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Lenalidomide +/− Epoetin Alfa for Myelodysplastic Syndrome
Study Summary
This trial studies lenalidomide with or without epoetin alfa to treat patients with myelodysplastic syndrome and anemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't received any non-transfusion treatments for MDS in the last 28 days.I am 18 years old or older.I have been diagnosed with MDS or CMML for at least 3 months.I have been diagnosed with MDS or CMML with low white blood cell count for 3 months or more.To participate in the study, you need to have a bone marrow biopsy and cytogenetics test done. These tests are needed to determine your eligibility for the study based on your International Prognostic Scoring System category. You don't need to wait for the test results before starting the next cycle unless your doctor thinks it's necessary. If there are signs of disease progression, your doctor may wait for the test results before starting the next cycle. If you start a cycle and the test results show that you should not continue on the treatment, please let the study team know.I completed 16 weeks of lenalidomide without enough improvement or relapsed after some improvement.I have anemia with hemoglobin below 9.5 g/dL or I need blood transfusions regularly.My bone marrow disease is considered low or intermediate-1 risk based on a special test.I have been treated with lenalidomide before.My white blood cell count is 12,000/mcL or higher due to CMML.My MDS developed after treatment for cancer or an autoimmune disease.I don't have severe side effects from lenalidomide that would stop me from continuing treatment.You have had severe allergic reactions to thalidomide in the past.I have tried erythropoietin treatment for anemia without success.I have been cancer-free for over 3 years, except for certain skin cancers or early-stage cervical or breast cancer.You had a severe skin rash caused by thalidomide in the past.I haven't received any treatment for MDS except possibly hydrocortisone in the last 28 days.If you don't require blood transfusions, we need to see at least 2 measurements of your hemoglobin levels before the trial.My platelet count is at least 50,000 without recent transfusions.I am using effective birth control while on lenalidomide therapy.I have not responded well to treatments aimed at increasing my red blood cells.I get less than 2 blood transfusions in 4 weeks and will use my average hemoglobin levels from the last 8 weeks.I have anemia with hemoglobin under 9.5 g/dL or need regular blood transfusions.I have had a blood clot in the last 3 years.I have anemia due to a deficiency or bleeding.I have seizures or high blood pressure that is not well-controlled.I haven't used any strong chemotherapy or experimental drugs for MDS in the last 8 weeks.My blood disorder is considered low or intermediate-1 risk.I have been receiving blood transfusions regularly and have not used specific anemia treatments.
- Group 1: Arm A (lenalidomide)
- Group 2: Arm B (lenalidomide, epoetin alfa)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you walk me through other studies that have been conducted using Lenalidomide?
"To date, lenalidomide has been included in 1,104 completed clinical trials since its inception at University of Wisconsin Carbone Cancer Center in 2004. As of now, there are 292 active trials underway, with a significant portion of these taking place in Jefferson City, Missouri."
What medical condition is Lenalidomide typically used to treat?
"Lenalidomide has been found to be an effective at treating chronic lymphocytic leukemia, in patients that have had at two prior systemic chemotherapy regimens, and those that have undergone noncardiac surgery."
What are the side effects of Lenalidomide?
"Lenalidomide has undergone multiple clinical trials with promising data, meaning it has been deemed safe by our team and given a score of 3."
Are people with the qualifying medical condition currently being accepted into the study?
"Unfortunately, this particular study is no longer recruiting patients. The trial was first posted on 1/29/2009 and was last updated on 10/11/2022. If you are exploring for other studies, there are presently 1871 clinical trials actively admitting patients with anemia and 292 studies for Lenalidomide actively looking for participants."
Is this study being conducted at multiple locations throughout the city?
"There are 100 sites where this trial is being offered, some of which are Capital Region Southwest Campus in Jefferson City, Marin Cancer Care Inc in Greenbrae, and Menorah Medical Center in Overland Park."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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