Velcade in Myelodysplastic Syndrome - Pilot Study

NCT00440076 | Terminated Phase 2

• 1 other identifier: MDS0104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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 GIMEMA Data Center before therapy starts and after inclusion criteria verification.

Conditions

MDS

Keywords

MDS; Velcade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Velcade DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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given voluntary written informed consent to participate in the study, with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (4)

Istituto di Ematologia e Oncologia Medica L. e A. Seragnoli

Bologna, Bologna, Italy

Location

Ospedale Niguarda "Ca Grande"

Milan, Milano, Italy

Location

Centro Oncologico Basilicata

Rionero in Vulture, Potenza, Italy

Location

A.O Umberto I

Roma, Roma, Italy

Location

MeSH Terms

Interventions

Bortezomib

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Giuliana ALIMENA, MD, PHD

  Università degli Studi di Roma "La Sapienza", Dipartimento di Biotecnologie Cellulari ed Ematolgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 26, 2007
• Study Start: August 1, 2006
• Study Completion: March 1, 2008
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

IT (4)