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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569868
Recruitment Status : Completed
First Posted : December 10, 2007
Results First Posted : August 12, 2011
Last Update Posted : August 12, 2011
Information provided by:
University of Arkansas

Brief Summary:
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Condition or disease Intervention/treatment Phase
MULTIPLE MYELOMA Drug: Velcade Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Study Start Date : August 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Velcade

Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years.

Each cycle will consist of 3 weeks (21 days) according to the schedule below.

DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles.

Drug: Velcade

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.

Primary Outcome Measures :
  1. Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma. [ Time Frame: 60 days ]

    Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.

    Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute's guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.

    Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569868

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Maurizio Zangari, MD UAMS

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bart Barlogie, MD, PhD, University of Arkansas for Medical Sciences Identifier: NCT00569868     History of Changes
Other Study ID Numbers: 2005-05
First Posted: December 10, 2007    Key Record Dates
Results First Posted: August 12, 2011
Last Update Posted: August 12, 2011
Last Verified: July 2011

Keywords provided by University of Arkansas:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents