MDS Clinical Trial
Official title:
Phase II Study of PS341 (VELCADE) in Myelodysplastic Syndromes (MDS). EudraCT Number 2004-002935-23
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | March 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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given voluntary written informed consent to participate in the study, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Istituto di Ematologia e Oncologia Medica L. e A. Seragnoli | Bologna | |
Italy | Ospedale Niguarda "Ca Grande" | Milano | |
Italy | Centro Oncologico Basilicata | Rionero in Vulture | Potenza |
Italy | A.O Umberto I | Roma |
Lead Sponsor | Collaborator |
---|---|
Gruppo Italiano Malattie EMatologiche dell'Adulto |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | to determine activity of Velcade in patients with MDS, intermediate-2 or high risk, and intermediate-1 or low risk unresponsive or not eligible for treatment with erythropoietin or immunosuppressive agents as assessed according to response criteria. | |||
Secondary | to determine whether Velcade prolongs time to progression and/or survival; safety and tolerability as assessed by incidence of clinical and laboratory toxicities; quality of life in relation to neurotoxicity. |
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