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

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Bone Diseases

Leukemia

Cancer

Treatment

Talquetamab

Clinical Study ID

NCT04634552
CR108920
TALMMY1001-PT3
2023-504581-29-00
2017-002400-26
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Documented initial diagnosis of multiple myeloma according to international myelomaworking group (IMWG) diagnostic criteria

  • Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiplemyeloma must be measurable by central 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 andprior to the first dose of study drug using a highly sensitive pregnancy test eitherserum (beta human chorionic gonadotropin [hCG]) or urine

  • Willing and able to adhere to the prohibitions and restrictions specified in thisprotocol

Exclusion

Exclusion Criteria:

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirectiontherapy at any time. Cohort B and Cohort D: T cell redirection therapy within 3months

  • Toxicities from previous anticancer therapies should have resolved to baselinelevels or to Grade 1 or less except for alopecia or peripheral neuropathy

  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) ofprednisone within the 14-day period before the first dose of study drug (does notinclude pretreatment medication)

  • Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Study Design

Total Participants: 480
Treatment Group(s): 1
Primary Treatment: Talquetamab
Phase: 2
Study Start date:
February 01, 2021
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Universitair Ziekenhuis - Antwerpen

    Antwerp, 2650
    Belgium

    Site Not Available

  • UCL - Saint Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000
    Belgium

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • Second Affiliated Hospital of Army Medical University

    Chongqing, 400037
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060
    China

    Active - Recruiting

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310003
    China

    Site Not Available

  • The 1St Affiliated Hospital of Medical College Zhejiang University

    Hangzhou, 310003
    China

    Site Not Available

  • First Affiliated Hospital SooChow University

    Su Zhou, 215006
    China

    Active - Recruiting

  • First Affiliated Hospital, SooChow University

    Su Zhou, 215006
    China

    Active - Recruiting

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

    Tianjin, 300320
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    XI An Shi, 710063
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    XI An Shi, 710063
    China

    Active - Recruiting

  • First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

    Xi'an, 710061
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004
    China

    Completed

  • CHU Henri Mondor

    Creteil, 94000
    France

    Active - Recruiting

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU de Montpellier, Hopital Saint-Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • C.H.U. Hotel Dieu - France

    Nantes, 44093
    France

    Active - Recruiting

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac cedex, 33604
    France

    Active - Recruiting

  • Centre hospitalier Lyon-Sud

    Pierre Benite cedex, 69495
    France

    Active - Recruiting

  • Pôle IUC Oncopole CHU

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • Charite Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Universitatsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Completed

  • Klinikum Großhadern der Ludwig-Maximilians-Universität

    München, 81377
    Germany

    Site Not Available

  • Universitatsklinikum Wurzburg

    Wuerzburg, 97080
    Germany

    Active - Recruiting

  • Universitatsklinikum Wurzburg

    Würzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97080
    Germany

    Active - Recruiting

  • Carmel Medical Center

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Kameda General Hospital

    Chiba, 296-8602
    Japan

    Site Not Available

  • Kameda Medical Center

    Chiba, 296-8602
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Gifu, 503-8502
    Japan

    Site Not Available

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555
    Japan

    Completed

  • Kobe City Medical Center General Hospital

    Hyogo, 650-0047
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe City, 650 0047
    Japan

    Site Not Available

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, 343-8555
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki, 710-8602
    Japan

    Site Not Available

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya, 467-8602
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555
    Japan

    Site Not Available

  • Hiroshima West Medical Center

    Otake, 739-0696
    Japan

    Site Not Available

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Otake, 739-0696
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695
    Japan

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun Gun, 58128
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Completed

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Completed

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Completed

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Completed

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Completed

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • UMCU

    Utrecht, 3584 CX
    Netherlands

    Completed

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214
    Poland

    Site Not Available

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

    Gliwice, 44102
    Poland

    Completed

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

    Gliwice, 44102
    Poland

    Completed

  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

    Lublin, 20090
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warszawa, 02-781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warszawa, 02-781
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Completed

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 8908
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Completed

  • Hosp. Univ. 12 De Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Completed

  • Hosp. Univ. Virgen de La Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcon, 28223
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Completed

  • Scripps Clinic

    La Jolla, California 92037
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Oschner Health System

    New Orleans, Louisiana 70121-2429
    United States

    Site Not Available

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Cancer Institute

    Detroit, Michigan 48202-2608
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10023
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center - James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

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