Study of Velcade and Thalidomide in Patients With Myelodysplasia

NCT00271804 | Terminated Phase 1

• 1 other identifier: 04-381
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic syndrome; Myelodysplasia; MDS; Velcade; Thalidomide; Bortezomib

Outcome Measures

Primary Outcomes (1)

• The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.

Secondary Outcomes (3)

• Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.

• Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.

• Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.

Interventions

bortezomib DRUG

Eligibility Criteria

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

You may qualify if:

• 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 \</+ 2xULN
• ALT and AST \</+ 3xULN
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

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

Study Officials

• Karen Ballen, M

  Massachusetts General Hospital, Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 4, 2006
• Study Start: June 1, 2005
• Study Completion: April 1, 2007
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

US (3)