This major study enrolled 148 patients who had RBC transfusion dependent anemia. RBC transfusion dependence was defined as having received ≥ 2 units of RBCs within 8 weeks prior to study treatment. The study enrolled patients with absolute neutrophil counts (ANC) ≥ 500/mm3, platelet counts ≥ 50,000/mm3, serum creatinine ≤ 2.5 mg/dL, serum SGOT/AST or SGPT/ALT ≤ 3.0 x upper limit of normal (ULN), and serum direct bilirubin ≤ 2.0 mg/dL. Granulocyte colony-stimulating factor was permitted for patients who developed neutropenia or fever in association with neutropenia. Baseline patient and disease-related characteristics are summarized in Table 11.

Table 11: Baseline Demographic and Disease-Related Characteristics in the MDS Study [a] IPSS Risk Category: Low (combined score = 0), Intermediate-1 (combined score = 0.5 to 1.0), Intermediate-2 (combined score = 1.5 to 2.0), High (combined score ≥ 2.5); Combined score = (Marrow blast score + Karyotype score + Cytopenia score)
[b] French-American-British (FAB) classification of MDS. 
 Overall
(N=148)
Age (years)
Median 71.0
Min, Max 37.0, 95.0
Gender  n (%)
Male 51 (34.5)
Female 97 (65.5)
Race n (%)
White 143 (96.6)
Other 5 (3.4)
Duration of MDS (years)
Median 2.5
Min, Max 0.1, 20.7
Del 5 (q31-33) Cytogenetic Abnormality  n (%)
Yes 148 (100.0)
Other cytogenetic abnormalities 37 (25.2)
IPSS Score [a] n (%)
Low (0) 55 (37.2)
Intermediate-1 (0.5-1.0) 65 (43.9)
Intermediate-2 (1.5-2.0) 6 (4.1)
High (≥2.5) 2 (1.4)
Missing 20 (13.5)
FAB Classification [b] from central review n (%)
RA 77 (52.0)
RARS 16 (10.8)
RAEB 30 (20.3)
CMML 3 (2.0)
The frequency of RBC transfusion independence was assessed using criteria modified from the International Working Group (IWG) response criteria for MDS. RBC transfusion independence was defined as the absence of any RBC transfusion during any consecutive “rolling” 56 days (8 weeks) during the treatment period.

Transfusion independence was seen in 99/148 (67%) patients (95% CI [59, 74]). The median duration from the date when RBC transfusion independence was first declared (i.e., the last day of the 56-day RBC transfusion-free period) to the date when an additional transfusion was received after the 56-day transfusion-free period among the 99 responders was 44 weeks (range of 0 to >67 weeks).

Ninety percent of patients who achieved a transfusion benefit did so by completion of three months in the study.

RBC transfusion independence rates were unaffected by age or gender.

The dose of REVLIMID was reduced or interrupted at least once due to an adverse event in 118 (79.7%) of the 148 patients; the median time to the first dose reduction or interruption was 21 days (mean, 35.1 days; range, 2-253 days), and the median duration of the first dose interruption was 22 days (mean, 28.5 days; range, 2-265 days). A second dose reduction or interruption due to adverse events was required in 50 (33.8%) of the 148 patients. The median interval between the first and second dose reduction or interruption was 51 days (mean, 59.7 days; range, 15-205 days) and the median duration o