NCT01132833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

May 27, 2010

Last Update Submit

August 18, 2016

Conditions

Multiple MyelomaPlasma Cell NeoplasmThromboembolism

Keywords

thromboembolismstage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Levels of circulating tissue factor (TF)

    5 years

Secondary Outcomes (3)

  • 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

Interventions

enzyme-linked immunosorbent assayOTHER

Measurement of markers of coagulation and endothelial activation

laboratory biomarker analysisOTHER

The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage

medical chart reviewOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed multiple Multiple Myeloma

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellThromboembolism

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Immunoenzyme TechniquesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Nigel Mackman, PhD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

December 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2016

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

US(1)