At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Documented MDS diagnosis meeting IPSS criteria for low or intermediate-1 risk with del(5q) cytogenetic abnormality
- ✓RBC transfusion-dependent anemia: ≥1 transfusion per 56-day period within the prior 112 days
- ✕Prior therapy with lenalidomide
- ✕Proliferative CMML (WBC ≥12,000/mL)
- ✕Grade ≥2 allergic reaction to thalidomide (per CTCAE v3.0)
- ✕Prior desquamating (blistering) rash while taking thalidomide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion (Del) 5q[31] Cytogenetic Abnormality
In Brief
A Phase 3 clinical trial evaluating Lenalidomide 5 mg, Lenalidomide 10 mg, and 1 other intervention for Myelodysplastic Syndromes. Completed, enrolled 205 participants across 38 sites in 9 countries.
Detailed 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).
Study Details
Timeline
Interventions
Lenalidomide 5 mg daily 28/28 days
Lenalidomide 10 mg daily 21/28 days
Placebo, matching to active study drug arms