Badanie porównujące Talquetamab plus pomalidomid, Talquetamab plus teclistamab i elotuzumab, pomalidomid i deksametazon lub pomalidomid, bortezomib i deksametazon u pacjentów z nawrotowym lub opornym na leczenie szpiczakiem, którzy otrzymali przeciwciało anty-CD38 i lenalidomid (MonumenTAL-6)
Randomizowane badanie III fazy porównujące talquetamab w skojarzeniu z pomalidomidem (Tal-P), talquetamab w skojarzeniu z teklistamabem (Tal-Tec) oraz wybrany przez badacza elotuzumab, pomalidomid i deksametazon (EPd) lub pomalidomid, bortezomib i deksametazon ( PVd) u uczestników chorych na szpiczaka nawrotowego lub opornego na leczenie, którzy otrzymali wcześniej od 1 do 4 linii leczenia, w tym przeciwciała anty-CD38 i lenalidomid
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Riyadh, Arabia Saudyjska, 11564
- King Faisal Specialist Hospital & Research Center
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Riyadh, Arabia Saudyjska, 12231
- King Fahad Medical City
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Riyadh, Arabia Saudyjska, 11481
- King Abdullah International Medical Research Center (KAIMRC)
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Buenos Aires, Argentyna, C1280AEB
- Hospital Britanico de Buenos Aires
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Buenos Aires, Argentyna, C1114AAN
- Fundaleu
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CABA, Argentyna, C1118AAT
- Hospital Aleman
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Box Hill, Australia, 3128
- Box Hill Hospital
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Darlinghurst, Australia, 2010
- St Vincents Hospital
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Fitzroy, Australia, 3065
- St Vincents Hospital Melbourne
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Southport, Australia, 4215
- Gold Coast University Hospital
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West Perth, Australia, 6005
- Perth Blood Institute
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Wollongong, Australia, 2500
- Wollongong Hospital
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Salzburg, Austria, 05020
- LKH - Universitätsklinikum der PMU Salzburg
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Vienna, Austria, 1160
- Klinik Ottakring
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Vienna, Austria, A-1090
- Medical University Vienna MUV
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Charleroi, Belgia, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Genk, Belgia, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgia, 9000
- Ghent University Hospital
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Sint-Niklaas, Belgia, 9100
- AZ Nikolaas - Campus Sint-Niklaas Moerland
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Belo Horizonte, Brazylia, 30110-022
- Cetus Oncologia
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Brasília, Brazylia, 70390 700
- IDOR - Regional Brasilia
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Caxias do Sul, Brazylia, 95070 560
- Fundacao Universidade de Caxias do Sul
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Curitiba, Brazylia, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Porto Alegre, Brazylia, 90035-903
- Hospital De Clinicas De Porto Alegre
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Recife, Brazylia, 50070-480
- IDOR - Regional Pernambuco
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Rio de Janeiro, Brazylia, 22793-080
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brazylia, 41253-190
- IDOR - Regional Bahia
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São José do Rio Preto, Brazylia, 15090-000
- Funfarme Sjrp
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São Paulo, Brazylia, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazylia, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, Brazylia, 01323 001
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brazylia, 01401 002
- IDOR - Regional Sao Paulo
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Beijing, Chiny, 100034
- Peking University First Hospital
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Beijing, Chiny, 100020
- Beijing Chaoyang Hospital
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Beijing, Chiny, 101199
- Peking University People's Hospital
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Changsha, Chiny, 410011
- The Second Xiangya Hospital of Central South Hospital
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Changzhou, Chiny, 213000
- Changzhou No 2 Peoples Hospital
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Chengdu, Chiny, 610032
- Sichuan Provincial Peoples Hospital
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Fuzhou, Chiny, 350005
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, Chiny, 350001
- Fujian Meidical University Union Hospital
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Guangzhou, Chiny, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guangzhou, Chiny, 510060
- Sun Yat Sen University Cancer Center
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Hangzhou, Chiny, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, Chiny, 310003
- First hospital affiliated of Zhejiang Medical university
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Hohhot, Chiny, 010051
- The Affiliated Hospital of Inner Mongolia Medical College
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Jinan, Chiny, 250012
- Qilu Hospital of Shandong University
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Nanchang, Chiny, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, Chiny, 210008
- Nanjing Drum Tower Hospital
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Nanning, Chiny, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Chiny, 200025
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
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Shanghai, Chiny, 200065
- Tongji Hospital of Tongji University
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Shanghai, Chiny, 200434
- Shanghai Fourth People s Hospital
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Shenyang, Chiny, 110055
- Shengjing Hospital Of China Medical University
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Shenzhen, Chiny, 518036
- Peking University Shenzhen Hospital
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Taiyuan, Chiny, 030032
- Shanxi Bethune Hospital
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Tianjin, Chiny, 30060
- Tianjin Medical University Cancer Institute and Hospital
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Wenzhou, Chiny, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Chiny, 430030
- Tongji Hospital, Tongji Medical College of HUST
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Xi'an, Chiny, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xiamen, Chiny, 361026
- The first affiliated hospital of xiamen university
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Brno-Bohunice, Czechy, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Czechy, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Czechy, 779 00
- University Hospital Olomouc
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Ostrava, Czechy, 708 52
- Fakultni Nemocnice Ostrava
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Aarhus, Dania, 8200
- Aarhus University Hospital
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Odense C, Dania, 5000
- Odense University Hospital
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Vejle, Dania, 7100
- Vejle Hospital
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Lille, Francja, 59000
- Hopital Claude Huriez
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Limoges, Francja, 87042
- CHU de Limoges Hopital Dupuytren
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Lyon, Francja, 69002
- Hospices Civils de Lyon HCL
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Marseille, Francja, 13009
- Institut Paoli Calmettes
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Nantes, Francja, 44093
- CHU Nantes
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Paris, Francja, 75010
- Hopital Saint Louis
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Pessac, Francja, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Strasbourg, Francja, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Toulouse, Francja, 31100
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, Francja, 37044
- CHRU Tours Hopital Bretonneau
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Athens, Grecja, 115 28
- Alexandra General Hospital of Athens
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Athens, Grecja, 115 25
- 251 Airforces Hospital
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Thessaloniki, Grecja, 546 39
- Theageneio Cancer Hospital
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Asturias, Hiszpania, 33394
- Hosp. de Cabuenes
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Barcelona, Hiszpania, 08035
- Hosp Univ Vall D Hebron
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Burgos, Hiszpania, 09003
- Hosp. Univ. de Burgos
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Cáceres, Hiszpania, 10003
- Hosp. San Pedro de Alcantara
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Donostia / San Sebastian, Hiszpania, 20014
- Hosp. Univ. Donostia
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Granada, Hiszpania, 18014
- Hosp. Univ. Virgen de Las Nieves
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Lugo, Hiszpania, 27003
- Hosp. Univ. Lucus Augusti
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Madrid, Hiszpania, 28046
- Hosp. Univ. La Paz
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Palma de Mallorca, Hiszpania, 07120
- Hosp. Univ. Son Espases
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Pamplona, Hiszpania, 31008
- Clinica Univ. de Navarra
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Pamplona, Hiszpania, 31008
- Complejo Hosp de Navarra - Hosp de Navarra
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Salamanca, Hiszpania, 37007
- Hosp Clinico Univ de Salamanca
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Santander, Hiszpania, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Hiszpania, 15706
- Hosp. Clinico Univ. de Santiago
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Almere Stad, Holandia, 1315RA
- Flevoziekenhuis
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Eindhoven, Holandia, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Holandia, 3435 CM
- St. Antonius Ziekenhuis Nieuwegein
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The Hague, Holandia, 2545 CH
- Haga ziekenhuis
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Zwolle, Holandia, 8025 AB
- Isala Kliniek
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Gūrgaon, Indie, 122002
- Fortis Memorial Research Institute
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Lucknow, Indie, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Pune, Indie, 411004
- Deenanath Mangeshkar Hospital and Research Centre
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Be’er Ya‘aqov, Izrael, 70300
- Shamir Medical Center Assaf Harofeh
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Haifa, Izrael, 3436212
- Carmel Medical Center
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Petah Tikva, Izrael, 49100
- Rabin Medical center - Petah-Tikva
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Ramat Gan, Izrael, 52621
- Sheba Medical Center
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Tel Aviv, Izrael, 64239
- Tel Aviv Sourasky Medical Center
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Bunkyō City, Japonia, 113 8431
- Juntendo University Hospital
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Fukuoka, Japonia, 814-0180
- Fukuoka University Hospital
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Hamamatsu, Japonia, 431 3192
- Hamamatsu University Hospital
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Kanazawa, Japonia, 920 8641
- Kanazawa University Hospital
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Kyoto, Japonia, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Nagasaki, Japonia, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Narita, Japonia, 286-8523
- Japanese Red Cross Narita Hospital
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Niigata, Japonia, 951-8566
- Niigata Cancer Center Hospital
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Nishinomiya Shi, Japonia, 663 8501
- Hyogo Medical University Hospital
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Osaka, Japonia, 543-8555
- Japanese Red Cross Osaka Hospital
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Sapporo, Japonia, 060-8604
- Sapporo City General Hospital
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Sendai, Japonia, 980 8574
- Tohoku University Hospital
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Shibuya-ku, Japonia, 150-8935
- Japanese Red Cross Medical Center
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Shiwa-gun, Japonia, 028-3695
- Iwate Medical University Hospital
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Suita, Japonia, 565 0871
- The University of Osaka Hospital
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Sunto Gun, Japonia, 411 8777
- Shizuoka Cancer Center
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Tokyo, Japonia, 135 8550
- The Cancer Institute Hospital of JFCR
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Tottori, Japonia, 683-0824
- Tottori University Hospital
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Tsukuba, Japonia, 305 8576
- University of Tsukuba Hospital
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Yokohama, Japonia, 241 8515
- Kanagawa Cancer Center
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z4E6
- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
- Nova Scotia Health Authority
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Ontario
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Hamilton, Ontario, Kanada, L8V5C2
- Juravinski Cancer Centre
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Toronto, Ontario, Kanada, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
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Busan, Korea Południowa, 49201
- Dong-A University Hospital
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Busan, Korea Południowa, 49241
- Pusan National University Hospital
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Jeollanam-do, Korea Południowa, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Korea Południowa, 03080
- Seoul National University Hospital
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Seoul, Korea Południowa, 06351
- Samsung Medical Center
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Seoul, Korea Południowa, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Ulsan, Korea Południowa, 44033
- Ulsan University Hospital
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Guadalajara, Meksyk, 45645
- Centro de Quimioterapia e Investigacion
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Huixquilucan, Meksyk, 52787
- Hematologica Alta Especialidad
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Monterrey, Meksyk, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Augsburg, Niemcy, 86156
- Klinikum Augsburg
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Halle, Niemcy, 06120
- Universitaetsklinikum Halle Saale
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Heidelberg, Niemcy, 69120
- Universitaetsklinikum Heidelberg
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Magdeburg, Niemcy, 39120
- Universitaetsklinikum Magdeburg A.oe.R
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München, Niemcy, 81675
- Klinikum rechts der Isar der TU Muenchen
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Tübingen, Niemcy, 72076
- Universitaetsklinikum Tuebingen
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Würzburg, Niemcy, 97080
- Universitaetsklinikum Wuerzburg
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Biała Podlaska, Polska, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polska, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Kielce, Polska, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Lublin, Polska, 20-090
- Centrum Onkologii Ziemii Lubelskiej
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Szczecin, Polska, 71-252
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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Wroclaw, Polska, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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California
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Clovis, California, Stany Zjednoczone, 93611
- UCSF Fresno
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Santa Monica, California, Stany Zjednoczone, 90404
- UCLA
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06519
- Yale University School Of Medicine
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Delaware
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Newark, Delaware, Stany Zjednoczone, 19713
- Medical Oncology Hematology Consultants, PA
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Florida
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Hollywood, Florida, Stany Zjednoczone, 33021
- Memorial Healthcare System
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Tampa, Florida, Stany Zjednoczone, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Winship Cancer Institute Emory University
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Newnan, Georgia, Stany Zjednoczone, 30265
- City of Hope Cancer Center
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Idaho
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Coeur d'Alene, Idaho, Stany Zjednoczone, 83814
- Kootenai Health
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Illinois
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Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Medical Center
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Iowa
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Waukee, Iowa, Stany Zjednoczone, 50263
- University of Iowa Health Care
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40207
- Norton Cancer Institute
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70808
- Our Lady of the Lake Hospital
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Maryland
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Annapolis, Maryland, Stany Zjednoczone, 21401
- Luminis Health Center for Cancer and Blood Disorders
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Baltimore, Maryland, Stany Zjednoczone, 21201
- University of Maryland School of Medicine
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Baltimore, Maryland, Stany Zjednoczone, 21287
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan
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Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Cancer Institute
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Southfield, Michigan, Stany Zjednoczone, 48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University Of Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic Rochester
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Saint Paul, Minnesota, Stany Zjednoczone, 55101
- Regions Hospital
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68105
- University of Nebraska
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Stany Zjednoczone, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, Stany Zjednoczone, 14263
- Roswell Park Cancer Institute
