A Prospective Trial of Revlimid® in Transfusion Dependent Patients With Non-del (5q) Low/Intermediate-1 Risk Myelodysplastic Syndrome
The first Revlimid® study reported by List et al included all transfusion dependent MDS
patients, but given the early experience which showed a better response in del(5q) patients
and those with lower risk disease, more patients belonging to this category were entered on
the trial. The subsequent multi-center studies were focused entirely on the low/Int-1
patients who were transfusion dependent. In the present study, we would like to recapitulate
the initial study by only treating the transfusion dependent, low and intermediate-1 risk
MDS patients without deletion (5q). Since the predictive assay is most applicable for the
non-del(5q) patients, and to avoid confusion resulting from an admixture of patients with
del(5q) for whom the drug is already FDA approved, we have elected to restrict this clinical
trial to only the non-del(5q) patients.
In the present study, only the non-del(5q) transfusion dependent, low and intermediate-1
risk MDS patients will be treated with single agent Revlimid®. All patients will have their
pre-therapy bone marrows studied by gene expression microarray, Luminex bead assay, and
real-time PCR.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in response signature in transfusion dependent MDS patients
The trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies.
Up to 12 weeks from baseline
Yes
Azra Raza, MD
Principal Investigator
Columbia University
United States: Institutional Review Board
AAAF2696
NCT01178814
April 2009
May 2014
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |