View Clinical Trial (Medical Research Study)
A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Low Risk Myelodysplastic Syndrome (MDS) Without Del 5Q - NCT01029262-07601(Clinical Trial 685072)
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Hackensack |
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State:
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NJ |
| Zip Code: |
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07601 |
| Conditions: |
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Anemia |
| Purpose: |
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The purpose of this study is to investigate whether lenalidomide would reduce the number of
red blood cell transfusions needed by anemic (RBC transfusion-dependent) subjects with low
or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study will
also investigate the safety of lenalidomide use in these subjects. Two-thirds of the
subjects will receive lenalidomide and one-third of the subjects will receive placebo (does
not contain lenalidomide).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 18 years or older
- Diagnosis of low or intermediate-1 risk MDS with any chromosome karyotype except del
5q[31]
- Anemia that requires red blood cell transfusions
- Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level >
500 mU/mL
- ECOG Performance Status ≤ 2
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of
lenalidomide
- Must agree not to donate blood or semen
- Must be willing to consent to two or more bone marrow aspirate procedures to be
completed during study
Exclusion Criteria:
- Prior treatment with lenalidomide
- Allergic reaction to thalidomide
- Renal insufficiency (CrC1<40 mL/min by Cockroft-Gault method)
- Prior history of cancer, other than MDS, unless the subject has been free of the
disease for ≥ 3 years. (Basal cell carcinoma of the skin, Carcinoma in situ of the
cervix, or stage T1a or T1b prostate cancer is allowed)
- Absolute neutrophil count < 500/uL
- Platelets < 50,000/uL
- AST or ALT > 3X upper limit of normal
- Uncontrolled hyperthyroidism or hypothyroidism
- Significant neuropathy
- Prior stem cell transplantation
- Anemia due to reasons other than MDS
- History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
- Significant active cardiac disease within the past 6 months
- Known HIV infection; known Hepatitis C infection or active Hepatitis B infection |
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| Study is available at: |
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Hackensack University Medical Center
Hackensack, NJ 07601
United States
Primary Contact:
Phone: 201-996-5817
Secondary Contact:
Anne McClain, RN, BSN
Email: amcclain@celgene.com
Phone: 913-266-0336 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
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