A Phase III Study of Lenalidomide Alone and in Combination with Epoetin Alfa in Patients with Myelodysplastic Syndromes and Symptomatic Anemia

Protocol
10-128
Full Title
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia (ECOG E2905)
Purpose

Myelodysplastic syndromes (MDS) are a group of closely related diseases that arise in the bone marrow. In patients with MDS, the bone marrow makes reduced numbers of red blood cells (resulting in anemia), white blood cells (which fight infection), or platelets (which prevent or stop bleeding), or any combination of the three.

The purpose of this study is to compare the effects of treatment with lenalidomide alone and in combination with epoetin alfa on bone marrow function in patients with MDS and symptomatic anemia. Anemia can cause fatigue, shortness of breath, and other symptoms. The goal of therapy is to raise red blood cell counts and reduce the number of red blood cell transfusions that MDS patients need.

Epoetin alfa boosts the production of red blood cells. Lenalidomide might make epoetin alfa and other red blood cell hormones work better against anemia. Patients will be randomly assigned to receive lenalidomide alone or with epoetin alfa. Both drugs are approved for use in patients, though their use together is considered investigational.

Investigator
Virginia M. Klimek, MD
Virginia M. Klimek - Physician Profile
Co-Investigators

Jurcic, Joseph, MD

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have low- or intermediate-1-risk MDS that has existed for at least three months.
  • Patients must have anemia that is causing symptoms.
  • Patients must have MDS that has not responded to treatment with an erythropoietic growth factor or is determined to be unlikely to respond to such treatment.
  • At least 4 weeks must have passed since completion of any non-transfusion therapy.
  • Patients may not have received prior lenalidomide therapy.
  • Patients must be at least age 18.

For more information about this study and to inquire about eligibility, please contact Dr. Virginia Klimek at 212-639-6519.

Disease(s)
Hematology: Myelodysplastic Syndrome
Leukemia: Myelodysplastic Syndrome
Locations
Related Diseases

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