Clinical Trial: Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)

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 Summary:

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 wil
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Number of Patients With a Transfusion Independence Response [ Time Frame: Over six 28-day cycles (approximately 168 days) ]

Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.


Original Primary Outcome: Response Rate [ Time Frame: Over six 28-day cycles ]

Response rate defined as the rate of transfusion independence for at least 8 weeks, anytime during the six 28-day cycles of therapy.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: October 14, 2010
Date Started: February 2008
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012