Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy
Study ID: NCT05455320
Conditions
Study Description
Brief Summary: 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).
Detailed Description: Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group \[ECOG\] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, District of Columbia, United States
George Washington University, Washington, 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, Saint 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, Brussel, , 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, Brasilia, , 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, Florianopolis, , 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
Hospital Paulistano, Sao Paulo, , Brazil
Instituto D Or de Pesquisa e Ensino (IDOR), Sao Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center, Sao Paulo, , Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo, , Brazil
Clinica Sao Germano, São Paulo, , Brazil
Peking Union Medical College Hospital, Beijing, , China
Beijing Chaoyang 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
Sichuan Academy of Medical Science Sichuan Provincial People's Hospital, Chengdu, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
Guangdong Provincial People's Hospital, 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, Su Zhou, , 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 Kralove, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie, Praha 2, , Czechia
APHP - Hopital Henri Mondor, Creteil, , France
CHU Dijon, Dijon, , France
Centre Leon Berard, Lyon, , France
CHU de Montpellier - Hopital Saint-Eloi, Montpellier Cedex 5, , France
CHU de Nantes hotel Dieu, Nantes, , France
CHU HOPITAL DE L'ARCHET - Hematology, Nice N/a, , France
CHU Hopital Saint Antoine, Paris Cedex 12, , France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie, Pessac, , France
Institut Universitaire du cancer de Toulouse-Oncopole, TOULOUSE Cedex 9, , France
Charite Campus Benjamin Franklin, Berlin, , Germany
Asklepios Klinik Altona, Hamburg, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Koelnt, Koeln, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg Universität, Mainz, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Alexandra General Hospital of Athens, Athens Attica, , Greece
G Papanikolaou Hospital of Thessaloniki, Thessalonikis, , Greece
Anticancer Hospital of Thessaloniki Theageneio, Thessaloniki, , Greece
Ha'Emek Medical Center, Afula, , Israel
Shamir Medical Center (Assaf Harofeh), Be'er Ya'akov, , 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, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliera Universitaria di Padova, Padova, , 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
Tokyo Medical and Dental University Hospital, Bunkyo Ku, , 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
Japanese Red Cross Society Himeji Hospital, Hyogo, , Japan
Hyogo Medical University Hospital, Hyôgo, , 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
Hiroshima West Medical Center, Otake, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Tohoku University Hospital, Sendai, , Japan
Iwate Medical University Hospital, Shiwa-gun, , Japan
Osaka University Hospital, Suita-shi, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Dong-A University Hospital, Busan, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
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, Brzozow, , 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, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw, , Poland
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, Murcia, , Spain
Hosp. de Jerez de La Frontera, Jerez de la Frontera, , Spain
Hosp. de Leon, Leon, , 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, Malaga, , 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, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung City, , 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
Ankara University Medical Faculty, Ankara, , Turkey
Liv Hospital Ankara, Ankara, , Turkey
Antalya Training And Research Hospital, Antalya, , Turkey
Medipol Mega University Hospital, Istabul, , Turkey
Istanbul University Istanbul Medical Faculty, Istanbul, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Dokuz Eylul University Medical Faculty, Izmir, , Turkey
On Dokuz Mayıs University Medical Faculty, Samsun, , Turkey
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
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
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