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New York, New York, Stany Zjednoczone, 10065
- Weill Cornell Medical College
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Syracuse, New York, Stany Zjednoczone, 13210
- SUNY Upstate Medical University
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27705
- Duke University Medical Center
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Ohio
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Canton, Ohio, Stany Zjednoczone, 44718
- Gabrail Cancer Center
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Louis Stokes Cleveland VA Med Ctr
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health And Science University
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Pennsylvania
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Hershey, Pennsylvania, Stany Zjednoczone, 17033
- Penn State Milton S Hershey Medical Ctr
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19107 4215
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- West Penn Hospital
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425-8900
- Medical University of South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29607
- Bon Secours Saint Francis Cancer Center
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern Parkland Hospital
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Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern
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Houston, Texas, Stany Zjednoczone, 77030
- Houston Methodist Neal Cancer Center at Texas Medical Center
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Stany Zjednoczone, 22903
- University of Virginia
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Washington
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Seattle, Washington, Stany Zjednoczone, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Stany Zjednoczone, 98104
- Swedish Cancer Institute
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Tacoma, Washington, Stany Zjednoczone, 98405
- NorthWest Medical Specialties, PLLC
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Wisconsin
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La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Health System
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College Of Wisconsin
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Lund, Szwecja, 221 85
- Skanes universitetssjukhus
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Umeå, Szwecja, 901 85
- Norrlands Universitetssjukhus
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Uppsala, Szwecja, 75185
- Akademiska Sjukhuset
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Varberg, Szwecja, 432 81
- Varberg Hospital
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Ankara, Turcja (Türkiye), 06680
- Liv Hospital Ankara
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Ankara, Turcja (Türkiye), 06620
- Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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Denizli, Turcja (Türkiye), 20070
- Pamukkale Universitesi Tip Fakultesi
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Istanbul, Turcja (Türkiye), 34214
- Medipol University Hospital
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Samsun, Turcja (Türkiye), 55200
- Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
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Budapest, Węgry, 1088
- Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
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Budapest, Węgry, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Debrecen, Węgry, 4032
- Debreceni Egyetem Klinikai Kozpont
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Nyíregyháza, Węgry, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Pécs, Węgry, 7624
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Alessandria, Włochy, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
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Bologna, Włochy, 40138
- A O U Sant Orsola Malpighi
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Brindisi, Włochy, 72100
- Ospedale Perrino
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Catania, Włochy, 95122
- ARNAS Garibaldi P O Nesima
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Genova, Włochy, 16132
- Ospedale Policlinico San Martino IRCCS
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Legnano, Włochy, 20025
- Asst Ovest Milanese - Ospedale Di Legnano
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Milan, Włochy, 20132
- IRCCS Ospedale San Raffaele
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Milan, Włochy, 20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pavia, Włochy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Pescara, Włochy, 65124
- Presidio Ospedaliero Pescara
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Ravenna, Włochy, 48121
- Ospedale S. Maria Delle Croci
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Torino, Włochy, 10126
- Oncologia Medica-Città Della Salute E Della Scienza Di Torino
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Verona, Włochy, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Blackpool, Zjednoczone Królestwo, FY3 8NR
- Blackpool Victoria Hospital
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Cardiff, Zjednoczone Królestwo, CF14 4HY
- University Hospital of Wales
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Dundee, Zjednoczone Królestwo, DD1 9SY
- Ninewells Hospital
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Leeds, Zjednoczone Królestwo, LS9 7TF
- St James University Hospital
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London, Zjednoczone Królestwo, SE5 9RS
- Kings College Hospital
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Nottingham, Zjednoczone Królestwo, NG5 1PB
- Nottingham City Hospital
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Plymouth, Zjednoczone Królestwo, PL6 8DH
- University Hospitals Plymouth NHS Trust
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Portsmouth, Zjednoczone Królestwo, PO6 3LY
- Queen Alexandra Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by 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
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Exclusion Criteria:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of >=140 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Arm A: Talquetamab + Pomalidomide (Tal-P)
Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
Pomalidomide will be administered orally.
