80
Participants
Start Date
April 30, 2013
Primary Completion Date
February 29, 2016
Study Completion Date
February 29, 2016
bortezomib (optimized retreatment)
Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1, 4, 8 and 11, every 21 days of cycle 1 and 2; injection on Days 1, 8, 15, 22, every 35 days for cycles 3 to 6; followed by injections on Days 1, 8, 15, 22 every 35 days (Group A1) or injections every other week (Group A2). Treatment will be stopped at confirmed disease progression
dexamethasone (optimized retreatment)
Type= exact number, unit = mg, number = 20, form = tablet, route = oral, intake on Days 1, 2, 4, 5, 8, 9, 11 and 12, every 21 days of cycle 1 and 2; intake on Days 1, 2, 8, 9, 15, 16, 22 and 23 every 35 days for cycles 3 to 6
bortezomib (standard retreatment)
Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1,4,8,11, every 21 days for cycles 1 to 8 or until confirmed disease progression
dexamethasone (standard retreatment)
Type = exact number, unit = mg, number = 20, form = tablet, route= oral, intake on Days 1, 2, 4, 5, 8, 9, 11, 12, every 21 days for cycles 1 to 8 or until confirmed disease progression
Antwerp
Edegem
Haine-Saint-Paul
Hasselt
Sint-Niklaas
Turnhout
Yvoir
Helsinki
Lahti
Turku
Lille
Paris
Périgueux
Rennes
Tours
Cologne
Dresden
Heidelberg
Mutlangen
Osnabrück
Rostock
Haifa
Nahariya
Ramat Gan
Apeldoorn
Deventer
Heerlen
Tilburg
Zwolle
Fredrikstad
Stavanger
Trondheim
Brzozów
Chorzów
Lodz
Lublin
Olsztyn
Opole
Słupsk
Wroclaw
Coimbra
Ponta Delgada
Porto
Borås
Falun
Huddinge
Stockholm
Adana
Ankara
Bursa
Istanbul
Izmir
Samsun
Trabzon
Lead Sponsor
Janssen-Cilag International NV
INDUSTRY