NCT00608907 - An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

April 30, 2010

Conditions

Multiple MyelomaNon-Hodgkin's Lymphoma

Interventions

DRUG

bortezomib

1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle

DRUG

bortezomib, rifampicin

bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3

DRUG

bortezomib, dexamethasone

bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3

Trial Locations (9)

Department of Hematology - University of the Free State, Bloemfontein

Divisione di Ematologia - Ospedale S Eugenio - P. le dell'Umanesimo, Rome

Hematology Institute - Davidoff Center - Rabin Medical Center, Petah Tikva

Medical Academy - Dept of Hematology and Transplantology, Gdansk

Klinika Nowotworow Ukladu - Chlonnego - Centrum Onkologii - Instytut, Warsaw

Hematological Oncology, Parow

Department of Medical Oncology - Ward 51 - Pretoria Academic Hospital, Pretoria

Plymouth Hospitals NHS Trust - Derriford Hospital, Derriford

Hematology Department Combined Laboratories - Derriford Hospital, Plymouth