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 o...

Last Updated   April 24, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Sites
    216 sites
  • Status
    Recruiting

SUMMARY

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.

CONDITIONS

  • Relapsed or Refractory Multiple Myeloma

ELIGIBILITY

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

DETAILS

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.

LOCATIONS

Locations in:
United States, United Kingdom, Turkey, Taiwan, Spain, South Korea, Poland, Netherlands, Japan, Italy, Israel, Greece, Germany, France, Czechia, China, Brazil, Belgium
Country (18) City or Province (216) Status
United States Ann Arbor, MI University of Michigan Health System
RECRUITING
United States Baltimore, MD Johns Hopkins University
RECRUITING
United States Boston, MA Boston University Medical Center
RECRUITING
United States Boston, MA Massachusetts General
RECRUITING
United States Chapel Hill, NC University of North Carolina
RECRUITING
United States Charleston, SC Medical University of South Carolina
RECRUITING
United States Charlotte, NC Levine Cancer Institute, Carolinas HealthCare System
RECRUITING
United States Charlotte, NC Novant Health
RECRUITING
United States Charlottesville, VA University of Virginia
RECRUITING
United States Chicago, IL University Of Illinois
RECRUITING
United States Cleveland, OH University Hospitals Cleveland Medical Center
RECRUITING
United States Columbus, OH OhioHealth
RECRUITING
United States Columbus, OH The Ohio State University Wexner Medical Center - James Cancer Hospital
RECRUITING
United States Hollywood, FL Memorial Healthcare System
RECRUITING
United States Houston, TX Houston Methodist Hospital
RECRUITING
United States Houston, TX MD Anderson Cancer Center
RECRUITING
United States Jackson, MS University of Mississippi Medical Center
RECRUITING
United States Little Rock, AR University of Arkansas for Medical Sciences
RECRUITING
United States Lubbock, TX Joe Arrington Cancer Research Treatment Center
RECRUITING
United States Memphis, TN Baptist Cancer Center
RECRUITING
United States Miami, FL University of Miami Health System
RECRUITING
United States Minneapolis, MN University Of Minnesota
RECRUITING
United States New Brunswick, NJ Rutgers Cancer Institute of New Jersey
RECRUITING
United States New Orleans, LA Ochsner Health System
RECRUITING
United States New Orleans, LA Tulane University Hospital & Clinics
RECRUITING
United States New York, NY NYU Langone Health
COMPLETED
United States Norwalk, CT Norwalk Hospital-oncology
RECRUITING
United States Philadelphia, PA Thomas Jefferson University
RECRUITING
United States Richmond, VA Virginia Commonwealth University - Massey Cancer Center
RECRUITING
United States Saint Louis, MO Washington University School of Medicine
RECRUITING
United States Salt Lake City, UT Huntsman Cancer Institute
RECRUITING
United States Seattle, WA Fred Hutchinson Cancer Research Center
RECRUITING
United States Syracuse, NY SUNY Upstate Medical University
RECRUITING
United States Tucson, AZ The University of Arizona Cancer Center
RECRUITING
United States Washington, DC George Washington University
RECRUITING
United States Washington, DC MedStar Georgetown University Hospital
RECRUITING
United States Westwood, KS University of Kansas
RECRUITING
United States Winston-Salem, NC Novant Health
RECRUITING
United States Winston-Salem, NC Wake Forest Baptist Medical Center
RECRUITING
United States Worcester, MA University of Massachusetts Medical School
RECRUITING
United Kingdom Blackpool Blackpool Victoria Hospital
RECRUITING
United Kingdom Dundee Ninewells Hospital & Medical School
