Study of Velcade and Thalidomide in Patients With Myelodysplasia

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Bortezomib; Thalidomide

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
• ALT and AST
• 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