A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

401

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Multiple Myeloma
Interventions
DRUG

Cyclophosphamide

In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles.

DRUG

Bortezomib

Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

DRUG

Dexamethasone

Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Trial Locations (34)

Unknown

Berg

Berlin

Bremen

Dresden

Erlangen

Frankfurt am Main

Freiburg im Breisgau

Göttingen

Greifswald

Halle

Hamburg

Hamm

Hanover

Homburg

Jena

Karlsruhe

Kiel

Lübeck

Magdeburg

Mainz

Mutlangen

München

Münster

Nuremberg

Oldenburg

Potsdam

Regensburg

Rehling

Rostock

Stuttgart

Tübingen

Ulm

Villingen-Schwenningen

Würzburg

All Listed Sponsors
lead

Janssen-Cilag G.m.b.H

INDUSTRY

NCT00833560 - A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy | Biotech Hunter | Biotech Hunter