RECRUITING
United Kingdom London Imperial College Healthcare
RECRUITING
United Kingdom Newcastle Upon Tyne Newcastle Freeman Hospital
RECRUITING
United Kingdom Nottingham Nottingham City Hospital
RECRUITING
United Kingdom Plymouth University Hospitals Plymouth NHS Trust
RECRUITING
United Kingdom Sutton Royal Marsden Hospital
RECRUITING
United Kingdom Wolverhampton, WMD New Cross Hospital
RECRUITING
Turkey Ankara Ankara University Medical Faculty
RECRUITING
Turkey Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
RECRUITING
Turkey Ankara Liv Hospital Ankara
RECRUITING
Turkey Antalya Antalya Training And Research Hospital
RECRUITING
Turkey Istabul Medipol Mega University Hospital
RECRUITING
Turkey Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Turkey Istanbul Istanbul University Istanbul Medical Faculty
SUSPENDED
Turkey Izmir Dokuz Eylul University Medical Faculty
RECRUITING
Turkey Samsun On Dokuz Mayıs University Medical Faculty
RECRUITING
Taiwan Kaohsiung Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Taiwan Kaohsiung Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Taiwan Taichung City China Medical University Hospital
RECRUITING
Taiwan Tainan National Cheng Kung University Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
Spain Badalona, BA Hosp. Univ. Germans Trias I Pujol
RECRUITING
Spain Barcelona, BA Hosp. Clinic de Barcelona
RECRUITING
Spain Barcelona, BA Hosp. Univ. Vall D Hebron
RECRUITING
Spain Barcelona, BA Hosp. de La Santa Creu I Sant Pau
RECRUITING
Spain El Palmar, Murcia, MU Hosp. Univ. Virgen de La Arrixaca
RECRUITING
Spain Jerez de la Frontera Hosp. de Jerez de La Frontera
RECRUITING
Spain Leon Hosp. de Leon
RECRUITING
Spain Madrid, MD Hosp. Univ. 12 de Octubre
RECRUITING
Spain Madrid, MD Hosp. Univ. Hm Sanchinarro
RECRUITING
Spain Madrid, MD Hosp. Univ. Ramon Y Cajal
RECRUITING
Spain Madrid, MD Hosp. Univ. de La Princesa
RECRUITING
Spain Malaga Hosp. Virgen de La Victoria
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Salamanca, SL Hosp. Clinico Univ. de Salamanca
RECRUITING
Spain San Cristóbal de La Laguna Hosp. Univ. de Canarias
RECRUITING
Spain Valencia, VC Hosp. Univ. Dr. Peset
RECRUITING
South Korea Busan Dong-A University Hospital
RECRUITING
South Korea Gyeonggi-do, 41 National Cancer Center
RECRUITING
South Korea Incheon Gachon University Gil Medical Center
RECRUITING
South Korea Jeollanam-do, 46 Chonnam National University Hwasun Hospital
RECRUITING
South Korea Jeonju-si, 45 Jeonbuk National University Hospital
RECRUITING
South Korea Seoul Asan Medical Center
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
South Korea Seoul Severance Hospital, Yonsei University Health System
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St. Mary's Hospital
RECRUITING
Poland Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
RECRUITING
Poland Gdansk Uniwersyteckie Centrum Kliniczne
RECRUITING
Poland Katowice Pratia Onkologia Katowice
RECRUITING
Poland Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Poland Krakow Szpital Uniwersytecki w Krakowie
COMPLETED
Poland Lublin Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
RECRUITING
Poland Olsztyn Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
COMPLETED
Poland Szczecin Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
RECRUITING
Poland Torun Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
RECRUITING
Poland Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Poland Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING
Netherlands Dordrecht Albert Schweitzer ziekenhuis-lokatie Dordwijk
ACTIVE_NOT_RECRUITING
Netherlands Eindhoven Maxima Medisch Centrum
ACTIVE_NOT_RECRUITING
