Conditions: Myelodysplastic Syndrome MDS
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS).

Lenalidomide is a drug that alters 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 reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. As it is being used in this study it is considered an investigational use. An "investigational use" is a use that is being tested and is not approved by the FDA.

Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS.

"Study drug" refers to the combination of lenalidomide and prednisone.

Detailed description:
10 mg/day of lenalidomide will be taken by mouth on days 1 - 28 of cycles 1-6. Dosing will be in the morning at approximately the same time each day.

Planned prednisone dose:

* 30 mg by mouth daily, days 1-28 of cycle 1
* 20 mg by mouth daily, days 1-28 of cycle 2
* 10 mg by mouth daily, days 1-28 of cycle 3
* 10 mg by mouth every other day on days 1-28 of cycles 4-6
* 5 mg by mouth every other day for responders beyond cycle 6

Arms:
arm 1: All participants received lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).

Interventions: intervention 1: Prednisone intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Prednisone therapy for 6 cycles (24 weeks). intervention 2: Lenalidomide therapy for 6 cycles (24 weeks).

Protocol document: