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

• 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 ]

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.

Patients diagnosed multiple Multiple Myeloma

• Multiple Myeloma and 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.

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