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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01132833
Other study ID # LCCC 0802
Secondary ID P30CA016086CDR00
Status Completed
Phase Phase 1
First received May 27, 2010
Last updated August 18, 2016
Start date December 2008
Est. completion date January 2016

Study information

Verified date August 2016
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 2016
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Intervention

Other:
enzyme-linked immunosorbent assay
Measurement of markers of coagulation and endothelial activation
laboratory biomarker analysis
The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage
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.

Locations

Country Name City State
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of circulating tissue factor (TF) 5 years No
Secondary Alteration in coagulation parameters 5 years No
Secondary Correlation of TF with markers of coagulation activation and endothelial activation 5 years No
Secondary Incidence of venous thromboembolism 5 years No
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