Clinical Trial: UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary: To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Detailed Summary:
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.
Sponsor: University of Arkansas
Current Primary Outcome: 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.
Original Primary Outcome: Changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time. [ Time Frame: 60 days ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Arkansas
Dates:
Date Received: December 7, 2007
Date Started: August 2005
Date Completion:
Last Updated: July 18, 2011
Last Verified: July 2011
