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

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ClinicalTrials.gov Identifier: NCT01132833
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : August 22, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Plasma Cell Neoplasm Thromboembolism Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review Phase 1

Detailed Description:



  • 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.


  • 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
Actual Enrollment : 18 participants
Time Perspective: Prospective
Official Title: Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
Study Start Date : December 2008
Primary Completion Date : December 2012
Study Completion Date : January 2016

Intervention Details:
    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.

Primary Outcome Measures :
  1. Levels of circulating tissue factor (TF) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed multiple Multiple Myeloma


  • Newly diagnosed; relapsed, or refractory multiple myeloma


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132833

United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Nigel Mackman, PhD UNC Lineberger Comprehensive Cancer Center

Additional Information:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01132833     History of Changes
Other Study ID Numbers: LCCC 0802
P30CA016086 ( U.S. NIH Grant/Contract )
CDR0000674053 ( Other Identifier: PDQ number )
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Embolism and Thrombosis