Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

LCCC 0802


NCT ID:

NCT01132833


Secondary ID:

P30CA016086


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

UNC Lineberger Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Nigel Mackman, PhD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center

Study Dates

Start Date:December 2008
Completion Date:January 2016
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 18, 2016
First Received Date:May 27, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Levels of circulating tissue factor (TF)
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Alteration in coagulation parameters
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Correlation of TF with markers of coagulation activation and endothelial activation
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of venous thromboembolism
Time Frame:5 years
Safety Issues:False

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:UNC Lineberger Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood samples
Study Population: Patients diagnosed multiple Multiple Myeloma
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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