Status:
TERMINATED
Velcade in Myelodysplastic Syndrome - Pilot Study
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
MDS
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
The Myelodysplastic Syndromes (MDS) are an heterogeneous group of clonal disorders of the hematopoietic stem cell characterized by ineffective hematopoiesis leading to peripheral cytopenias, and varia...
Eligibility Criteria
Inclusion
- 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given voluntary written informed consent to participate in the study, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00440076
Start Date
August 1 2006
End Date
March 1 2008
Last Update
April 23 2015
Active Locations (4)
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1
Istituto di Ematologia e Oncologia Medica L. e A. Seragnoli
Bologna, Bologna, Italy
2
Ospedale Niguarda "Ca Grande"
Milan, Milano, Italy
3
Centro Oncologico Basilicata
Rionero in Vulture, Potenza, Italy
4
A.O Umberto I
Roma, Roma, Italy