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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm, Thromboembolism

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Levels of circulating tissue factor (TF)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Nigel Mackman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0802

NCT ID:

NCT01132833

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • Thromboembolism
  • thromboembolism
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Thromboembolism
  • Thrombosis

Name

Location
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570