Velcade in Myelodysplastic Syndrome - Pilot Study

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a four-center open-label study designed to determine activity of Velcade in Myelodysplastic Syndrome (MDS) patients. A total of 28 subjects will be enrolled. The patients will be registered to GIMEMA Data Center before therapy starts and after inclusion criteria verification.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Patients aged 18 -75 years.

• Patients with the following clinical diagnosis: RA(FAB) or RCMD (WHO), RARS (FAB) or RCDM-RS(WHO), RAEB (FAB) or RAEB I (WHO), RAEB II (WHO), and:

• IPSS intermediate-2 (score 1.5-2) or high (score 2.5-3) not previously treated with chemotherapy (CT) and not eligible for intensive chemotherapy or allogeneic stem cell transplantation (SCT), or

• IPSS intermediate-1(score 0.5-1) or low (score 0), EPO or immunosuppressive (Cyclosporine, CSA; anti-tymocyte globulin, ATG) therapies resistant or not eligible for these therapies, and transfusion dependent.

• Patients willing and able to comply with the protocol requirements.

• Patients given voluntary written informed consent to participate in the study, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.

• Male and female patients willing to use acceptable methods for contraception, for the duration of the study.

• Patients with WHO performance Status (PS) 0-2, and life expectancy > 3 months.

• Renal function tests ≤ 2 x upper limit of normal values.

• AST/GOT, ALT/GPT ≤ 2.5 x upper limit of normal values.

• Total bilirubine ≤ 1.5 x upper limit of normal value.

Exclusion Criteria:

• Patient has Grade 2 (as defined by the NCI Common Toxicity Criteria-CTC) peripheral neuropathy within 14 days before enrollment.

• Patient has hypersensitivity to bortezomib, boron or mannitol.

• Patient has received prior treatment with bortezomib

• Patient is pregnant or nursing

• Patient has received other investigational drugs within 14 days before enrollment

• Patient has received prior chemotherapy

• Patient had a major surgery within 4 weeks before enrollment

• Patient had myocardial infarction within 6 months of enrollment or has class III-IV heart failure, uncontrolled angina or arrhythmias

• Patient has been treated for previous malignancy within 5 years before enrollment

• Patient has uncontrolled hypertension or diabetes mellitus

• Patient is known to have HBV or HCV active hepatitis or is human immunodeficiency virus (HIV)-positive

• Patient has systemic infections requiring treatment