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
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The 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
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
Country (18) | City or Province (216) | Status |
United States | Ann Arbor, MI University of Michigan Health System |
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United States | Baltimore, MD Johns Hopkins University |
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United States | Boston, MA Boston University Medical Center |
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United States | Boston, MA Massachusetts General |
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United States | Chapel Hill, NC University of North Carolina |
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United States | Charleston, SC Medical University of South Carolina |
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United States | Charlotte, NC Levine Cancer Institute, Carolinas HealthCare System |
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United States | Charlotte, NC Novant Health |
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United States | Charlottesville, VA University of Virginia |
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United States | Chicago, IL University Of Illinois |
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United States | Cleveland, OH University Hospitals Cleveland Medical Center |
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United States | Columbus, OH OhioHealth |
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United States | Columbus, OH The Ohio State University Wexner Medical Center - James Cancer Hospital |
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United States | Hollywood, FL Memorial Healthcare System |
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United States | Houston, TX Houston Methodist Hospital |
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United States | Houston, TX MD Anderson Cancer Center |
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United States | Jackson, MS University of Mississippi Medical Center |
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United States | Little Rock, AR University of Arkansas for Medical Sciences |
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United States | Lubbock, TX Joe Arrington Cancer Research Treatment Center |
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United States | Memphis, TN Baptist Cancer Center |
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United States | Miami, FL University of Miami Health System |
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United States | Minneapolis, MN University Of Minnesota |
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United States | New Brunswick, NJ Rutgers Cancer Institute of New Jersey |
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United States | New Orleans, LA Ochsner Health System |
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United States | New Orleans, LA Tulane University Hospital & Clinics |
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United States | New York, NY NYU Langone Health |
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United States | Norwalk, CT Norwalk Hospital-oncology |
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United States | Philadelphia, PA Thomas Jefferson University |
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United States | Richmond, VA Virginia Commonwealth University - Massey Cancer Center |
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United States | Saint Louis, MO Washington University School of Medicine |
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United States | Salt Lake City, UT Huntsman Cancer Institute |
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United States | Seattle, WA Fred Hutchinson Cancer Research Center |
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United States | Syracuse, NY SUNY Upstate Medical University |
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United States | Tucson, AZ The University of Arizona Cancer Center |
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United States | Washington, DC George Washington University |
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United States | Washington, DC MedStar Georgetown University Hospital |
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United States | Westwood, KS University of Kansas |
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United States | Winston-Salem, NC Novant Health |
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United States | Winston-Salem, NC Wake Forest Baptist Medical Center |
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United States | Worcester, MA University of Massachusetts Medical School |
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United Kingdom | Blackpool Blackpool Victoria Hospital |
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United Kingdom | Dundee Ninewells Hospital & Medical School |
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United Kingdom | London Imperial College Healthcare |
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United Kingdom | Newcastle Upon Tyne Newcastle Freeman Hospital |
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United Kingdom | Nottingham Nottingham City Hospital |
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United Kingdom | Plymouth University Hospitals Plymouth NHS Trust |
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United Kingdom | Sutton Royal Marsden Hospital |
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United Kingdom | Wolverhampton, WMD New Cross Hospital |
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Turkey | Ankara Ankara University Medical Faculty |
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Turkey | Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit |
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Turkey | Ankara Liv Hospital Ankara |
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Turkey | Antalya Antalya Training And Research Hospital |
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Turkey | Istabul Medipol Mega University Hospital |
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Turkey | Istanbul Istanbul University Cerrahpasa Medical Faculty |
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Turkey | Istanbul Istanbul University Istanbul Medical Faculty |
SUSPENDED
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Turkey | Izmir Dokuz Eylul University Medical Faculty |
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Turkey | Samsun On Dokuz Mayıs University Medical Faculty |
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Taiwan | Kaohsiung Kaohsiung Chang Gung Memorial Hospital |
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Taiwan | Kaohsiung Kaohsiung Medical University Chung-Ho Memorial Hospital |
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Taiwan | Taichung City China Medical University Hospital |
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Taiwan | Tainan National Cheng Kung University Hospital |
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Taiwan | Taipei National Taiwan University Hospital |
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Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
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Spain | Barcelona, BA Hosp. Clinic de Barcelona |
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Spain | Barcelona, BA Hosp. Univ. Vall D Hebron |
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Spain | Barcelona, BA Hosp. de La Santa Creu I Sant Pau |
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Spain | El Palmar, Murcia, MU Hosp. Univ. Virgen de La Arrixaca |
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Spain | Jerez de la Frontera Hosp. de Jerez de La Frontera |
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Spain | Leon Hosp. de Leon |
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Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
