A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9)
Last Updated   April 24, 2024 - 21:08
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
Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.
CONDITIONS
- Relapsed or Refractory Multiple Myeloma
ELIGIBILITY
Inclusion Criteria:
* Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
* Received any prior B cell maturation antigen (BCMA)-directed therapy
* A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
* Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
* Received a live, attenuated vaccine within 4 weeks before randomization
* Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
* Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization
DETAILS
Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.
LOCATIONS
Country (24) | City or Province (195) | Status |
United States | Anchorage, AK Alaska Oncology and Hematology LLC |
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United States | Berkeley, CA Alta Bates Comprehensive Cancer Center |
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United States | Boston, MA Boston University Medical Center |
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United States | Camden, NJ Cooper Health System MD Anderson Cancer Center at Cooper |
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United States | Chesterfield, MO Saint Luke's Hospital - Saint Luke's Cancer Specialists |
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United States | Durham, NC Durham VAMC |
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United States | Farmington, CT University of Connecticut |
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United States | Fort Sam Houston, TX Brooke Army Medical Center |
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United States | Houston, TX Baylor College of Medicine |
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United States | Lancaster, PA Penn Medicine Lancaster General Health |
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United States | Long Beach, CA MemorialCare Long Beach Medical Center |
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United States | Metairie, LA East Jefferson General Hospital Bone Marrow Transport Clinic |
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United States | Miami, FL University of Miami Sylvester Cancer Center |
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United States | New York, NY Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center |
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United States | Orange, CA University of California Irvine |
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United States | Orlando, FL Orlando Health Cancer Institute |
SUSPENDED
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United States | Salt Lake City, UT Utah Cancer Specialists |
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United States | Weston, FL Cleveland Clinic Florida |
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United States | Whittier, CA PIH Health Hospital |
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United Kingdom | Aberdeen Aberdeen Royal Infirmary |
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United Kingdom | Birmingham, WMD University Hospitals Birmingham NHS Foundation Trust |
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United Kingdom | Colchester, ESS Colchester Hospital University NHS |
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United Kingdom | Liverpool, MSY The Clatterbridge Cancer Centre |
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United Kingdom | London Chelsea And Westminster Hospital |
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United Kingdom | London St George's Hospital |
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United Kingdom | Norwich, NFK Norfolk and Norwich University Hospital |
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Turkey | Ankara Ankara Gulhane Training and Research 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 |
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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 | Atakum Ondokuz Mayis University |
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Turkey | Denizli Pamukkale University Medical Faculty |
RECRUITING
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Turkey | Istanbul Medipol University Hospital |
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Sweden | Falun Falu Lasarett Medicinkliniken Falun |
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Sweden | Helsingborg Helsingborgs lasarett |
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Sweden | Uppsala Akademiska Sjukhuset |
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Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
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Spain | Hospitalet de Llobregat, BA Institut Catala d'Oncologia L'Hospitalet |
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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. Infanta Leonor |
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Spain | Madrid, MD Hosp. Univ. Ramon Y Cajal |
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Spain | Murcia, MU Hosp. Gral. Univ. J.M. Morales Meseguer |
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Spain | Oviedo, AS Hospital Universitario Central de Asturias |
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Spain | Palma de Mallorca Hosp. Son Llatzer |
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Spain | Pontevedra, PO Hosp. Montecelo |
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Spain | Pozuelo de Alarcon, MD Hosp. Quiron Madrid Pozuelo |
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Spain | València, VC Hospital Universitari i Politecnic La Fe |
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Portugal | Almada Hosp. Garcia de Orta |
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Portugal | Braga, Braga Ccab - Hosp. de Braga |
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Portugal | Lisbon Champalimaud Foundation Champalimaud Centre |
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Portugal | Porto Instituto Portugues de Oncologia |
RECRUITING
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Portugal | Vila Nova de Gaia Hospital de Vila Nova de Gaia E.P.E. |
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Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
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Poland | Katowice Pratia Onkologia Katowice |
RECRUITING
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Poland | Kielce Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach |
RECRUITING
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Poland | Lublin Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie |
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Netherlands | Amersfoort, UT Meander Medisch Centrum |
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Netherlands | Amsterdam VUMC Amsterdam |
RECRUITING
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Netherlands | Groningen, GR Universitair Medisch Centrum Groningen |
RECRUITING
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Netherlands | Utrecht, UT UMC Utrecht |
