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

Janssen Research & Development, LLC

Start Date

2/1/2021

Completion Date

3/30/2029

Summary

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria * Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin \[hCG\]) or urine * Willing and able to adhere to the prohibitions and restrictions specified in this protocol Exclusion Criteria: * Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) * Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Interventions

DRUG

Talquetamab

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Conditions

Hematological Malignancies

Locations

University of Alabama Birmingham

Birmingham, Alabama 35294

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

City of Hope

Duarte, California 91010

United States

Memorial Healthcare System

Hollywood, Florida 33021

United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322

United States

University of Chicago

Chicago, Illinois 60637

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

University of Michigan Health System

Ann Arbor, Michigan 48109

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

NYU Langone Health

New York, New York 10016

United States

Mount Sinai Medical Center

New York, New York 10023

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

UZ Antwerpen

Edegem, 2650

Belgium

UZ Leuven

Leuven, 3000

Belgium

CHU de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

UCL - Saint Luc

Woluwe-Saint-Lambert, 1200

Belgium

Peking University Third Hospital

Beijing, 100191

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

The 1st Affiliated Hospital Of Medical College Zhejiang University 1

Hangzhou, 310003

China

The 1St Affiliated Hospital of Medical College Zhejiang University

Hangzhou, 310003

China

First Affiliated Hospital SooChow University

Suzhou, 215006

China

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

Tianjin, 300320

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710063

China

CHU Henri Mondor

Créteil, 94000

France

Hospices Civils de Lyon HCL

Lyon, 69002

France

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295

France

C.H.U. Hotel Dieu - France

Nantes, 44093

France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33604

France

Pôle IUC Oncopole CHU

Toulouse, 31059

France

Charite Campus Benjamin Franklin

Berlin, 12203

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitaetsklinikum Muenster

Münster, 48149

Germany

Universitatsklinikum Wurzburg

Würzburg, 97080

Germany

Rambam Medical Center

Haifa, 31096

Israel

Carmel Medical Center

Haifa, 3436212

Israel

Hadassah Medical Center

Jerusalem, 91120

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Kameda Medical Center

Chiba, 296-8602

Japan

Fukuoka University Hospital

Fukuoka, 814-0180

Japan

Ogaki Municipal Hospital

Gifu, 503-8502

Japan

Teine Keijinkai Hospital

Hokkaido, 006-8555

Japan

Kobe City Medical Center General Hospital

Kobe, 650 0047

Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, 343-8555

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Kurashiki Central Hospital

Kurashiki, 710-8602

Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, 399-8701

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Japanese Red Cross Osaka Hospital

Osaka, 543 8555

Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, 739-0696

Japan

Iwate Medical University Hospital

Shiwa-gun, 028-3695

Japan

VU Medisch Centrum

Amsterdam, 1081 HV

Netherlands

UMCU

Utrecht, 3584 CX

Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

Gliwice, 44102

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02-781

Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50 367

Poland

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591

South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 8908

Spain

Hosp Univ Fund Jimenez Diaz

Madrid, 28040

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Univ. Virgen de La Arrixaca

Murcia, 30120

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain