Studie porovnávající talquetamab plus pomalidomid, talquetamab plus teklistamab a elotuzumab, pomalidomid a dexamethason nebo pomalidomid, bortezomib a dexamethason u účastníků s relapsem nebo refrakterním myelomem, kteří dostali protilátku anti-CD38 a lenalidomid (MonumenTAL-6)
Randomizovaná studie fáze 3 porovnávající talquetamab v kombinaci s pomalidomidem (Tal-P), talquetamab v kombinaci s teklistamabem (Tal-Tec) a výběr zkoušejícího buď elotuzumab, pomalidomid a dexamethason (EPd) nebo pomalidomid, pomalidomid a bortexamet PVd) u účastníků s relapsem nebo refrakterním myelomem, kteří podstoupili 1 až 4 předchozí linie terapie včetně protilátky anti-CD38 a lenalidomidu
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).
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
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Buenos Aires, Argentina, C1114AAN
- Fundaleu
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CABA, Argentina, C1118AAT
- Hospital Aleman
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Adelaide, Austrálie, 5000
- Royal Adelaide Hospital
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Box Hill, Austrálie, 3128
- Box Hill Hospital
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Darlinghurst, Austrálie, 2010
- St Vincents Hospital
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Fitzroy, Austrálie, 3065
- St Vincents Hospital Melbourne
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Southport, Austrálie, 4215
- Gold Coast University Hospital
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West Perth, Austrálie, 6005
- Perth Blood Institute
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Wollongong, Austrálie, 2500
- Wollongong Hospital
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Charleroi, Belgie, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Genk, Belgie, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Belgie, 9000
- Ghent University Hospital
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Sint-Niklaas, Belgie, 9100
- AZ Nikolaas - Campus Sint-Niklaas Moerland
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Belo Horizonte, Brazílie, 30110-022
- Cetus Oncologia
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Brasília, Brazílie, 70390 700
- IDOR - Regional Brasilia
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Caxias do Sul, Brazílie, 95070 560
- Fundacao Universidade de Caxias do Sul
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Curitiba, Brazílie, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Porto Alegre, Brazílie, 90035-903
- Hospital De Clinicas De Porto Alegre
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Recife, Brazílie, 50070-480
- IDOR - Regional Pernambuco
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Rio de Janeiro, Brazílie, 22793-080
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brazílie, 41253-190
- IDOR - Regional Bahia
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São José do Rio Preto, Brazílie, 15090-000
- Funfarme Sjrp
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São Paulo, Brazílie, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazílie, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, Brazílie, 01323 001
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brazílie, 01401 002
- IDOR - Regional Sao Paulo
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Aarhus, Dánsko, 8200
- Aarhus University Hospital
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Odense C, Dánsko, 5000
- Odense University Hospital
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Vejle, Dánsko, 7100
- Vejle Hospital
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Lille, Francie, 59000
- Hopital Claude Huriez
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Limoges, Francie, 87042
- CHU de Limoges Hopital Dupuytren
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Lyon, Francie, 69002
- Hospices Civils de Lyon HCL
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Marseille, Francie, 13009
- Institut Paoli Calmettes
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Nantes, Francie, 44093
- CHU Nantes
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Paris, Francie, 75010
- Hopital Saint Louis
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Pessac, Francie, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Strasbourg, Francie, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Toulouse, Francie, 31100
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, Francie, 37044
- CHRU Tours Hopital Bretonneau
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Almere Stad, Holandsko, 1315RA
- Flevoziekenhuis
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Eindhoven, Holandsko, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Holandsko, 3435 CM
- St. Antonius Ziekenhuis Nieuwegein
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The Hague, Holandsko, 2545 CH
- Haga ziekenhuis
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Zwolle, Holandsko, 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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Alessandria, Itálie, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
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Bologna, Itálie, 40138
- A O U Sant Orsola Malpighi
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Brindisi, Itálie, 72100
- Ospedale Perrino
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Catania, Itálie, 95122
- ARNAS Garibaldi P O Nesima
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Genova, Itálie, 16132
- Ospedale Policlinico San Martino IRCCS
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Legnano, Itálie, 20025
- Asst Ovest Milanese - Ospedale Di Legnano
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Milan, Itálie, 20132
- IRCCS Ospedale San Raffaele
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Milan, Itálie, 20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pavia, Itálie, 27100
- Fondazione IRCCS Policlinico San Matteo
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Pescara, Itálie, 65124
- Presidio Ospedaliero Pescara
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Ravenna, Itálie, 48121
- Ospedale S. Maria Delle Croci
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Torino, Itálie, 10126
- Oncologia Medica-Città Della Salute E Della Scienza Di Torino
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Verona, Itálie, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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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, Japonsko, 113 8431
- Juntendo University Hospital
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Fukuoka, Japonsko, 814-0180
- Fukuoka University Hospital
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Hamamatsu, Japonsko, 431 3192
- Hamamatsu University Hospital
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Kanazawa, Japonsko, 920 8641
- Kanazawa University Hospital
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Kyoto, Japonsko, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Nagasaki, Japonsko, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Narita, Japonsko, 286-8523
- Japanese Red Cross Narita Hospital
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Niigata, Japonsko, 951-8566
- Niigata Cancer Center Hospital
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Nishinomiya Shi, Japonsko, 663 8501
- Hyogo Medical University Hospital
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Osaka, Japonsko, 543-8555
- Japanese Red Cross Osaka Hospital
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Sapporo, Japonsko, 060-8604
- Sapporo City General Hospital
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Sendai, Japonsko, 980 8574
- Tohoku University Hospital
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Shibuya-ku, Japonsko, 150-8935
- Japanese Red Cross Medical Center
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Shiwa-gun, Japonsko, 028-3695
- Iwate Medical University Hospital
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Suita, Japonsko, 565 0871
- The University of Osaka Hospital
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Sunto Gun, Japonsko, 411 8777
- Shizuoka Cancer Center
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Tokyo, Japonsko, 135 8550
- The Cancer Institute Hospital of JFCR
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Tottori, Japonsko, 683-0824
- Tottori University Hospital
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Tsukuba, Japonsko, 305 8576
- University of Tsukuba Hospital
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Yokohama, Japonsko, 241 8515
- Kanagawa Cancer Center
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Busan, Jižní Korea, 49201
- Dong-A University Hospital
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Busan, Jižní Korea, 49241
- Pusan National University Hospital
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Jeollanam-do, Jižní Korea, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Jižní Korea, 03080
- Seoul National University Hospital
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Seoul, Jižní Korea, 06351
- Samsung Medical Center
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Seoul, Jižní Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Ulsan, Jižní Korea, 44033
- Ulsan University Hospital
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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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Budapest, Maďarsko, 1088
- Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
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Budapest, Maďarsko, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Debrecen, Maďarsko, 4032
- Debreceni Egyetem Klinikai Kozpont
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Nyíregyháza, Maďarsko, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Pécs, Maďarsko, 7624
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Guadalajara, Mexiko, 45645
- Centro de Quimioterapia e Investigacion
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Huixquilucan, Mexiko, 52787
- Hematologica Alta Especialidad
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Monterrey, Mexiko, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Augsburg, Německo, 86156
- Klinikum Augsburg
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Halle, Německo, 06120
- Universitaetsklinikum Halle Saale
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Heidelberg, Německo, 69120
- Universitaetsklinikum Heidelberg
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Magdeburg, Německo, 39120
- Universitaetsklinikum Magdeburg A.oe.R
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München, Německo, 81675
- Klinikum rechts der Isar der TU Muenchen
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Tübingen, Německo, 72076
- Universitaetsklinikum Tuebingen
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Würzburg, Německo, 97080
- Universitaetsklinikum Wuerzburg
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Biała Podlaska, Polsko, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polsko, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Kielce, Polsko, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Lublin, Polsko, 20-090
- Centrum Onkologii Ziemii Lubelskiej
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Szczecin, Polsko, 71-252
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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Wroclaw, Polsko, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Salzburg, Rakousko, 05020
- LKH - Universitätsklinikum der PMU Salzburg
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Vienna, Rakousko, 1160
- Klinik Ottakring
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Vienna, Rakousko, A-1090
- Medical University Vienna MUV
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Riyadh, Saudská arábie, 11564
- King Faisal Specialist Hospital & Research Center
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Riyadh, Saudská arábie, 12231
- King Fahad Medical City
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Riyadh, Saudská arábie, 11481
- King Abdullah International Medical Research Center (KAIMRC)
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Blackpool, Spojené království, FY3 8NR
- Blackpool Victoria Hospital
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Cardiff, Spojené království, CF14 4HY
- University Hospital of Wales
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Dundee, Spojené království, DD1 9SY
- Ninewells Hospital
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Leeds, Spojené království, LS9 7TF
- St James University Hospital
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London, Spojené království, SE5 9RS
- Kings College Hospital
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Nottingham, Spojené království, NG5 1PB
- Nottingham City Hospital
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Plymouth, Spojené království, PL6 8DH
- University Hospitals Plymouth NHS Trust
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Portsmouth, Spojené království, PO6 3LY
- Queen Alexandra Hospital
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California
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Clovis, California, Spojené státy, 93611
- UCSF Fresno
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Santa Monica, California, Spojené státy, 90404
- UCLA
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Connecticut
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New Haven, Connecticut, Spojené státy, 06519
- Yale University School Of Medicine
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Delaware
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Newark, Delaware, Spojené státy, 19713
- Medical Oncology Hematology Consultants, PA
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Florida
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Hollywood, Florida, Spojené státy, 33021
- Memorial Healthcare System
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Tampa, Florida, Spojené státy, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Winship Cancer Institute Emory University
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Newnan, Georgia, Spojené státy, 30265
- City of Hope Cancer Center
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Idaho
-
Coeur d'Alene, Idaho, Spojené státy, 83814
- Kootenai Health
-
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Illinois
-
Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center
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Iowa
