307
Participants
Start Date
November 28, 2006
Primary Completion Date
August 16, 2011
Study Completion Date
September 24, 2019
Siltuximab
Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during cycle 1 in Part 1. Siltuximab 6 mg/kg will be administered as intravenous infusion once every 2 weeks during 42-day Treatment Phase and 35-day Maintenance Phase in Part 2.
Bortezomib
Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus once every 2 weeks during cycle 1 in Part 1. Bortezomib 1.3 mg/m\^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10-day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period during 42-day treatment phase in Part 2. Bortezomib 1.3 mg/m2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) during 35-day Maintenance Phase in Part 2.
Placebo
Matching placebo will be administered as intravenous infusion once every 2 weeks during 42-day treatment phase and 35-day maintenance phase in Part 2.
Dexamethasone
Dexamethasone tablet will be administered in this study at the first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles in treatment phase and maintenance phase of Part 2.
Greenbrae
Los Angeles
Indianapolis
Albuquerque
New York
Syracuse
Chapel Hill
North Charleston
Dallas
Houston
Madison
Antwerp
B-8000 Brugge
Brussels
Edegem
Leuven
Rio de Janeiro
Bulgaria
Pleven
Plovdiv
Vancouver
Québec
Calgary
Brno
Hradec Králové
Prague
Grenoble
Lille Cedex N/a
Montpellier
Pierre-Bénite
Vandœuvre-lès-Nancy
Aschaffenburg
Essen
Mainz
Münster
Stuttgart
Ulm
Athens
Budapest
Debrecen
Gyõr
Nyíregyháza
Szeged
Amersfoort
Amsterdam
Rotterdam
The Hague
Bialystok
Gdansk
Katowice
Lodz
Lublin
Poznan
Wroclaw
Coimbra
Lisbon
Porto
Baia Mare
Brasov
Bucharest
Iași
Tg Mures
Arkhangelsk
Izhevsk
Moscow
Nizhny Novgorod
Novosibirsk
Saint Petersburg
Ufa
Bratislava
Martin
Badalona
Barcelona
Madrid
Salamanca
Valencia
London
Nottingham
Plymouth
Sutton
Janssen Research & Development, LLC
INDUSTRY