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
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Levels of circulating tissue factor (TF) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed multiple Multiple Myeloma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132833

Locations
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
Investigators
Principal Investigator: Nigel Mackman, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01132833     History of Changes
Other Study ID Numbers: LCCC 0802, P30CA016086, CDR0000674053
Study First Received: May 27, 2010
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014