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


N/A
18 Years
N/A
Not Enrolling
Both
MULTIPLE MYELOMA

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.

Outcome Description:

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.

Outcome Time Frame:

60 days

Safety Issue:

No

Principal Investigator

Maurizio Zangari, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UAMS

Authority:

United States: Institutional Review Board

Study ID:

2005-05

NCT ID:

NCT00569868

Start Date:

August 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • PLASMACYTOMA
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205