Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
The goal of the present study is to assess, through a randomized phase II trial, the efficacy
and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,
ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5
abnormality.
Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4
months. Responders will be eligible for maintenance treatment with cycles identical to the
first cycles, until relapse occurs or until unacceptable toxicity.