REVLIMID® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Studied in transfusion-dependent anemia in patients with IPSS lower-risk del 5q MDS with or without additional abnormalities1

Open-label, single-arm, multicenter phase II trial (N=148)1,18a

Clinical Trial Design of del 5q Myelodysplastic Syndromes (MDS) – Study Population, Primary and Secondary End Points

  • The study was not designed or powered to prospectively compare the efficacy of the 2 dosing regimens.
  • Sequential dose reductions to 5 mg/day and 5 mg every other day, as well as dose delays, were allowed for toxicity.
  • G-CSF was permitted for patients who developed neutropenia or fever associated with neutropenia.
  • Additional criteria may apply.
  • RBC transfusion independence was defined as the absence of any RBC transfusion during any consecutive “rolling” 56 days (8 weeks) during the treatment period.

Additional inclusion criteria.1,18

  • Patients 18 years or older with an ECOG status of 0, 1, or 2
  • Transfusion-dependent anemia (≥2 units RBC/8 weeks prior to study treatment)
  • ANC ≥500/mm3
  • Platelets ≥50,000/mm3
  • Serum creatinine ≤2.5 mg/dL
  • Serum SGOT/AST or SGPT/ALT ≤3 x ULN
  • Serum direct bilirubin ≤2.0 mg/dL

The MDS clinical trial enrolled 148 patients who had RBC transfusion-dependent anemia.1

See Baseline Characteristics