Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS
Status:
Completed
Trial end date:
2019-11-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute