Patients with Low-or-Intermediate-1 Risk MDS and Symptomatic Anemia using Revlimid or Revlimid with epoetin alfa (Procrit)
The study is looking for patients with low or intermediate risk of myelodysplastic syndrome and symptomatic anemia . Myelodysplastic syndromes (MDS) are bone marrow stem cell disorders resulting in ineffective blood forming cells. This study is looking at how a drug called Revlimid affects (good or bad) you and your condition when given alone, compared to taking it along with another drug called epoetin alfa. The study wants to find out which treatment is better. Epoetin alfa boosts the production of red blood cells. Revlimid makes young red blood cells more likely to be affected by the growth promoting effects of epoetin alfa and other red blood cell hormones. This study will determine if the combination treatment with epoetin alfa and Revlimid is better than Revlimid alone in improving red blood cell production and in relieving the need for red blood cell transfusions in patients with MDS.
If you are enrolled in this study you will be randomized into 2 groups. Arm A will receive Revlimid by mouth every day for 21 days, while Arm B will receive Revlimid by mouth every day for 21 days and a Procrit injection weekly. This is called a cycle. You will repeat this every 28 days for a total of 4 cycles. At this point you will be evaluated to see if your condition has improved. If you are on Arm A and have not improved, you will be able to switch over to Arm B. If you have improved, you will continue on your medication until your medication is not working anymore. While you are on study you will have blood tests, bone marrow biospies and physical exams to evaluate your condition.
Inclusion Criteria: Diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML)for at least 3 months Determination that your MDS is a low or intermediate-1-risk disease Transfusion (receiving blood) and anemia (not having enough oxygen in your blood) requirements needed to be met to be on study Exclusion Criteria: MDS can not be a result of prior treatment (secondary)
Harry Staszewski, MD
Patricia Ly RN MSN ANP firstname.lastname@example.org