Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how patients respond to treatment.
PURPOSE: This research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.
|Multiple Myeloma Plasma Cell Neoplasm Thromboembolism||Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review||Phase 1|
|Study Design:||Time Perspective: Prospective|
|Official Title:||Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.|
- Levels of circulating tissue factor (TF) [ Time Frame: 5 years ]
- Alteration in coagulation parameters [ Time Frame: 5 years ]
- Correlation of TF with markers of coagulation activation and endothelial activation [ Time Frame: 5 years ]
- Incidence of venous thromboembolism [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 2008|
|Study Completion Date:||January 2016|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Other: enzyme-linked immunosorbent assay
- To measure levels of circulating tissue factor (TF) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents.
- To measure the correlation of TF with two markers of coagulation activation (i.e., D-dimer, thrombin-antithrombin [TAT] complexes) and two markers of endothelial activation (i.e., soluble E-selectin, soluble thrombomodulin) in these patients.
- To measure and compare (descriptively) our microparticle-associated TF procoagulant activity assay with two other assays using samples from these patients.
OUTLINE: Patients undergo blood sample collection at baseline and then periodically during treatment. Circulating tissue factor (TF) activity levels and coagulation and endothelial activation (by ELISA) are measured. Medical charts are reviewed for sociodemographic and medical information.
After completion of study, patients are followed up for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132833
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Nigel Mackman, PhD||UNC Lineberger Comprehensive Cancer Center|