Lenalidomide +/− Epoetin Alfa for Myelodysplastic Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants stop all non-transfusion therapy for myelodysplastic syndrome (MDS) for 28 days before starting the study treatment. This includes all types of growth factors.
What data supports the effectiveness of the drug Lenalidomide combined with Epoetin Alfa for treating myelodysplastic syndrome?
Research shows that Lenalidomide can improve hemoglobin levels and reduce the need for blood transfusions in patients with certain types of myelodysplastic syndrome (MDS), especially those with a specific chromosome abnormality (5q deletion). Combining it with Epoetin Alfa, which helps stimulate red blood cell production, may enhance these benefits for patients with anemia due to MDS.12345
Is the combination of Lenalidomide and Epoetin Alfa safe for treating myelodysplastic syndrome?
Lenalidomide is generally considered safe for treating certain types of myelodysplastic syndrome, but it can cause side effects like low blood cell counts, which are usually managed by adjusting the dose. There is a risk of blood clots when used with erythropoiesis-stimulating agents like Epoetin Alfa, so monitoring is important.56789
What makes the drug Lenalidomide unique for treating myelodysplastic syndrome?
Lenalidomide is unique because it is an oral drug that not only helps improve anemia in patients with myelodysplastic syndrome, especially those with a specific chromosome abnormality (5q deletion), but also has anti-cancer and anti-inflammatory properties. It can be used alone or with epoetin alfa to enhance the body's response to anemia treatment.145910
What is the purpose of this trial?
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. 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.
Research Team
Amit K Verma
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
Adults diagnosed with low- or intermediate-1-risk myelodysplastic syndrome (MDS) and anemia, who have not responded to erythropoietin treatment or are unlikely to respond. Participants must have adequate organ function, no severe allergies to thalidomide, no recent malignancies other than MDS, and not be pregnant. They should also not have had any MDS treatments in the last 28 days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenalidomide with or without epoetin alfa for 4 cycles of 28 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants who achieve a major erythroid response may continue treatment beyond 4 cycles
Treatment Details
Interventions
- Epoetin Alfa
- Lenalidomide
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor