Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm, Thromboembolism
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 |