Inne nazwy:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Inne nazwy:
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Eksperymentalny: Arm B: Talquetamab + Teclistamab (Tal-Tec)
Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
Teclistamab will be administered as a SC injection.
Inne nazwy:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Inne nazwy:
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Aktywny komparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication. |
Pomalidomide will be administered orally.
Inne nazwy:
Dexamethasone will be administered either orally or intravenously. Elotuzumab will be administered intravenously.
Inne nazwy:
Bortezomib will be administered as a SC injection.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Progression Free Survival (PFS)
Ramy czasowe: Up to 3 years 5 months
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PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. |
Up to 3 years 5 months
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Response Rate (ORR)
Ramy czasowe: Up to 3 years 5 months
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ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria. |
Up to 3 years 5 months
|
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Complete Response (CR) or Better Rate
Ramy czasowe: Up to 3 years 5 months
|
CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria. |
Up to 3 years 5 months
|
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Very Good Partial Response (VGPR) or Better Rate
Ramy czasowe: Up to 3 years 5 months
|
VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria. |
Up to 3 years 5 months
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Minimal Residual Disease (MRD)-negative CR Rate
Ramy czasowe: Up to 3 years 5 months
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MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST). |
Up to 3 years 5 months
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Overall Survival (OS)
Ramy czasowe: Up to 3 years 5 months
|
OS is defined as the time from randomization to the date of participant's death. |
Up to 3 years 5 months
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Progression Free Survival on Next-line Therapy (PFS2)
Ramy czasowe: Up to 3 years 5 months
|
PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first. |
Up to 3 years 5 months
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Time to Next Treatment (TTNT)
Ramy czasowe: Up to 3 years 5 months
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TTNT is defined as the time from randomization to the start of SST. |
Up to 3 years 5 months
|
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Serum Concentration of Talquetamab and Teclistamab
Ramy czasowe: Up to 3 years 5 months
|
Serum concentration of talquetamab and teclistamab will be reported. |
Up to 3 years 5 months
|
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Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
Ramy czasowe: Up to 3 years 5 months
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Number of participants with ADAs to talquetamab and teclistamab will be reported. |
Up to 3 years 5 months
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Ramy czasowe: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. |
Up to 3 years 5 months
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Ramy czasowe: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. |
Up to 3 years 5 months
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Ramy czasowe: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Up to 3 years 5 months
|
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
Ramy czasowe: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe." |
Up to 3 years 5 months
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Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Ramy czasowe: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey. |
Up to 3 years 5 months
|
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
Ramy czasowe: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Ramy czasowe: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems. |
Up to 3 years 5 months
|
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
Ramy czasowe: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
Ramy czasowe: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe." |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Ramy czasowe: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey. |
Up to 3 years 5 months
|
|
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
Ramy czasowe: Up to 3 years 5 months
|
Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems. |
Up to 3 years 5 months
|
|
Number of Participants with Adverse Events (AEs) by Severity
Ramy czasowe: Up to 3 years 5 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 3 years 5 months
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby naczyniowe
- Choroby układu krążenia
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby hematologiczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Nowotwory, komórki plazmatyczne
- Zaburzenia hemostatyczne
- Paraproteinemie
- Zaburzenia białek krwi
- Zaburzenia krwotoczne
- Choroby hemowe i limfatyczne
- Szpiczak mnogi
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Związki policykliczne
- Chemikalia nieorganiczne
- Ciąży
- Ciężarne
- Steroidy
- Związki sterownika
- Sterydy, fluorowane
- Ciąży
- Kwasy boronowe
- Kwasy, niekarboksylowe
- Kwasy
- Związki boru
- Pirazines
- Bortezomib
- Deksametazon
- pomalidomid
- Elotuzumab
- Talquetamab
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 64407564MMY3009
- 64407564MMY3009 (Inny identyfikator: Janssen Research & Development, LLC)
- 2022-502446-27-00 (Identyfikator rejestru: EUCT number)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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