Un estudio que compara talquetamab en combinación con daratumumab o en combinación con daratumumab y pomalidomida versus daratumumab en combinación con pomalidomida y dexametasona en participantes con mieloma múltiple en recaída o refractario (MonumenTAL-3)
Un estudio aleatorizado de fase 3 que compara talquetamab en combinación con daratumumab (SC) y pomalidomida (Tal-DP) o talquetamab (SC) en combinación con daratumumab SC (Tal-D) versus daratumumab SC, pomalidomida y dexametasona (DPd), en participantes con Mieloma múltiple en recaída o refractario que ha recibido al menos 1 línea de terapia previa
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Acceso ampliado
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 12203
- Charite Campus Benjamin Franklin
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Cologne, Alemania, 50937
- Universitaetsklinikum Koeln
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Hamburg, Alemania, 22763
- Asklepios Klinik Altona
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Heidelberg, Alemania, 69120
- Universitaetsklinikum Heidelberg
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Leipzig, Alemania, 04103
- Universitaetsklinikum Leipzig
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Mainz, Alemania, 55131
- Universitätsmedizin der Johannes Gutenberg Universität
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Würzburg, Alemania, 97080
- Universitaetsklinikum Wuerzburg
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Barretos, Brasil, 14784 400
- Fundacao Pio XII
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Belo Horizonte, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Brasília, Brasil, 70390-140
- IDOR - Regional Brasilia
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Caxias do Sul, Brasil, 95070 560
- Fundacao Universidade de Caxias do Sul
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Curitiba, Brasil, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brasil, 88020 210
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Natal, Brasil, 59062-000
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasil, 90050-170
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Ribeirão Preto, Brasil, 14051140
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Rio de Janeiro, Brasil, 22775 001
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brasil, 41253-190
- IDOR - Regional Bahia
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São Paulo, Brasil, 01321-001
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brasil, 01308 901
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 01323-000
- Hospital Paulistano
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São Paulo, Brasil, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasil, 01401 002
- IDOR - Regional Sao Paulo
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Brussels, Bélgica, 1090
- UZ Brussel
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Edegem, Bélgica, 2650
- UZA
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Hasselt, Bélgica, 3500
- Virga Jessa Ziekenhuis
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Liège, Bélgica, 4000
- CHC MontLegia
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Ottignies, Bélgica, 1340
- Clinique Saint Pierre
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Yvoir, Bélgica, 5530
- UCL Mont Godinne
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Brno, Chequia, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Chequia, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Chequia, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Chequia, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Chequia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Chequia, 128 08
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
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Busan, Corea del Sur, 602 812
- Dong-A University Hospital
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Gyeonggi-do, Corea del Sur, 10408
- National Cancer Center
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Incheon, Corea del Sur, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital
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Jeonju, Corea del Sur, 54907
- Jeonbuk National University Hospital
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Badalona, España, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, España, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, España, 08036
- Hosp Clinic de Barcelona
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Barcelona, España, 08035
- Hosp Univ Vall D Hebron
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El Palmar, España, 30120
- Hosp. Univ. Virgen de La Arrixaca
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Jerez de la Frontera, España, 11407
- Hosp. de Jerez de La Frontera
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León, España, 24071
- Hosp. de Leon
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Madrid, España, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, España, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, España, 28006
- Hosp. Univ. de La Princesa
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Madrid, España, 28050
- Hosp Univ Hm Sanchinarro
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Málaga, España, 29010
- Hosp Virgen de La Victoria
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Pamplona, España, 31008
- Clinica Univ. de Navarra
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Salamanca, España, 37007
- Hosp Clinico Univ de Salamanca
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San Cristóbal de La Laguna, España, 38320
- Hosp. Univ. de Canarias
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Valencia, España, 46017
- Hosp. Univ. Dr. Peset
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Arizona
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Tucson, Arizona, Estados Unidos, 85719
- The University of Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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Connecticut
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Norwalk, Connecticut, Estados Unidos, 06850
- Norwalk Hospital-oncology
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, Estados Unidos, 20037
- George Washington University
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Florida
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Healthcare System
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Miami, Florida, Estados Unidos, 33136
- University of Miami Health System
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University Of Illinois
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University Hospital & Clinics
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New Orleans, Louisiana, Estados Unidos, 70121-2429
- Ochsner Health System
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston University Medical Center
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General
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Worcester, Massachusetts, Estados Unidos, 01655
- University of Massachusetts Medical School
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Health System
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University Of Minnesota
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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Missouri
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St Louis, Missouri, Estados Unidos, 63110-1032
- Washington University School Of Medicine
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone Health
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute, Carolinas HealthCare System
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Charlotte, North Carolina, Estados Unidos, 28204
- Novant Health 1
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest Baptist Medical Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Novant Health
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, Estados Unidos, 43214
- OhioHealth
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Wexner Medical Center - James Cancer Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107-4215
- Thomas Jefferson University
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-8900
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38120
- Baptist Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
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Lubbock, Texas, Estados Unidos, 79410
- Joe Arrington Cancer Research Treatment Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University - Massey Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center
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Créteil, Francia, 94010
- APHP - Hopital Henri Mondor
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Dijon, Francia, 21000
- CHU Dijon
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Lyon, Francia, 69008
- Centre Leon Berard
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Montpellier, Francia, 34295
- CHU de Montpellier - Hopital Saint-Eloi
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Nantes, Francia, 44093
- CHU de Nantes hotel Dieu
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Nice, Francia, 06202
- CHU HOPITAL DE L'ARCHET - Hematology
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Paris, Francia, 75571
- CHU Hopital Saint Antoine
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Pessac, Francia, 33604
- CHRU - Hôpital du Haut Lévêque - Centre François Magendie
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Toulouse, Francia, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Athens Attica, Grecia, 115 28
- Alexandra General Hospital of Athens
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Thessaloniki, Grecia, 546 39
- Anticancer Hospital of Thessaloniki Theageneio
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Thessalonikis, Grecia, 570 10
- G Papanikolaou Hospital of Thessaloniki
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Afula, Israel, 1834111
- Ha'Emek Medical Center
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Be’er Ya‘aqov, Israel, 70300
- Shamir Medical Center Assaf Harofeh
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Hadera, Israel, 3810101
- Hillel Yaffe Medical Center
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Haifa, Israel, 31096
- Rambam Medical Center
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Haifa, Israel, 31048
- Bnai Zion Medical Center
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Haifa, Israel, 34362
- Carmel Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Nahariya, Israel, 22100
- Galilee Medical Center
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Petah Tikva, Israel, 49100
- Beilinson medical center
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Safed, Israel, 13100
- Ziv Medical Center
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Tel Aviv, Israel, 6423906
- Sourasky (Ichilov) Medical Center
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Ancona, Italia, 60126
- A.O. Universitaria Ospedali Riuniti di Ancona
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Bari, Italia, 70124
- Policlinico di Bari
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Bologna, Italia, 40138
- Azienda Ospedaliera Policlinico S. Orsola-Malpighi
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Brescia, Italia, 25123
- Azienda Ospedaliera Spedali Civili di Brescia
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Catania, Italia, 95123
- PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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Milan, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Italia, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Padova, Italia, 35128
- Azienda Ospedaliera Universitaria di Padova
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Palermo, Italia, 90146
- Ospedale Villa Sofia-Cervello
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Pavia, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo
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Reggio Emilia, Italia, 42123
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italia, 00193
- Presidio Ospedaliero Santo Spirito in Sassia
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San Giovanni Rotondo, Italia, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
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Torino, Italia, 10126
- A.O.U. Città della Salute e della Scienza
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Bunkyō City, Japón, 113 8519
- Institute of Science Tokyo Hospital
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Chiba, Japón, 260-8717
- Chiba Cancer Center
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Fukuoka, Japón, 814-0180
- Fukuoka University Hospital
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Gifu, Japón, 503-8502
- Ogaki Municipal Hospital
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Gunma, Japón, 371-0034
- Gunma University Hospital
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Hirakata, Japón, 573 1191
- Kansai Medical University Hospital
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Hyōgo, Japón, 670-8540
- Japanese Red Cross Society Himeji Hospital
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Kamakura-shi, Japón, 247-8533
- Shonan Kamakura General Hospital
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Kashiwa, Japón, 277 8577
- National Cancer Center Hospital East
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Koshigaya, Japón, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kumamoto, Japón, 860-8556
- Kumamoto University Hospital
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Kyoto, Japón, 603-8151
- Kyoto Kuramaguchi Medical Center
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Matsumoto, Japón, 399-8701
- National Hospital Organization Matsumoto Medical Center
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Niigata, Japón, 951-8566
- Niigata Cancer Center Hospital
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Nishinomiya Shi, Japón, 663 8501
- Hyogo Medical University Hospital