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Spain | Madrid, MD Hosp. Univ. Hm Sanchinarro |
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Spain | Madrid, MD Hosp. Univ. Ramon Y Cajal |
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Spain | Madrid, MD Hosp. Univ. de La Princesa |
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Spain | Malaga Hosp. Virgen de La Victoria |
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Spain | Pamplona Clinica Univ. de Navarra |
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Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
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Spain | San Cristóbal de La Laguna Hosp. Univ. de Canarias |
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Spain | Valencia, VC Hosp. Univ. Dr. Peset |
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South Korea | Busan Dong-A University Hospital |
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South Korea | Gyeonggi-do, 41 National Cancer Center |
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South Korea | Incheon Gachon University Gil Medical Center |
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South Korea | Jeollanam-do, 46 Chonnam National University Hwasun Hospital |
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South Korea | Jeonju-si, 45 Jeonbuk National University Hospital |
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South Korea | Seoul Asan Medical Center |
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South Korea | Seoul Samsung Medical Center |
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South Korea | Seoul Seoul National University Hospital |
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South Korea | Seoul Severance Hospital, Yonsei University Health System |
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South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
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Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
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Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
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Poland | Katowice Pratia Onkologia Katowice |
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Poland | Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach |
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Poland | Krakow Szpital Uniwersytecki w Krakowie |
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Poland | Lublin Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli |
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Poland | Olsztyn Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii |
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Poland | Szczecin Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie |
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Poland | Torun Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu |
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Poland | Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy |
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Poland | Wroclaw Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu |
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Netherlands | Dordrecht Albert Schweitzer ziekenhuis-lokatie Dordwijk |
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Netherlands | Eindhoven Maxima Medisch Centrum |
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Netherlands | Rotterdam Erasmus MC |
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Japan | Bunkyo-Ku, 13 Tokyo Medical and Dental University Hospital |
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Japan | Chiba Chiba Cancer Center |
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Japan | Fukuoka Fukuoka University Hospital |
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Japan | Gifu Ogaki Municipal Hospital |
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Japan | Gunma, 10 Gunma University Hospital |
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Japan | Hirakata, 27 Kansai Medical University Hospital |
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Japan | Hyogo, 28 Japanese Red Cross Society Himeji Hospital |
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Japan | Hyôgo, 28 Hyogo Medical University Hospital |
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Japan | Kamakura-shi, 14 Shonan Kamakura General Hospital |
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Japan | Kashiwa National Cancer Center Hospital East |
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Japan | Koshigaya, 11 Dokkyo Medical University Saitama Medical Center |
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Japan | Kumamoto, 43 Kumamoto University Hospital |
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Japan | Kyoto, 26 Kyoto Kuramaguchi Medical Center |
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Japan | Matsumoto, 20 National Hospital Organization Matsumoto Medical Center |
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Japan | Niigata, 15 Niigata Cancer Center Hospital |
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Japan | Otake Hiroshima West Medical Center |
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Japan | Sapporo-shi, 01 Hokkaido University Hospital |
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Japan | Sendai, 04 Tohoku University Hospital |
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Japan | Shiwa-gun, 03 Iwate Medical University Hospital |
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Japan | Suita-shi, 27 Osaka University Hospital |
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Japan | Tokyo, 13 The Cancer Institute Hospital of JFCR |
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Italy | Ancona A.O. Universitaria Ospedali Riuniti di Ancona |
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Italy | Bari Policlinico di Bari |
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Italy | Bologna Azienda Ospedaliera Policlinico S. Orsola-Malpighi |
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Italy | Brescia Azienda Ospedaliera Spedali Civili di Brescia |
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Italy | Catania PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania |
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Italy | Milano ASST Grande Ospedale Metropolitano Niguarda |
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Italy | Milano Fondazione IRCCS Istituto Nazionale dei Tumori |
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Italy | Padova Azienda Ospedaliera Universitaria di Padova |
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Italy | Palermo Ospedale Villa Sofia-Cervello |
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Italy | Pavia Fondazione IRCCS Policlinico San Matteo |
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Italy | Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS |
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Italy | Roma Presidio Ospedaliero Santo Spirito in Sassia |
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Italy | San Giovanni Rotondo IRCCS Ospedale Casa Sollievo della Sofferenza |
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Italy | Torino A.O.U. Città della Salute e della Scienza |
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Israel | Afula Ha'Emek Medical Center |
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Israel | Be'er Ya'akov Shamir Medical Center (Assaf Harofeh) |
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Israel | Hadera Hillel Yaffe Medical Center |
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Israel | Haifa, H Bnai Zion Medical Center |
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Israel | Haifa, H Carmel Medical Center |
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Israel | Haifa, H Rambam Medical Center |
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Israel | Jerusalem Shaare Zedek Medical Center |
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Israel | Nahariya Galilee Medical Center |
