Lenalidomide and Prednisone in Low and Int-1 Myelodysplastic Syndrome (MDS) Non 5q MDS
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients|
- Number of Participants With Erythroid Response [ Time Frame: Up to 7 months ] [ Designated as safety issue: No ]The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.
- Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment [ Time Frame: Up to 54 months ] [ Designated as safety issue: Yes ]Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||August 2016|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide and Prednisone Therapy
All participants received lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Prednisone therapy for 6 cycles (24 weeks).
Other Name: DeltasoneDrug: Lenalidomide
Lenalidomide therapy for 6 cycles (24 weeks).
Other Name: REVLIMID®
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133275
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Rami Komrokji, M.D.||H. Lee Moffitt Cancer Center and Research Institute|