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Sapporo, Japón, 060-8648
- Hokkaido University Hospital
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Sendai, Japón, 980 8574
- Tohoku University Hospital
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Shiwa-gun, Japón, 028-3695
- Iwate Medical University Hospital
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Suita, Japón, 565 0871
- The University of Osaka Hospital
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Tokyo, Japón, 135 8550
- The Cancer Institute Hospital of JFCR
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Ōtake, Japón, 739-0696
- National Hospital Organization Hiroshima-Nishi Medical Center
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Dordrecht, Países Bajos, 3318 AT
- Albert Schweitzer ziekenhuis-lokatie Dordwijk
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Eindhoven, Países Bajos, 5631 BM
- Maxima Medisch Centrum
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Rotterdam, Países Bajos, 3015
- Erasmus MC
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Brzozów, Polonia, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Gdansk, Polonia, 80 214
- Uniwersyteckie Centrum Kliniczne
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Katowice, Polonia, 40 519
- Pratia Onkologia Katowice
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Kielce, Polonia, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Krakow, Polonia, 30 688
- Szpital Uniwersytecki w Krakowie
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Lublin, Polonia, 20090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Olsztyn, Polonia, 10-228
- Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
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Szczecin, Polonia, 71-252
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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Torun, Polonia, 87 100
- Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
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Warsaw, Polonia, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Wroclaw, Polonia, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Beijing, Porcelana, 100034
- Peking University First Hospital
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Beijing, Porcelana, 100006
- Peking Union Medical College Hospital
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Changchun, Porcelana, 130021
- The First Hospital of Jilin University
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Changsha, Porcelana, 410000
- The second Xiangya Hospital of Central South University
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Chaoyang District, Porcelana, 100020
- Beijing Chaoyang Hospital
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Chengdu, Porcelana, 610072
- Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
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Fuzhou, Porcelana, 350001
- Fujian Medical University Union Hospital
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Guangzhou, Porcelana, 510080
- Guangdong Provincial People's Hospital
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Guangzhou, Porcelana, 510710
- Sun Yat Sen University Cancer Center
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Hangzhou, Porcelana, 310003
- The First Affiliated Hospital Zhejiang University College of Medicine
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Nanjing, Porcelana, 210008
- Nanjing Drum Tower Hospital
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Shanghai, Porcelana, 200065
- Tongji Hospital of Tongji University
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Shanghai, Porcelana, 200434
- Shanghai Fourth People s Hospital
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Shenzhen, Porcelana, 518036
- Peking University Shenzhen Hospital
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Suzhou, Porcelana, 215006
- First Affiliated Hospital SooChow University
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Tianjin, Porcelana, 300320
- Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
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Tianjin, Porcelana, 300060
- Tianjin cancer hospital
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Wuhan, Porcelana, 430030
- Tongji Hospital, Tongji Medical College of HUST
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Zhengzhou, Porcelana, 450008
- Henan Cancer Hospital
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Blackpool, Reino Unido, FY3 8NR
- Blackpool Victoria Hospital
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Dundee, Reino Unido, DD1 9SY
- Ninewells Hospital & Medical School
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London, Reino Unido, W12 0HS
- Hammersmith Hospital
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Newcastle Freeman Hospital
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Nottingham, Reino Unido, NG5 1PB
- Nottingham City Hospital
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Plymouth, Reino Unido, PL6 8DH
- University Hospitals Plymouth NHS Trust
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Sutton, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Wolverhampton, Reino Unido, WV10 0QP
- New Cross Hospital
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Kaohsiung City, Taiwán, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung City, Taiwán, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Tainan, Taiwán, 704
- National Cheng Kung University Hospital
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Taipei, Taiwán, 10048
- National Taiwan University Hospital
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Ankara, Turquía (Türkiye), 06680
- Liv Hospital Ankara
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Ankara, Turquía (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
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Ankara, Turquía (Türkiye), 06590
- Ankara University Medical Faculty
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Antalya, Turquía (Türkiye), 07100
- Antalya Egitim ve Arastirma Hastanesi
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Istanbul, Turquía (Türkiye), 34093
- Istanbul University Istanbul Medical Faculty
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Istanbul, Turquía (Türkiye), 34214
- Medipol Mega University Hospital
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Istanbul, Turquía (Türkiye), 34153
- Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi
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Izmir, Turquía (Türkiye), 35330
- Dokuz Eylul University Medical Faculty
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Samsun, Turquía (Türkiye), 55139
- Ondokuz Mayis University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
- Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
Exclusion Criteria:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- Received prior pomalidomide therapy
- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug Access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
Talquetamab will be administered subcutaneously.
