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

UNC Lineberger Comprehensive Cancer Center18 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Myeloma Plasma Cell Neoplasm Thromboembolism

Interventions

enzyme-linked immunosorbent assayOTHER

Measurement of markers of coagulation and endothelial activation

laboratory biomarker analysisOTHER

The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage

medical chart reviewOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Newly diagnosed; relapsed, or refractory multiple myeloma PATIENT CHARACTERISTICS: * Central venous access devices allowed * Recruited by the Division of Hematology/Oncology and the Lineberger Comprehensive Cancer Center at the University of North Carolina * No history of venous thromboembolism * No hospitalization for \> 2 days within the past month * Not pregnant * No patient who refuses or is deemed unsuitable for chemotherapy PRIOR CONCURRENT THERAPY: * No surgery within the past month * Bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed * \* No concurrent anticoagulation therapy * Concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Levels of circulating tissue factor (TF)

Time frame: 5 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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