Azra Raza, M.D. and Naomi Galili, Ph,D, from the MDS Program at SVCCC have received a 2 year, $275,000 grant from the National Institutes of Health. The grant will support the laboratory component of the clinical trial titled: A Prospective Trial of Revlimid® in Transfusion Dependent Patients with non-del(5q) Low/Intermediate-1 Risk Myelodysplastic Syndrome.
The drug Revlimid (lenalidomide) is currently approved only for lower risk myelodysplastic syndrome (MDS) patients with a specific chromosome abnormality involving deletion of the long arm of chromosome 5. Clinical trials reported by Dr. Raza and colleagues have shown that while approximately 70% of patients with del(5q) cytogenetic abnormality respond to Revlimid by becoming completely transfusion independent, only 43% of patients without del(5q) respond.
Drs. Raza and Galili had done earlier work in MDS patients without del(5q) cytogenetic abnormality suggesting that patients who benefitted from lenalidomide had a different genetic signature in their bone marrow cells than those patients who did not benefit. Drs. Raza and Galili designed this study to compare the gene expression profiles of responders versus non-responders. The hope is that pre-screening patients for the expression signature will eventually allow clinicians to restrict use of this drug to only the patients likely to benefit.
Purpose
Cells in the bone marrow make proteins through messages that are carried from the genes. The amount of the message tells us if the protein it is going to make is high or low. This is known as expression of genes. The purpose of this study is to conduct a prospective trial testing the idea that expression of specific genes can help to predict which patients will respond to study drug administration with Revlimid (lenalidomide).
Eligibility
Several criteria must be met to be eligible for this study, including but not limited to the following:
- Diagnosis of low/Intermediate-1 risk MDS with a non-del(5q) karyotype
- Transfusion dependence
- Eligible for treatment with Revlimid
- Adequate cardiac, liver and kidney function
- Age 21 and older
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