N/A
Completed N=11
UARK 2005-05, Coagulation-Related Effects of Velcade Treatment in Patients With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT00569868 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.
Summary
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma. |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00569868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.