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OpenTrials
Completed

NCT Number: NCT01132833

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chapel Hill, North Carolina, 27599-7295, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enzyme-linked immunosorbent assay

Other

Measurement of markers of coagulation and endothelial activation

laboratory biomarker analysis

Other

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

medical chart review

Other

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.

Primary outcomes

  1. Levels of circulating tissue factor (TF)

    Time frame: 5 years

Secondary outcomes

  1. Alteration in coagulation parameters

    Time frame: 5 years

  2. Correlation of TF with markers of coagulation activation and endothelial activation

    Time frame: 5 years

  3. Incidence of venous thromboembolism

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2016
First posted
May 28, 2010
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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