Netherlands Rotterdam Erasmus MC
ACTIVE_NOT_RECRUITING
Japan Bunkyo-Ku, 13 Tokyo Medical and Dental University Hospital
RECRUITING
Japan Chiba Chiba Cancer Center
RECRUITING
Japan Fukuoka Fukuoka University Hospital
RECRUITING
Japan Gifu Ogaki Municipal Hospital
RECRUITING
Japan Gunma, 10 Gunma University Hospital
RECRUITING
Japan Hirakata, 27 Kansai Medical University Hospital
RECRUITING
Japan Hyogo, 28 Japanese Red Cross Society Himeji Hospital
RECRUITING
Japan Hyôgo, 28 Hyogo Medical University Hospital
RECRUITING
Japan Kamakura-shi, 14 Shonan Kamakura General Hospital
RECRUITING
Japan Kashiwa National Cancer Center Hospital East
RECRUITING
Japan Koshigaya, 11 Dokkyo Medical University Saitama Medical Center
RECRUITING
Japan Kumamoto, 43 Kumamoto University Hospital
RECRUITING
Japan Kyoto, 26 Kyoto Kuramaguchi Medical Center
RECRUITING
Japan Matsumoto, 20 National Hospital Organization Matsumoto Medical Center
RECRUITING
Japan Niigata, 15 Niigata Cancer Center Hospital
RECRUITING
Japan Otake Hiroshima West Medical Center
RECRUITING
Japan Sapporo-shi, 01 Hokkaido University Hospital
RECRUITING
Japan Sendai, 04 Tohoku University Hospital
RECRUITING
Japan Shiwa-gun, 03 Iwate Medical University Hospital
RECRUITING
Japan Suita-shi, 27 Osaka University Hospital
RECRUITING
Japan Tokyo, 13 The Cancer Institute Hospital of JFCR
RECRUITING
Italy Ancona A.O. Universitaria Ospedali Riuniti di Ancona
RECRUITING
Italy Bari Policlinico di Bari
RECRUITING
Italy Bologna Azienda Ospedaliera Policlinico S. Orsola-Malpighi
RECRUITING
Italy Brescia Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING
Italy Catania PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
RECRUITING
Italy Milano ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Italy Milano Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Italy Padova Azienda Ospedaliera Universitaria di Padova
RECRUITING
Italy Palermo Ospedale Villa Sofia-Cervello
RECRUITING
Italy Pavia Fondazione IRCCS Policlinico San Matteo
RECRUITING
Italy Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Italy Roma Presidio Ospedaliero Santo Spirito in Sassia
RECRUITING
Italy San Giovanni Rotondo IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
Italy Torino A.O.U. Città della Salute e della Scienza
RECRUITING
Israel Afula Ha'Emek Medical Center
RECRUITING
Israel Be'er Ya'akov Shamir Medical Center (Assaf Harofeh)
RECRUITING
Israel Hadera Hillel Yaffe Medical Center
RECRUITING
Israel Haifa, H Bnai Zion Medical Center
RECRUITING
Israel Haifa, H Carmel Medical Center
RECRUITING
Israel Haifa, H Rambam Medical Center
RECRUITING
Israel Jerusalem Shaare Zedek Medical Center
RECRUITING
Israel Nahariya Galilee Medical Center
RECRUITING
Israel Petah Tikva Beilinson medical center
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Safed Ziv Medical Center
COMPLETED
Israel Tel Aviv Sourasky (Ichilov) Medical Center
RECRUITING
Greece Athens Attica Alexandra General Hospital of Athens
RECRUITING
Greece Thessaloniki Anticancer Hospital of Thessaloniki Theageneio
RECRUITING
Greece Thessalonikis G Papanikolaou Hospital of Thessaloniki
RECRUITING
Germany Berlin, BE Charite Campus Benjamin Franklin
RECRUITING
Germany Hamburg, HH Asklepios Klinik Altona
RECRUITING
Germany Heidelberg, BW Universitaetsklinikum Heidelberg
RECRUITING
Germany Koeln Universitaetsklinikum Koelnt
RECRUITING
Germany Leipzig Universitaetsklinikum Leipzig
RECRUITING
Germany Mainz, RP Universitätsmedizin der Johannes Gutenberg Universität
COMPLETED
Germany Wuerzburg Universitaetsklinikum Wuerzburg
RECRUITING
France Creteil APHP - Hopital Henri Mondor
RECRUITING
France Dijon CHU Dijon
RECRUITING
