A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

November 28, 2006

Primary Completion Date

August 16, 2011

Study Completion Date

September 24, 2019

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (80)

Unknown

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

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT00401843 - A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter