An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

February 28, 2009

Study Completion Date

January 31, 2010

Conditions
Multiple Myeloma
Interventions
DRUG

Bortezomib

Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m\^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m\^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).

Trial Locations (38)

Unknown

Graz

Oberpullendorf

Vienna

Antwerp

Brussels

Ghent

Roeselare

Dijon

Limousis

Marseille

Nantes

Paris

Pessac

Bad Soden

Berlin

Cologne

Erlangen

Hamburg

Hamm

Hanover

Kiel

Mainz

Würselen

Athens

Pátrai

Thessalonikis

Luxembourg

Almada

Coimbra

Lisbon

Barcelona

Cadiz

Málaga

Salamanca

Santiago de Compostela

Seville

Toledo

Zaragoza

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY