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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01132833
First received: May 27, 2010
Last updated: December 2, 2013
Last verified: December 2013

May 27, 2010
December 2, 2013
December 2008
June 2014   (final data collection date for primary outcome measure)
Levels of circulating tissue factor (TF) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Levels of circulating tissue factor (TF) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132833 on ClinicalTrials.gov Archive Site
  • Alteration in coagulation parameters [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Correlation of TF with markers of coagulation activation and endothelial activation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of venous thromboembolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Alteration in coagulation parameters [ Designated as safety issue: No ]
  • Correlation of TF with markers of coagulation activation and endothelial activation [ Designated as safety issue: No ]
  • Incidence of venous thromboembolism [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

Patients diagnosed multiple Multiple Myeloma

  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Thromboembolism
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2018
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01132833
LCCC 0802, P30CA016086, CDR0000674053
No
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Nigel Mackman, PhD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP