Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of
placebo in subjects with red blood cell (RBC) transfusion-dependent low- or
intermediate-1-risk IPSS MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.
Study participants were randomized to one of the two treatment groups or to placebo and took
the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid
response. If participants did not achieve at least a minor erythroid response, they were
discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid
responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For
participants that were still responding at the end of Double-Blind phase, they could then
rollover into the Open-Label phase for an additional two years. Participants could remain on
study for up to a total of 3 years. All participants who discontinued from the study were
followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).