Otros nombres:
Pomalidomide will be administered orally. Dexamethasone will be administered orally or intravenously. Daratumumab will be administered subcutaneously. |
|
Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
Pomalidomide will be administered orally. Dexamethasone will be administered orally or intravenously. Daratumumab will be administered subcutaneously. |
|
Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
Talquetamab will be administered subcutaneously.
Otros nombres:
Dexamethasone will be administered orally or intravenously. Daratumumab will be administered subcutaneously. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-Free Survival (PFS)
Periodo de tiempo: Up to 6 years 6 months
|
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first. |
Up to 6 years 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Response (Partial Response [PR] or Better)
Periodo de tiempo: Up to 6 years 6 months
|
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria. |
Up to 6 years 6 months
|
|
Very Good Partial Response (VGPR) or Better Rate
Periodo de tiempo: Up to 6 years 6 months
|
VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria. |
Up to 6 years 6 months
|
|
Complete Response (CR) or Better Rate
Periodo de tiempo: Up to 6 years 6 months
|
CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria. |
Up to 6 years 6 months
|
|
Overall Minimal Residual Disease (MRD) Negative CR
Periodo de tiempo: Up to 6 years 6 months
|
MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy. |
Up to 6 years 6 months
|
|
Overall Survival (OS)
Periodo de tiempo: Up to 6 years 6 months
|
OS is defined as the time from the date of randomization to the date of the participant's death. |
Up to 6 years 6 months
|
|
Progression-free Survival on Next-line Therapy (PFS2)
Periodo de tiempo: Up to 6 years 6 months
|
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. |
Up to 6 years 6 months
|
|
Time to Next Therapy (TTNT)
Periodo de tiempo: Up to 6 years 6 months
|
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. |
Up to 6 years 6 months
|
|
Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Up to 6 years 6 months
|
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 6 years 6 months
|
|
Number of Participants with AEs by Severity
Periodo de tiempo: Up to 6 years 6 months
|
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). |
Up to 6 years 6 months
|
|
Serum Concentrations of Talquetamab
Periodo de tiempo: Up to 6 years 6 months
|
Serum concentrations of talquetamab will be reported. |
Up to 6 years 6 months
|
|
Serum Concentrations of Daratumumab
Periodo de tiempo: Up to 6 years 6 months
|
Serum concentrations of daratumumab will be reported. |
Up to 6 years 6 months
|
|
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab
Periodo de tiempo: Up to 6 years 6 months
|
Number of participants with presence ADAs to talquetamab will be reported. |
Up to 6 years 6 months
|
|
Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab
Periodo de tiempo: Up to 6 years 6 months
|
Number of participants with presence of ADAs to daratumumab will be reported. |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Periodo de tiempo: Up to 6 years 6 months
|
The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Periodo de tiempo: Up to 6 years 6 months
|
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank. |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Periodo de tiempo: Up to 6 years 6 months
|
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Periodo de tiempo: Up to 6 years 6 months
|
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Periodo de tiempo: Up to 6 years 6 months
|
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. |
Up to 6 years 6 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Periodo de tiempo: Up to 6 years 6 months
|
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population. |
Up to 6 years 6 months
|
|
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Periodo de tiempo: Baseline up to 6 years 6 months
|
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. |
Baseline up to 6 years 6 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c
Periodo de tiempo: Baseline up to 6 years 6 months
|
The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank. |
Baseline up to 6 years 6 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Periodo de tiempo: Baseline up to 6 years 6 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. |
Baseline up to 6 years 6 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE
Periodo de tiempo: Baseline up to 6 years 6 months
|
The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. |
Baseline up to 6 years 6 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Periodo de tiempo: Baseline up to 6 years 6 months
|
The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses. |
Baseline up to 6 years 6 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)
Periodo de tiempo: Baseline up to 6 years 6 months
|
The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population. |
Baseline up to 6 years 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Enfermedades hemic y linfáticas
- Mieloma múltiple
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Esparrazadienetrioles
- Dexametasona
- pomalidomida
- daratumumab
- talquetamab
Otros números de identificación del estudio
- CR109082
- 2021-000202-22 (Número EudraCT)
- 64407564MMY3002 (Otro identificador: Janssen Research & Development, LLC)
- 2023-503467-41-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .