Randomized Phase II Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide Alone and in Combination with Epoetin Alfa in Subjects withLow or Intermediate-1 Risk MDS and Symptomatic Anemia

September 23, 2009
E2905
Anemia, Chronic Myelomonocytic Leukemia
Lucio DiNunno, MD

Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells.

https://clinicaltrials.gov/

  • Patients must not have known human immunodeficiency virus (HIV)-1 seropositivity
  • Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
  • Patients must not have prior therapy with lenalidomide
  • Patients must not have a diagnosis of uncontrolled seizure or uncontrolled hypertension
  • Patients must not have used cytotoxic chemotherapeutic agents or experimental agents
  • Patient must have documented diagnosis of myelodysplastic syndrome (MDS) lasting at least three months or non-proliferative chronic myelomonocytic leukemia
  • Must have symptomatic anemia untransfused with hemoglobin < 9.5 g/dL confirmed for =< 8 weeks before randomization
  • Patients must be off all non-transfusion therapy for MDS for 28 days prior to initiation of study treatment, including all types of growth factors; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
  • Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
Closed
III
Kathy Seymour, BSN
(331) 221-2168