Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Arkansas
Treatments:
Bortezomib
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.