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



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Cardiology, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2008
End Date:December 2018

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

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.

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
We found this trial at
1
site
101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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mi
from
Chapel Hill, NC
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