Myelodysplastic Syndrome Clinical Trial
Official title:
A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients
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.
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
;
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