Multiple MyelomaNCT01132833
Biomarkers Related to Thrombosis in Patients With Newly Diagnosed Multiple Myeloma Receiving Chemotherapy
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism
- What is being tested?
- enzyme-linked immunosorbent assay, laboratory biomarker analysis and medical chart review
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
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.
Read the 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.
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism
- Being tested
- enzyme-linked immunosorbent assay, laboratory biomarker analysis, medical chart review
- Keywords
- thromboembolism, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of circulating tissue factor (TF)
Measured: 5 years
Secondary outcomes (3)
Alteration in coagulation parameters
Measured: 5 years
Correlation of TF with markers of coagulation activation and endothelial activation
Measured: 5 years
Incidence of venous thromboembolism
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2012
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nigel Mackman, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132833
- Sponsor's protocol ID
- LCCC 0802
- Other IDs
- P30CA016086, CDR0000674053
- Status last verified
- Aug 2016
- First submitted
- 27 May 2010
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy and Anti-angiogenic Agents- Induced Thrombosis in Cancer.
- ClinicalTrials.gov ID
- NCT01132833
- Acronym / sponsor ID
- LCCC 0802
- Conditions
- Multiple Myeloma, Plasma Cell Neoplasm, Thromboembolism
- Keywords
- thromboembolism, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed multiple Multiple Myeloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enzyme-linked immunosorbent assayMeasurement of markers of coagulation and endothelial activation | Other | – |
| laboratory biomarker analysisThe PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage | Other | – |
| medical chart reviewThe 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. | Other | – |
Primary outcome
Levels of circulating tissue factor (TF)
Time frame: 5 years
3 secondary outcomes
Alteration in coagulation parameters
Time frame: 5 years
Correlation of TF with markers of coagulation activation and endothelial activation
Time frame: 5 years
Incidence of venous thromboembolism
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- web address for Lineberger Comprehensive Cancer Center, UNCLink provided by the sponsor.
- web address for the National Cancer Institute (NCI)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Mackman, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of circulating tissue factor (TF) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.