Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)
Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with
standard-of-care steroid treatment you are already receiving, can help to control Chronic
Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the
steroids will also be studied.
Primary Objectives:
- To assess the response rate of chronic GVHD to Lenalidomide after failing steroids
- To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD
Secondary Objectives:
- To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able
to discontinue steroids while receiving or following therapy with Lenalidomide)
- To assess changes in QOL after treatment with Lenalidomide
- To analyze survival at 6 and 12 months after initiation of Lenalidomide
- To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12
months after initiation of Lenalidomide