Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)

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

Timeline

Start

2008-04

Primary completion

2011-08

Completion

2011-08

Outcome

Outcome not reported

Stopped (Enrollment): “Terminated due to slow accrual.”

Drugs

Indications