E2905 Randomized Ph III Trial Comparing Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (RevlimidÂ®) Alone and in Combination with Epoetin Alfa (ProcritÂ®) in Subjects with Low or Intermediate-1 Risk MDS and Symptomatic Anemia
To compare the rate of major erythroid response (MER) between lenalidomide monotherapy and combined treatment of lenalidomide and epoetin alfa in erythropoietin non-responsive Low/Int-1 risk MDS patients or erythropoietin-treatment naÃ¯ve patients with low probability of erythropoietin benefit.
1. Age: 18 years or older2. Documented diagnosis of MDS lasting at least three months3. International Prognostic Scoring System (IPSS) categories of Low- or Intermediate-1-risk disease4. Symptomatic anemia untransfused with hemoglobin less than 9.5 g/dL less than 8 weeks prior to randomization or with RBC transfusion-dependence confirmed for less than 8 weeks before randomization5. Must have failed treatment with an erythropoietic growth factor, or have a low probability of response to rhu-erythropoietin. 6. Must be off all non-transfusion therapy for MDS for 28 days prior to study treatment. 7. Must have a serum erythropoietin level documented before randomization. 8. Must not have documented iron deficiency. 9. Women must not be pregnant or breastfeeding. 10. Must not have prior therapy with lenalidomide.11. Must not have a diagnosis of uncontrolled seizure or uncontrolled hypertension12. Must not have proliferative (WBC â?¥12,000/mcL) chronic myelomonocytic leukemia (CMML). WBC must be less than 12,000/mcL. 13. Must not have MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases.14. Must not have clinically significant anemia resulting from iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding.15. Must not have used cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 8 weeks of randomization.16. Must not have prior history of malignancy other than MDS (except basal cell or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been confirmed free of disease for greater than 3 years.
Arm A (Lenalidomide Monotherapy)Lenalidomide is taken orally days 1-21 followed by 7 days of no therapy. This regimen will repeat every 28 days for a total of 4 cycles).Arm B (Lenalidomide + Epoetin Alfa)Lenalidomide is taken orally on days 1-21 followed by 7 days of no therapy and epoetin alfa 60,000 units subcutaneously (s.c.) every week. Repeat cycles every 28 days for a total of 4 cyclesPatients who fail to achieve a response on Arm A and patients on Arm A who relapse may be offered to cross over to Arm B to receive combined treatment.
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