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Israel | Petah Tikva Beilinson medical center |
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Israel | Ramat Gan Sheba Medical Center |
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Israel | Safed Ziv Medical Center |
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Israel | Tel Aviv Sourasky (Ichilov) Medical Center |
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Greece | Athens Attica Alexandra General Hospital of Athens |
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Greece | Thessaloniki Anticancer Hospital of Thessaloniki Theageneio |
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Greece | Thessalonikis G Papanikolaou Hospital of Thessaloniki |
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Germany | Berlin, BE Charite Campus Benjamin Franklin |
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Germany | Hamburg, HH Asklepios Klinik Altona |
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Germany | Heidelberg, BW Universitaetsklinikum Heidelberg |
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Germany | Koeln Universitaetsklinikum Koelnt |
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Germany | Leipzig Universitaetsklinikum Leipzig |
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Germany | Mainz, RP Universitätsmedizin der Johannes Gutenberg Universität |
COMPLETED
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Germany | Wuerzburg Universitaetsklinikum Wuerzburg |
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France | Creteil APHP - Hopital Henri Mondor |
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France | Dijon CHU Dijon |
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France | Lyon Centre Leon Berard |
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France | Montpellier Cedex 5 CHU de Montpellier - Hopital Saint-Eloi |
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France | Nantes CHU de Nantes hotel Dieu |
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France | Nice N/a CHU HOPITAL DE L'ARCHET - Hematology |
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France | Paris Cedex 12 CHU Hopital Saint Antoine |
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France | Pessac CHRU - Hôpital du Haut Lévêque - Centre François Magendie |
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France | TOULOUSE Cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole |
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Czechia | Brno Fakultni nemocnice Brno |
COMPLETED
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Czechia | Hradec Kralove Fakultni nemocnice Hradec Kralove |
RECRUITING
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Czechia | Olomouc Fakultní nemocnice Olomouc |
COMPLETED
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Czechia | Ostrava - Poruba Fakultni nemocnice Ostrava |
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Czechia | Praha 10 Fakultni nemocnice Kralovske Vinohrady |
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Czechia | Praha 2 Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie |
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China | Beijing, 11 Beijing Chaoyang Hospital |
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China | Beijing, 11 Peking Union Medical College Hospital |
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China | Beijing, 11 Peking University First Hospital |
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China | ChangSha The second Xiangya Hospital of Central South University |
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China | Changchun The First Hospital of Jilin University |
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China | Chengdu Sichuan Academy of Medical Science Sichuan Provincial People's Hospital |
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China | Fuzhou Fujian Medical University Union Hospital |
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China | Guangzhou Guangdong Provincial People's Hospital |
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China | Guangzhou Sun Yat-Sen University Cancer Center |
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China | Hangzhou The First Affiliated Hospital Zhejiang University College of Medicine |
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China | Nanjing Nanjing Drum Tower Hospital |
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China | Shanghai, 31 Shanghai Fourth People s Hospital |
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China | Shanghai, 31 Tongji Hospital of Tongji University |
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China | Shenzhen Peking University Shenzhen Hospital |
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China | Su Zhou First Affiliated Hospital SooChow University |
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China | Tianjin, 12 Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science |
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China | Tianjin, 12 Tianjin cancer hospital |
RECRUITING
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China | Wuhan Tongji Hospital, Tongji Medical College of HUST |
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China | Zhengzhou Henan Cancer Hospital |
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Brazil | Barretos, SP Fundacao Pio XII |
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Brazil | Belo Horizonte, MG Santa Casa de Misericordia de Belo Horizonte |
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Brazil | Brasilia, DF Hospitais Integradaos da Gavea S/A - DF Star |
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Brazil | Caxias do Sul, RS Fundacao Universidade de Caxias do Sul |
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Brazil | Curitiba, PR Liga Paranaense de Combate ao Cancer |
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Brazil | Florianopolis, SC Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN |
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Brazil | Natal, RN Liga Norte Riograndense Contra O Cancer |
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Brazil | Porto Alegre, RS Irmandade Santa Casa de Misericordia de Porto Alegre |
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Brazil | Ribeirão Preto, SP Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP |
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Brazil | Rio de Janeiro, RJ Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) |
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Brazil | Salvador, BA Hospital Sao Rafael |
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Brazil | Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center |
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Brazil | Sao Paulo, SP Hospital Paulistano |
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Brazil | Sao Paulo, SP Instituto D Or de Pesquisa e Ensino (IDOR) |
RECRUITING
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Brazil | São Paulo, SP Clinica Sao Germano |
RECRUITING
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Brazil | São Paulo, SP Real e Benemerita Associacao Portuguesa de Beneficencia |
RECRUITING
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Brazil | São Paulo, SP Sociedade Beneficente de Senhoras - Hospital Sírio Libanês |
RECRUITING
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Belgium | Brussel, BRU UZ Brussel |
ACTIVE_NOT_RECRUITING
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Belgium | Edegem UZA |
ACTIVE_NOT_RECRUITING
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Belgium | Hasselt, VLI Virga Jessa Ziekenhuis |
COMPLETED
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Belgium | Liège CHC MontLegia |
ACTIVE_NOT_RECRUITING
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Belgium | Ottignies Clinique Saint Pierre |
ACTIVE_NOT_RECRUITING
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Belgium | Yvoir, WNA UCL Mont Godinne |
RECRUITING
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