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Malaysia | Georgetown Hospital Pulau Pinang |
RECRUITING
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Malaysia | Kota Kinabalu, SB Hospital Queen Elizabeth |
RECRUITING
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Malaysia | Kuala Lumpur University Malaya Medical Centre |
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Malaysia | Subang Jaya, SL Subang Jaya Medical Centre |
RECRUITING
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Japan | Chiba Chiba Cancer Center |
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Japan | Gifu Ogaki Municipal Hospital |
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Japan | Gunma, 10 National Hospital Organization Shibukawa Medical Center |
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Japan | Hirakata, 27 Kansai Medical University Hospital |
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Japan | Hitachi, 08 Hitachi General Hospital |
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Japan | Iruma-gun, 11 Saitama Medical University Hospital |
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Japan | Kamogawa City Kameda General Hospital |
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Japan | Kashiwa National Cancer Center Hospital East |
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Japan | Kurashiki, 33 Kurashiki Central Hospital |
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Japan | Matsuyama, 38 Matsuyama Red Cross Hospital |
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Japan | Nagakute Aichi Medical University Hospital |
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Japan | Nagasaki-Shi, 42 JRC Nagasaki Genbaku Hospital |
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Japan | Niigata, 15 Niigata University Medical And Dental Hospital |
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Japan | Okayama, 33 National Hospital Organization Okayama Medical Center |
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Japan | Osaka, 27 Osaka Metropolitan University Hospital |
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Japan | Sapporo, 01 Hokkaido University Hospital |
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Japan | Tokyo, 13 Juntendo University Hospital |
RECRUITING
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Japan | Tokyo, 13 The Cancer Institute Hospital of JFCR |
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Japan | Yamagata, 06 Yamagata University Hospital |
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Japan | Yamanashi Yamanashi Prefectural Central Hospital |
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Italy | Bologna A O U Sant Orsola Malpighi |
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Italy | Milano Fondazione IRCCS Istituto Nazionale dei Tumori |
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Italy | Palermo Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone |
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Italy | Pisa Ospedale Santa Chiara AO Universitaria Pisana |
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Italy | Reggio Emilia Arcispedale Santa Maria Nuova - IRCCS |
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Italy | Roma Campus Bio Medico di Roma |
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Italy | Siena A O Universitaria Senese Ospedale Santa Maria alle Scotte |
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Italy | Turin A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette |
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Italy | Udine ASUI Santa Maria della Misericordia di Udine |
RECRUITING
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Italy | Varese Ospedale di Circolo e Fondazione Macchi |
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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 | Petah Tikva Rabin Medical Center |
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Israel | Ramat Gan Sheba Medical Center |
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Israel | Tel Aviv-Yafo Tel-Aviv Sourasky Medical Center |
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India | Gurgaon Fortis Memorial Research Institute |
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India | Pune, MH Deenanath Mangeshkar Hospital and Research Centre |
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Greece | Athens Attica Alexandra General Hospital of Athens |
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Greece | Patra Agios Andreas General Hospital of Patra |
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Greece | Thessaloniki G Papanikolaou Hospital of Thessaloniki |
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Germany | Cottbus, BB Carl-Thiem-Klinikum Cottbus gGmbH |
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Germany | Dresden, SN Universitatsklinikum Carl Gustav Carus Dresden |
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Germany | Greifswald, MV Universitätsmedizin Greifswald |
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Germany | Hamburg, HH Asklepios Klinik Altona |
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Germany | Heidelberg, BW Universitaetsklinikum Heidelberg |
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Germany | Marburg, HE Universitaetsklinikum Giessen und Marburg GmbH |
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Germany | Tübingen, BW Universitatsklinikum Tubingen |
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Germany | Ulm, BW Universitatsklinikum Ulm |
RECRUITING
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Germany | Zwickau Heinrich-Braun-Klinikum gGmbH |
RECRUITING
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France | AMIENS cedex 1 CHU Amiens - Hopital Sud |
RECRUITING
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France | Caen cedex 9 Hôpital Côte de Nacre |
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France | Grenoble CHU Grenoble |
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France | Le Mans Centre Hospitalier du Mans |
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France | Lille Hopital Saint Vincent de Paul |
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France | Montpellier CHU de Montpellier, Hopital Saint-Eloi |
RECRUITING
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France | Nantes Cedex 1 CHU Nantes |
RECRUITING
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France | Paris Hopital Saint-Antoine |
RECRUITING
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France | Paris Hopital de la Pitie Salpetriere |
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France | Paris Hôpital Necker Enfants Malades |
RECRUITING
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France | Toulouse Institut Universitaire du Cancer Toulouse Oncopole |
RECRUITING
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France | Vandœuvre-lès-Nancy CHU de Nancy - Hopital de Brabois |
RECRUITING
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Denmark | Aalborg Aalborg University Hospital |
RECRUITING
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Denmark | Aarhus Aarhus University Hospital |
RECRUITING
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Denmark | Copenhagen Rigshospitalet |
