UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00569868

Purpose

The main goal of this study is to evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Condition	Intervention
Multiple Myeloma	Drug: Velcade

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Bortezomib BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.

The platelet Aggregation Test will be done only if Platelet count is 100 000.

Detailed Description:

Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.

Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.

Exclusion Criteria:

Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
Von Willebrand disease, inherited platelet abnormalities.
Familiar history of hypercoagulable state.
Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569868

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Maurizio Zangari, MD

UAMS

More Information

Myeloma Institute for Research and Therapy This link exits the ClinicalTrials.gov site

Responsible Party:	University of Arkansas for Medical Sciences ( Maurizio Zangari, MD )
Study ID Numbers:	2005-05
Study First Received:	December 7, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00569868
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

PLASMACYTOMA

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Plasmacytoma
Plasmacytoma anaplastic
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009