Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

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

DRUG

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

DRUG

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

DRUG

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

Trial Locations (54)

Unknown

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

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT01910987 - Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib | Biotech Hunter | Biotech Hunter