NCT01132833

Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy

Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Multiple Myeloma
• Plasma Cell Neoplasm
• Thromboembolism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-12-01
• Completion: 2016-01-01
• First posted: 2010-05-28
• Last updated: 2016-08-22

Locations

1 site across 1 country: United States