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Waukee, Iowa, Spojené státy, 50263
- University of Iowa Health Care
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Kentucky
-
Louisville, Kentucky, Spojené státy, 40207
- Norton Cancer Institute
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Louisiana
-
Baton Rouge, Louisiana, Spojené státy, 70808
- Our Lady of the Lake Hospital
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Maryland
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Annapolis, Maryland, Spojené státy, 21401
- Luminis Health Center for Cancer and Blood Disorders
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Baltimore, Maryland, Spojené státy, 21201
- University of Maryland School of Medicine
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Baltimore, Maryland, Spojené státy, 21287
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Cancer Institute
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Southfield, Michigan, Spojené státy, 48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- University Of Minnesota
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Rochester
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Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
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Nebraska
-
Omaha, Nebraska, Spojené státy, 68105
- University of Nebraska
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New Hampshire
-
Lebanon, New Hampshire, Spojené státy, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, Spojené státy, 14263
- Roswell Park Cancer Institute
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New York, New York, Spojené státy, 10065
- Weill Cornell Medical College
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Syracuse, New York, Spojené státy, 13210
- SUNY Upstate Medical University
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North Carolina
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Durham, North Carolina, Spojené státy, 27705
- Duke University Medical Center
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Ohio
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Canton, Ohio, Spojené státy, 44718
- Gabrail Cancer Center
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
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Cleveland, Ohio, Spojené státy, 44106
- Louis Stokes Cleveland VA Med Ctr
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Oregon Health And Science University
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Penn State Milton S Hershey Medical Ctr
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Philadelphia, Pennsylvania, Spojené státy, 19107 4215
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Spojené státy, 15224
- West Penn Hospital
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Pittsburgh, Pennsylvania, Spojené státy, 15232
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425-8900
- Medical University of South Carolina
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Greenville, South Carolina, Spojené státy, 29607
- Bon Secours Saint Francis Cancer Center
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Texas
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Dallas, Texas, Spojené státy, 75390
- UT Southwestern Parkland Hospital
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Dallas, Texas, Spojené státy, 75390
- UT Southwestern
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Houston, Texas, Spojené státy, 77030
- Houston Methodist Neal Cancer Center at Texas Medical Center
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Spojené státy, 22903
- University of Virginia
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Washington
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Seattle, Washington, Spojené státy, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Spojené státy, 98104
- Swedish Cancer Institute
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Tacoma, Washington, Spojené státy, 98405
- NorthWest Medical Specialties, PLLC
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Wisconsin
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La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Health System
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College Of Wisconsin
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-
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-
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Ankara, Turecko (Türkiye), 06680
- Liv Hospital Ankara
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Ankara, Turecko (Türkiye), 06620
- Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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Denizli, Turecko (Türkiye), 20070
- Pamukkale Universitesi Tip Fakultesi
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Istanbul, Turecko (Türkiye), 34214
- Medipol University Hospital
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Samsun, Turecko (Türkiye), 55200
- Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
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Brno-Bohunice, Česko, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Česko, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Česko, 779 00
- University Hospital Olomouc
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Ostrava, Česko, 708 52
- Fakultni Nemocnice Ostrava
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-
-
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Beijing, Čína, 100034
- Peking University First Hospital
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Beijing, Čína, 100020
- Beijing Chaoyang Hospital
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Beijing, Čína, 101199
- Peking University People's Hospital
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Changsha, Čína, 410011
- The Second Xiangya Hospital of Central South Hospital
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Changzhou, Čína, 213000
- Changzhou No 2 Peoples Hospital
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Chengdu, Čína, 610032
- Sichuan Provincial Peoples Hospital
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Fuzhou, Čína, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Fuzhou, Čína, 350001
- Fujian Meidical University Union Hospital
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Guangzhou, Čína, 510515
- Nanfang Hospital of Southern Medical Hospital
-
Guangzhou, Čína, 510060
- Sun Yat Sen University Cancer Center
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Hangzhou, Čína, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, Čína, 310003
- First hospital affiliated of Zhejiang Medical university
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Hohhot, Čína, 010051
- The Affiliated Hospital of Inner Mongolia Medical College
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Jinan, Čína, 250012
- Qilu Hospital of Shandong University
-
Nanchang, Čína, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, Čína, 210008
- Nanjing Drum Tower Hospital
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Nanning, Čína, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Čína, 200025
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
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Shanghai, Čína, 200065
- Tongji Hospital of Tongji University
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Shanghai, Čína, 200434
- Shanghai Fourth People s Hospital
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Shenyang, Čína, 110055
- Shengjing Hospital Of China Medical University
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Shenzhen, Čína, 518036
- Peking University Shenzhen Hospital
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Taiyuan, Čína, 030032
- Shanxi Bethune Hospital
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Tianjin, Čína, 30060
- Tianjin Medical University Cancer Institute and Hospital
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Wenzhou, Čína, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Čína, 430030
- Tongji Hospital, Tongji Medical College of HUST
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Xi'an, Čína, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xiamen, Čína, 361026
- The first affiliated hospital of xiamen university
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Athens, Řecko, 115 28
- Alexandra General Hospital of Athens
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Athens, Řecko, 115 25
- 251 Airforces Hospital
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Thessaloniki, Řecko, 546 39
- Theageneio Cancer Hospital
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-
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Asturias, Španělsko, 33394
- Hosp. de Cabuenes
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Barcelona, Španělsko, 08035
- Hosp Univ Vall D Hebron
-
Burgos, Španělsko, 09003
- Hosp. Univ. de Burgos
-
Cáceres, Španělsko, 10003
- Hosp. San Pedro de Alcantara
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Donostia / San Sebastian, Španělsko, 20014
- Hosp. Univ. Donostia
-
Granada, Španělsko, 18014
- Hosp. Univ. Virgen de Las Nieves
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Lugo, Španělsko, 27003
- Hosp. Univ. Lucus Augusti
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Madrid, Španělsko, 28046
- Hosp. Univ. La Paz
-
Palma de Mallorca, Španělsko, 07120
- Hosp. Univ. Son Espases
-
Pamplona, Španělsko, 31008
- Clinica Univ. de Navarra
-
Pamplona, Španělsko, 31008
- Complejo Hosp de Navarra - Hosp de Navarra
-
Salamanca, Španělsko, 37007
- Hosp Clinico Univ de Salamanca
-
Santander, Španělsko, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Španělsko, 15706
- Hosp. Clinico Univ. de Santiago
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-
-
-
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Lund, Švédsko, 221 85
- Skanes universitetssjukhus
-
Umeå, Švédsko, 901 85
- Norrlands Universitetssjukhus
-
Uppsala, Švédsko, 75185
- Akademiska Sjukhuset
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Varberg, Švédsko, 432 81
- Varberg Hospital
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: 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.
Ostatní jména:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
Dexamethasone will be administered either orally or intravenously. Elotuzumab will be administered intravenously.
Ostatní jména:
Bortezomib will be administered as a SC injection.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Progression Free Survival (PFS)
Časové okno: 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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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Overall Response Rate (ORR)
Časové okno: 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
Časové okno: Up to 3 years 5 months
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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
Časové okno: Up to 3 years 5 months
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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
Časové okno: 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)
Časové okno: Up to 3 years 5 months
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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)
Časové okno: Up to 3 years 5 months
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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)
Časové okno: 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
Časové okno: Up to 3 years 5 months
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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
Časové okno: 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)
Časové okno: Up to 3 years 5 months
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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
Časové okno: Up to 3 years 5 months
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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)
Časové okno: Up to 3 years 5 months
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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)
Časové okno: Up to 3 years 5 months
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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
Časové okno: Up to 3 years 5 months
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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
Časové okno: Up to 3 years 5 months
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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
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
Časové okno: Up to 3 years 5 months
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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
Časové okno: Up to 3 years 5 months
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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
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
Časové okno: Up to 3 years 5 months
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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
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Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
Časové okno: Up to 3 years 5 months
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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
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Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
Časové okno: Up to 3 years 5 months
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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
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Number of Participants with Adverse Events (AEs) by Severity
Časové okno: Up to 3 years 5 months
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Novotvary
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Novotvary, plazmatické buňky
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Hemická a lymfatická onemocnění
- Mnohočetný myelom
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Polycyklické sloučeniny
- Anorganické chemikálie
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Steroidy, fluorované
- Těhotenství
- Kyseliny boronové
- Kyseliny, nekarboxylové
- Kyseliny
- Boronové sloučeniny
- Pyraziny
- Bortezomib
- Dexamethason
- Pomalidomid
- elotuzumab
- Talquetamab
Další identifikační čísla studie
Další identifikační čísla studie
- 64407564MMY3009
- 64407564MMY3009 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2022-502446-27-00 (Identifikátor registru: EUCT number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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