A Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

July 31, 2014

Study Completion Date

September 30, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).

DRUG

Best Supportive Care

"Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."

Trial Locations (68)

Unknown

Nedlands

Perth

Linz

Salzburg

Vienna

Arlon

Bruges

Brussels

Roeselare

Brno

Hradec Kralov

Olomouc

Prague

Lyon

Nantes

Nîmes

Dresden

Giessen

Koblenz

Mainz

München

Ulm

Athens

Rio Patras

Budapest

Debrecen

Győr

Gyula

Kaposvár

Pécs

Szeged

Haifa

Jerusalem

Kfar Saba

Nahariva

Petah Tikva

Sheba

Ancona

Novara

Roma

Torino

North Shore

Gdansk

Lodz

Piła

Torum

Warsaw

Wroclaw

Zamość

Moscow

Saint Petersburg

Belgrade

Niš

Bratislava

Incheon

Seoul

Barcelona

Guipuzcoa

Murcia

Salamanca

Seville

Valencia

Zaragoza

Uppsala

Hampshire

London

Manchester

Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY