RecruitingPhase 2NCT04634552

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

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Sponsor

Janssen Research & Development, LLC

Enrollment

510 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Hematological Malignancies

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing talquetamab — a bispecific antibody that helps the immune system find and destroy multiple myeloma (a blood cancer) cells — in patients whose disease has relapsed (come back) or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma and have already received prior treatment - Your myeloma is measurable by lab tests - Your general health status is acceptable (ECOG 0–2) - Women of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - You have had prior CAR-T cell therapy (for some cohorts) or T cell redirection therapy within 3 months - You have had a stroke or seizure within the past 6 months - You still have significant side effects from prior treatments - You have taken high doses of steroids recently - Your organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalquetamab

Talquetamab will be administered SC until disease progression.

Locations(78)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

City of Hope

Duarte, California, United States

Memorial Healthcare System

Hollywood, Florida, United States

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Washington University School Of Medicine

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Tennessee Oncology

Nashville, Tennessee, United States

UZ Antwerpen

Edegem, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège - Domaine Universitaire du Sart Tilman

Liège, Belgium

UCL - Saint Luc

Woluwe-Saint-Lambert, Belgium

Peking University Third Hospital

Beijing, China

Sun Yat Sen University Cancer Center

Guangzhou, China

The 1st Affiliated Hospital Of Medical College Zhejiang University 1

Hangzhou, China

The 1St Affiliated Hospital of Medical College Zhejiang University

Hangzhou, China

First Affiliated Hospital SooChow University

Suzhou, China

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

Tianjin, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

CHU Henri Mondor

Créteil, France

Hospices Civils de Lyon HCL

Lyon, France

CHU de Montpellier Hopital Saint Eloi

Montpellier, France

C.H.U. Hotel Dieu - France

Nantes, France

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, France

Pôle IUC Oncopole CHU

Toulouse, France

Charite Campus Benjamin Franklin

Berlin, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Muenster

Münster, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Kameda Medical Center

Chiba, Japan

Fukuoka University Hospital

Fukuoka, Japan

Ogaki Municipal Hospital

Gifu, Japan

Teine Keijinkai Hospital

Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kurashiki Central Hospital

Kurashiki, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Japanese Red Cross Osaka Hospital

Osaka, Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, Japan

Iwate Medical University Hospital

Shiwa-gun, Japan

VU Medisch Centrum

Amsterdam, Netherlands

UMCU

Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

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

Gliwice, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

Chonnam National University Hwasun Hospital

Jeollanam-do, 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 Univ Vall D Hebron

Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. Virgen de La Arrixaca

Murcia, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Del Rocio

Seville, Spain

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