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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-01-31

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.

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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.

Conditions

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Multiple Myeloma Plasma Cell Neoplasm Thromboembolism

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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enzyme-linked immunosorbent assay

Measurement of markers of coagulation and endothelial activation

Intervention Type 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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No