A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
- Each treatment cycle lasts five weeks, during which time participants will come to the
clinic to receive bortezomib intravenously once a week for the first 4 weeks.
Prednisone will be taken orally on a daily basis and dose reduction may be initiated
after 1 cycle of therapy.
- During all treatment cycles, participants will have the following: physical exam and
blood work. At the end of cycle 3 (week 15) the participants cGVHD will be evaluated.
These assessments may include an eye examination, a skin examination, a pulmonary
function test and/or, a flexion assessment test.
- Participants will receive 3 cycles of bortezomib.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall response rate after a 15 week course of bortezomib plus prednisone in patients with cGVHD
John Koreth, MBBS, DPhil
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|