A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

Who is this study for? Patients with Multiple Myeloma
Status: Recruiting
Location: See all (164) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Capable of giving signed informed consent.

• Male or female, 18 years or older.

• Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy.

• Must have at least 1 aspect of measurable disease defined as one of the following;

• Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or

• Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or

• Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.

• Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present

• All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.

• Adequate organ system functions as mentioned in the protocol.

• Male and female participants agree to abide by protocol-defined contraceptive requirements.

Locations
United States
Arizona
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Tucson
Colorado
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Denver
Florida
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Fort Myers
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New Port Richey
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Pembroke Pines
Idaho
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Coeur D'alene
Massachusetts
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Boston
Missouri
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Kansas City
Pennsylvania
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Pittsburgh
Tennessee
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Nashville
Washington
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Seattle
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Spokane
Wisconsin
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Milwaukee
Other Locations
Australia
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Adelaide
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Benowa
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Canberra
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Darlinghurst
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Fitzroy
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Geelong
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Gosford
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Heidelberg
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Malvern
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Nedlands
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Port Macquarie
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Randwick
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South Brisbane
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Wollongong
Brazil
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Curitiba
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Joinville
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Porto Alegre
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Porto Alegre
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Rio De Janeiro
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São Paulo
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São Paulo
Canada
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Montreal
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Ottawa
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Toronto
China
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Changsha
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Guangzhou
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Nanchang
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Shenyang
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Shenzhen
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Tianjin
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Wuhan
France
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Dijon Cedex
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Marseille Cedex 9
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Périgueux Cedex
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Toulouse Cedex 9
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Vandeouvre-les-nancy
Germany
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Berlin
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Hamburg
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Heidelberg
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Jena
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Leipzig
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Mainz
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Tuebingen
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Wuerzburg
Greece
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Athens
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Athens
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Athens
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Athens
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Ioannina
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Larisa
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Rio/patras
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Thessaloniki
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Thessaloniki
Israel
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Ashdod
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Beer-sheva
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Haifa
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Jerusalem
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Jerusalem
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Kfar Saba
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Nahariya
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Petach Tikva
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Ramat Gan
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Tel Aviv
Italy
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Bologna
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Milano
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Pavia
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Roma
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San Giovanni Rotondo
Japan
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Aichi
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Chiba
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Ehime
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Fukuoka
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Fukushima
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Gunma
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Gunma
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Hiroshima
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Hokkaido
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Iwate
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Kumamoto
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Kyoto
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Okayama
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Osaka
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Saitama
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Tokushima
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Tokyo
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Tokyo
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Tottori
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Yamagata
