A Phase II Clinical Trial of Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-del (5q) MDS Patients
After the screening test results come back, then participants and the study doctor and study
staff will decide whether or not the patient should be in the study. Once it has been
determined, patients may enter the study and if they agree, then patients will begin the
study drug.
When enrolled into this study, patients will be given study drug for 6 cycles (24 weeks).
Each cycle is 28 days (4 weeks).
Patients will be given a prescription for 10 mg/day of lenalidomide to take orally (by
mouth) on days 1 - 28 of cycles 1-6. Dosing will be in the morning at approximately the same
time each day. Prescriptions must be filled within 7 days.
If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day.
If it is missed for the entire day, it should not be made up.
The prednisone dose will be as follows:
- 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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Erythroid Response
The primary endpoint of this study is to estimate the rate of erythroid response using International Working Group (IWG) 2006 criteria to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk MDS with symptomatic anemia.
Average of 7 Months
No
Rami Komrokji, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC-16099
NCT01133275
April 2010
June 2014
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |