Study of Velcade and Thalidomide in Patients With Myelodysplasia

Stopped early · Phase 1

Conditions studied: Myelodysplastic Syndrome

In brief

The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.

Key facts

Study ID

NCT00271804

Run by

Massachusetts General Hospital

People needed

28

Starts

2005-06-01

Expected to finish

2007-04-01

Last updated by the study team

2008-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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