New Zealand
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Auckland
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Auckland
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Christchurch
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Dunedin
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Grafton, Auckland
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Hamilton
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Tauranga
Poland
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Bydgoszcz
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Gdansk
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Krakow
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Lodz
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Lublin
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Wroclaw
Republic of Korea
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Busan
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Gyeonggi-do
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Hwasun-gun, Jeollanam-do
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Incheon
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Seoul
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Seoul
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Seoul
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Seoul
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Ulsan
Russian Federation
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Kaluga
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Moscow
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Nizhniy Novgorod
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Novosibirsk
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Omsk
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Saint Petersburg
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Samara
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Sochi
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St. Petersburg
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St'petersburg
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Tula
Spain
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Badalona
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Barcelona
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Gijon
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Hospitalet De Llobregat (barcelona)
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Madrid
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Madrid
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Móstoles
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Murcia
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Palma De Mallorca
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Pamplona
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Pozuelo De Alarcón/madrid
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Salamanca
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Sevilla
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Valencia
Turkey
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Ankara
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Ankara
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Ankara
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Istanbul
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Izmir
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Izmir
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Kocaeli
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Mersin
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Samsun
United Kingdom
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Airdrie
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Bournemouth
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London
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Plymouth
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Southampton
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Stoke-on-trent
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Sutton
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: October 1, 2020
Estimated Completion Date: March 31, 2028
Participants
Target number of participants: 300
Treatments
Experimental: Arm A: Belantamab mafodotin plus Pomalidomide and Dexamethasone
Experimental: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
Authors
Clifton Mo, Isaac Levy, Sharon Jackson, Kevin Boyd, Binod Dhakal, Syed Farhan Zafar, Brett Gourley, Santhosh Sadashiv, Danko Martincic, Jesus G Berdeja, Henning Schade, Suman Kambhampati, Fei Li, Xin Li, Aharon Ronson, Edwin Lee, Song-Yau Wang, Denis Caillot, Pierre Feugier, Markus Munder, Claire Calmettes, Marie von Lilienfeld-Toal, Hannah Mary Hunter, Iain Singer, Katja Weisel, Britta Besemer, Rachel Hall, Maike de Wit, Aurore Perrot, Konstantinos Anargyrou, Hugh Goodman, Mehmet Turgut, Hayri Ozsan, Andrew Lim, Jock Simpson, Jakub Radocha, Inna Tsoran-Rosenthal, Magdalena Dutka, HyeonSeok Eom, Emilie Lemieux-Blanchard, Manuel R Modiano, Melita Kenealy, Vladimir Ivanovich Vorobiev, Merit Hanna, Anil Tombak, Celia Suriu, Athanasios Galanopoulos, María del Carmen Martínez Chamorro, Yuriy Osipov, Olga S. Uspenskaya, Dmitriy Kirtbaya, Kathryn Forwood, Yulia Dyachkova, Taiga Kuroi, Sergey Semochkin, Lauriane Clement-Filliatre, Cecily Forsyth, Zafer Gulbas, Marcelo Pitombeira de Lacerda, Marc Raab, Nicole Yu-Shan Chien, Evdoxia Hatjiharissi, Kenichi Ishizawa, Hanlon Sia, Aristeidis Chaidos, Vania Hungria, Kihyun Kim, Ory Rouvio, Weiwei Sui, Hila Magen, Kosei Matsue, Mikhail Dvorkin, Zhongjun Xia, Meral Beksac, Peter Ganly, Zubeyde Ozkurt, Takayuki Ikezoe, Irit Avivi, Michiko Ichii, Jae-Cheol Jo, Igor Davydkin, Arleigh McCurdy, Peter Presgrave, Sosana Delimpasi, Hiroshi Handa, Olga Samoilova, Tomasz Wrobel, Huey-Shin Cindy Lee, Gustaro A Fonseca, Javier de la Rubia Comos, Jae Hoon Lee, Luca Baldini, Jayr Schmidt Filho, Bradley Augustson, Tadeusz Robak, Hang Quach, Jin Seok Kim, Eleftheria Hatzimichael, Philip Campbell, Jaroslaw Czyz, Shinsuke Iida, Ludek Pour, Ian Irving, Morio Matsumoto, Youngil Koh, Maurizio Martelli, Meletios Dimopoulos, Argiris S. Symeonidis, Edward Libby, Omur G Sevindik, Merav Leiba, Xin Du, Moshe Etzion Gatt, Artur Jurczyszyn, Laura Maria Fogliatto, Laura Rosinol Dachs, Estrella Carrillo Cruz, Angelo Maiolino, Krzysztof Giannopoulos, Guray Saydam, Suzanne Trudel, Silvia Mangiacavalli, Gillian Corbett, Osnat Jarchowsky Dolberg, Ivan Spicka, Felipe De Arriba de la Fuente, Martin Kortuem, Keith Fay, Kamaraj Karunanithi, Marcelo Capra, Mark Hertzberg, Jesús San Miguel Izquierdo, Je-Jung Lee, Esther González García, George Vassilopoulos, Henry Chan, Matthew Jenner, Michail Iskas, Sergey Voloshin, Anne-Marie Stoppa, Alberto Velasco Valdazo, Mercedes Gironella Mesa, Chang Ki Min, Amos M Cohen, Tomoaki Fujisaki, Adrián Alegre Amor, Antonia Sampol Mayol, Elena Volodicheva, Ho-Jin Shin, Yasuhito Terui, Elena Borisenkova, María Victoria Mateos Manteca, Nicola Cascavilla, Kazutaka Sunami, Michele Cavo, Mehmet Sinan Dal, Toshiro Kawakita, Wei Yang, Tetsuya Fukuda, Francisco Cordeiro, Yoichi Imai, Junya Kuroda, JaMin Byun, Shuji Ozaki, Chunyan Sun, Ana Maria Sureda Balarí, Hiromi Iwasaki, Kazuhito Suzuki, Shigeki Ito, Hideki Goto
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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