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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism

Intervention / Treatment
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* Other: enzyme-linked immunosorbent assay
* Other: laboratory biomarker analysis
* Other: medical chart review


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of circulating tissue factor (TF) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in coagulation parameters |  | 5 years | 
| Correlation of TF with markers of coagulation activation and endothelial activation |  | 5 years | 
| Incidence of venous thromboembolism |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboembolism, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma