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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.
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.
Maurizio Zangari, MD
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|