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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Thromboembolism; Multiple Myeloma; Plasma Cell Neoplasm

Treatments: Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay; Other: medical chart review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01132833

CDR0000674053 (Other Identifier)

LCCC 0802

P30CA016086 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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