Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism
Conditions
Keywords
thromboembolism, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
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.
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.
Interventions
OTHERenzyme-linked immunosorbent assay
Measurement of markers of coagulation and endothelial activation
OTHERlaboratory biomarker analysis
The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage
OTHERmedical 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.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of circulating tissue factor (TF) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of TF with markers of coagulation activation and endothelial activation | 5 years |
| Incidence of venous thromboembolism | 5 years |
| Alteration in coagulation parameters | 5 years |
Countries
United States
Outcome results
None listed