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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01132833

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Plasma Cell Neoplasm Thromboembolism	Other: enzyme-linked immunosorbent assay Other: laboratory biomarker analysis Other: medical chart review

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.

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jan 1, 2016

Outcome Measures

Primary Outcome Measures

Levels of circulating tissue factor (TF) [5 years]

Secondary Outcome Measures

Alteration in coagulation parameters [5 years]
Correlation of TF with markers of coagulation activation and endothelial activation [5 years]
Incidence of venous thromboembolism [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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