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
NCT ID: NCT05455320
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
864 participants
INTERVENTIONAL
2022-10-13
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
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.
Daratumumab
Daratumumab will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
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.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Interventions
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Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
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
Hospitais Integradaos da Gavea S/A - DF Star
Brasília, , Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, , Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
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 RPUSP HCRP
Ribeirão Preto, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, , Brazil
Hospital Sao Rafael
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
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, , Brazil
Clinica Sao Germano
São Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
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 People's 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 Koelnt
Cologne, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Alexandra General Hospital of Athens
Athens Attica, , Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, , Greece
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, , Greece
Ha'Emek Medical Center
Afula, , Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Beilinson medical center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ziv Medical Center
Safed, , Israel
Sourasky (Ichilov) Medical Center
Tel Aviv, , Israel
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Ospedale Villa Sofia-Cervello
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, , Italy
Presidio Ospedaliero Santo Spirito in Sassia
Roma, , Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
A.O.U. Città della Salute e della Scienza
Torino, , Italy
Institute of Science Tokyo Hospital
Bunkyō City, , Japan
Chiba Cancer Center
Chiba, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Ogaki Municipal Hospital
Gifu, , Japan
Gunma University Hospital
Gunma, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Hyogo Medical University Hospital
Hyôgo, , Japan
Japanese Red Cross Society Himeji Hospital
Hyōgo, , Japan
Shonan Kamakura General Hospital
Kamakura-shi, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto Kuramaguchi Medical Center
Kyoto, , Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Iwate Medical University Hospital
Shiwa-gun, , Japan
The University of Osaka Hospital
Suita, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, , Poland
Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
Olsztyn, , Poland
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
Szczecin, , Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, , Poland
Dong-A University Hospital
Busan, , South Korea
National Cancer Center
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Jeonbuk National University Hospital
Jeonju, , 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. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. Virgen de La Arrixaca
El Palmar, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. de Leon
León, , Spain
Hosp. Univ. de La Princesa
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Univ Hm Sanchinarro
Madrid, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, , Spain
Hosp. Univ. Dr. Peset
Valencia, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Antalya Training And Research Hospital
Antalya, , Turkey (Türkiye)
Medipol Mega University Hospital
Istabul, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Ninewells Hospital & Medical School
Dundee, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Related Links
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Click here to learn more about the 64407564MMY3002 (MonumenTAL-3) trial
Other Identifiers
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64407564MMY3002
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000202-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2021-000202-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109082
Identifier Type: -
Identifier Source: org_study_id