Clinical trial NCT01222195
Conditions: Leukemia
Keywords: Myelodysplastic Syndrome Red cell transfusion independence Darbepoetin alfa Lenalidomide CC-5013 Revlimid Aranesp Erythropoietin Erythropoiesis Stimulating Protein
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-02-01; Completion date: 2010-07-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be studied.

Detailed description:
Lenalidomide is designed to change the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Darbepoetin alfa is designed to stimulate production of red blood cells.

If you are found to be eligible to take part in this study, you will take lenalidomide once a day by mouth on Days 1-21. On Days 22-28, you will not take lenalidomide. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).

Due to the uncertain amount of re-absorption of lenalidomide, there will be no re-dose for lenalidomide if you vomit the pills.

Every 28 days is called a study "cycle". Since lenalidomide may cause blood clots, you will take aspirin every day, by mouth, unless your platelet count is too low. Darbepoetin alfa will be given through a needle under the skin (subcutaneously) once every 2 weeks.

You will be given a drug diary. In this diary, you will record when you take the study drugs and any side effects you may have.

During Cycle 1, you will have a study visit just before receiving lenalidomide and then once a month for the first 3 months, then every 3 months after that. At these visits, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Your drug diary will be checked and you will return the bottle of the study drug and any unused drug. You will receive one cycle supply of lenalidomide.

At the end of the first 3 cycles, or earlier if your doctor thinks it is necessary, you will have a bone marrow aspirate. If your doctor thinks it is necessary, you may have additional bone marrow aspirates while on study.

You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.

Once you are off-study, you will have an end-of-study visit. At this visit, blood (about 2 tablespoons) will be drawn for routine tests. If you are a woman who is able to have children, a portion of this blood will be used for a blood pregnancy test.

You will be contacted by phone 30 days after you are taken off study, and then every 3 months. You will be asked about any side effects you are experiencing, any new treatments you are having, and if you have needed any blood products. The phone call should take about 10 minutes.

This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study is investigational. Darbepoetin alfa is approved by FDA for treatment of low red blood cell in patients with cancer and kidney disease. The use of these drugs together is considered to be investigational. Up to 39 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Interventions: intervention 1: Lenalidomide intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: 10 mg/day by mouth on days 1-21 of every 28 day cycle. intervention 2: 200 mcg subcutaneously every 2 weeks of a 28 cycle.

Protocol documents: