Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01132833|
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : August 22, 2016
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Plasma Cell Neoplasm Thromboembolism||Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Official Title:||Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2016|
- Other: enzyme-linked immunosorbent assay
Measurement of markers of coagulation and endothelial activation
- Other: laboratory biomarker analysis
The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage
- Other: medical chart review
The patient's clinical course with respect to development of venous thromboembolism and response to treatment will be monitored for a total of 3 months from enrollment.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|