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Denmark | Herning Regionshospitalet Godstrup |
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Denmark | Odense C Odense Universitetshospital |
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Denmark | Vejle Vejle Sygehus |
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Czechia | Brno Fakultni nemocnice Brno |
RECRUITING
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Czechia | Olomouc Fakultní nemocnice Olomouc |
RECRUITING
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Czechia | Ostrava - Poruba Fakultni nemocnice Ostrava |
RECRUITING
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Czechia | Praha 2 Vseobecna fakultni nemocnice v Praze |
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China | Beijing, 11 BeiJing JiShuiTan Hospital |
RECRUITING
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China | Beijing, 11 Beijing Chaoyang Hospital |
RECRUITING
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China | Changchun The First Bethune Hospital of Jilin University |
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China | Changsha The Third Xiangya Hospital, Central South University |
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China | Chengdu Sichuan Provincial Peoples Hospital |
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China | Chongqing, 97 Chongqing University Cancer Hospital |
RECRUITING
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China | Fu Zhou Fujian Meidical University Union Hospital |
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China | Guangzhou Sun Yat -Sen University Cancer Center |
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China | Hangzhou First affiliated Hospital of Zhejiang University |
RECRUITING
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China | Harbin, 23 Harbin medical university cancer hospital |
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China | Nanchang The First Affiliated Hospital of NanChang University |
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China | Nanjing Nanjing Drum Tower Hospital |
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China | Nanning First Affiliated Hospital of Guangxi Medical University |
RECRUITING
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China | Shanghai, 31 Shanghai Fourth People s Hospital |
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China | Shenyang Shengjing Hospital of China Medical University |
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China | Shenzhen Shenzhen 2nd People's Hospital |
RECRUITING
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China | Tian Jin, 12 Institute of Hematology and Blood Diseases Hospital |
RECRUITING
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China | Tianjin, 12 Tianjin Medical University Cancer Institute and Hospital |
RECRUITING
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China | Wenzhou The First Affiliated Hospital of Wenzhou Medical University |
RECRUITING
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China | Wuhan Wuhan Union Hospital |
RECRUITING
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China | Wuxi Wuxi People s Hospital |
RECRUITING
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China | Xi'an The Second Affiliated Hospital of Xi'an Jiaotong University |
RECRUITING
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China | Zhengzhou Henan Cancer Hospital |
RECRUITING
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Canada | Brampton, ON Brampton Civic Hospital |
RECRUITING
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Canada | Calgary, AB Tom Baker Cancer Centre |
RECRUITING
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Canada | Montreal, QC CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont |
RECRUITING
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Canada | Oshawa, ON Lakeridge Health Oshawa |
RECRUITING
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Canada | Saint John, NB Saint John Regional Hospital |
RECRUITING
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Brazil | Brasilia, DF Hospitais Integradaos da Gavea S/A - DF Star |
RECRUITING
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Brazil | Caxias do Sul, RS Fundacao Universidade de Caxias do Sul |
RECRUITING
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Brazil | Curitiba, PR Liga Paranaense de Combate ao Cancer |
RECRUITING
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Brazil | Joinville, SC Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia |
RECRUITING
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Brazil | Natal, RN Liga Norte Riograndense Contra O Cancer |
RECRUITING
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Brazil | Niteroi, RJ Complexo Hospitalar de Niteroi |
RECRUITING
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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 |
RECRUITING
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Brazil | Sao Jose do Rio Preto, SP Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base |
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Brazil | Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center |
RECRUITING
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Brazil | Sao Paulo, SP Instituto D Or de Pesquisa e Ensino (IDOR) |
RECRUITING
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Brazil | Sao Paulo, SP Sociedade Beneficente de Senhoras - Hospital Sírio Libanês |
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Brazil | São Paulo, SP Clinica Sao Germano |
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Brazil | São Paulo, SP Hospital Alemao Oswaldo Cruz |
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Brazil | São Paulo, SP Real e Benemérita Associação Portuguesa de Beneficência |
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Brazil | São Paulo, SP Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein |
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Belgium | Brasschaat Algemeen Ziekenhuis Klina |
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Belgium | Haine-St-Paul, WHT Jolimont |
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Belgium | Kortrijk Az Groeninge |
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Belgium | Leuven Universitair Ziekenhuis Gasthuisberg |
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Belgium | Liege CHR de la Citadelle |
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Austria | Salzburg, SAL LKH - Universitätsklinikum der PMU Salzburg |
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Austria | Vienna Medical University Vienna MUV |
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Australia | Blacktown, NSW Blacktown Hospital |
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Australia | Fitzroy, VIC St. Vincent's Hospital Melbourne |
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Australia | Melbourne, VIC Box Hill Hospital |
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Australia | Murdoch, WA Fiona Stanley Hospital |
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Australia | Nedlands, WA Sir Charles Gairdner Hospital |
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