France Lyon Centre Leon Berard
RECRUITING
France Montpellier Cedex 5 CHU de Montpellier - Hopital Saint-Eloi
RECRUITING
France Nantes CHU de Nantes hotel Dieu
RECRUITING
France Nice N/a CHU HOPITAL DE L'ARCHET - Hematology
RECRUITING
France Paris Cedex 12 CHU Hopital Saint Antoine
RECRUITING
France Pessac CHRU - Hôpital du Haut Lévêque - Centre François Magendie
RECRUITING
France TOULOUSE Cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole
RECRUITING
Czechia Brno Fakultni nemocnice Brno
COMPLETED
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Olomouc Fakultní nemocnice Olomouc
COMPLETED
Czechia Ostrava - Poruba Fakultni nemocnice Ostrava
RECRUITING
Czechia Praha 10 Fakultni nemocnice Kralovske Vinohrady
RECRUITING
Czechia Praha 2 Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
RECRUITING
China Beijing, 11 Beijing Chaoyang Hospital
RECRUITING
China Beijing, 11 Peking Union Medical College Hospital
RECRUITING
China Beijing, 11 Peking University First Hospital
RECRUITING
China ChangSha The second Xiangya Hospital of Central South University
RECRUITING
China Changchun The First Hospital of Jilin University
RECRUITING
China Chengdu Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
RECRUITING
China Fuzhou Fujian Medical University Union Hospital
RECRUITING
China Guangzhou Guangdong Provincial People's Hospital
RECRUITING
China Guangzhou Sun Yat-Sen University Cancer Center
RECRUITING
China Hangzhou The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING
China Nanjing Nanjing Drum Tower Hospital
RECRUITING
China Shanghai, 31 Shanghai Fourth People s Hospital
RECRUITING
China Shanghai, 31 Tongji Hospital of Tongji University
RECRUITING
China Shenzhen Peking University Shenzhen Hospital
RECRUITING
China Su Zhou First Affiliated Hospital SooChow University
RECRUITING
China Tianjin, 12 Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
RECRUITING
China Tianjin, 12 Tianjin cancer hospital
RECRUITING
China Wuhan Tongji Hospital, Tongji Medical College of HUST
RECRUITING
China Zhengzhou Henan Cancer Hospital
RECRUITING
Brazil Barretos, SP Fundacao Pio XII
RECRUITING
Brazil Belo Horizonte, MG Santa Casa de Misericordia de Belo Horizonte
RECRUITING
Brazil Brasilia, DF Hospitais Integradaos da Gavea S/A - DF Star
RECRUITING
Brazil Caxias do Sul, RS Fundacao Universidade de Caxias do Sul
RECRUITING
Brazil Curitiba, PR Liga Paranaense de Combate ao Cancer
RECRUITING
Brazil Florianopolis, SC Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
RECRUITING
Brazil Natal, RN Liga Norte Riograndense Contra O Cancer
RECRUITING
Brazil Porto Alegre, RS Irmandade Santa Casa de Misericordia de Porto Alegre
RECRUITING
Brazil Ribeirão Preto, SP Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
RECRUITING
Brazil Rio de Janeiro, RJ Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
RECRUITING
Brazil Salvador, BA Hospital Sao Rafael
RECRUITING
Brazil Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
Brazil Sao Paulo, SP Hospital Paulistano
RECRUITING
Brazil Sao Paulo, SP Instituto D Or de Pesquisa e Ensino (IDOR)
RECRUITING
Brazil São Paulo, SP Clinica Sao Germano
RECRUITING
Brazil São Paulo, SP Real e Benemerita Associacao Portuguesa de Beneficencia
RECRUITING
Brazil São Paulo, SP Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
RECRUITING
Belgium Brussel, BRU UZ Brussel
ACTIVE_NOT_RECRUITING
Belgium Edegem UZA
ACTIVE_NOT_RECRUITING
Belgium Hasselt, VLI Virga Jessa Ziekenhuis
COMPLETED
Belgium Liège CHC MontLegia
ACTIVE_NOT_RECRUITING
Belgium Ottignies Clinique Saint Pierre
ACTIVE_NOT_RECRUITING
Belgium Yvoir, WNA UCL Mont Godinne
RECRUITING
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