Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00271804
Eligibility Criteria:
Inclusion Criteria:
* Myelodysplastic syndrome with a IPSS score of 0.5 or greater
* May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
* ECOG performance status of 0-2
* Life expectancy greater than 3 months
* Total bilirubin \</+ 2xULN
* ALT and AST \</+ 3xULN
* Calculated creatinine clearance \> 30 ml/min
* Use of appropriate method of contraception during the study
* ANC \> 0.5 x 10(9)
* Platelet count \> 30 x 10(9)
* Consideration of treatment with 5 azacytidine is encouraged by not required
Exclusion Criteria:
* Ejection fraction \< 40%
* myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Women who are pregnant or breast-feeding
* Major surgery within 4 weeks prior to enrollment
* \>/= grade 2 peripheral neuropathy within 14 days prior to enrollment
* Uncontrolled intercurrent illness
* Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
* Hypersensitivity to bortezomib, boron, or mannitol
* Received an investigational drug within 14 days of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00271804
Study Brief:
Protocol Section:
NCT00271804