ThrombosisNCT03145870
Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
A study testing Echoing of the lower limbs and measuring the systolic pressure index in people with Thrombosis and Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Multiple Myeloma
- What is being tested?
- Echoing of the lower limbs and measuring the systolic pressure index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2014to 16 May 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patient major age ≥18 years
- Patients with symptomatic myeloma meeting the definition of the International Myeloma Working Group, regardless of the therapeutic line, including patients in remission and untreated.
- Patient having given informed consent, signed.
- Patient benefiting from a social security scheme
Who cannot join
- Patients with non-symptomatic myeloma (stage I) or gammapathy of unknown significance (MGUS).
- Patient undergoing antithrombotic treatment for deep or superficial venous thrombosis and / or pulmonary embolism at the time of inclusion.
- Patients with occlusive arterial disease of the lower limbs known at the time of inclusion.
- Minors, protected adults and patients deprived of liberty or not affiliated to a social security scheme
- Pregnant woman
- Patient unable to express consent.
- Patient under guardianship or curatorship or patient deprived of public liberty
Trial locations and contacts
1 site in 1 country.
About this study
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.
The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.
- Conditions
- Thrombosis, Multiple Myeloma
- Being tested
- Echoing of the lower limbs and measuring the systolic pressure index
- Medical subject headings
- Thrombosis, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echoing of the lower limbs and measuring the systolic pressure indexOther
Echoing of the lower limbs and measuring the systolic pressure index
| Study group | Role | What they receive |
|---|---|---|
| Patient with multiple symptomatic myeloma | Other | Not described Receives: Other: Echoing of the lower limbs and measuring the systolic pressure index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start3 Jun 2014
- Primary completion16 May 2017
- Study completion16 May 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145870
- Sponsor's protocol ID
- PI2014_843_0009
- Status last verified
- Jul 2020
- First submitted
- 4 May 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03145870
- Acronym / sponsor ID
- PI2014_843_0009
- Conditions
- Thrombosis, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator choice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 9 May 2017 (actual)
- 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.
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.
The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with multiple symptomatic myeloma | Other | Other: Echoing of the lower limbs and measuring the systolic pressure index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient major age ≥18 years
- Patients with symptomatic myeloma meeting the definition of the International Myeloma Working Group, regardless of the therapeutic line, including patients in remission and untreated.
- Patient having given informed consent, signed.
- Patient benefiting from a social security scheme
Key exclusion criteria (7 listed)
- Patients with non-symptomatic myeloma (stage I) or gammapathy of unknown significance (MGUS).
- Patient undergoing antithrombotic treatment for deep or superficial venous thrombosis and / or pulmonary embolism at the time of inclusion.
- Patients with occlusive arterial disease of the lower limbs known at the time of inclusion.
- Minors, protected adults and patients deprived of liberty or not affiliated to a social security scheme
- Pregnant woman
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 |
|---|---|---|
| Echoing of the lower limbs and measuring the systolic pressure indexEchoing of the lower limbs and measuring the systolic pressure index | Other | Patient with multiple symptomatic myeloma |
Primary outcome
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echoing of the lower limbs and measuring the systolic pressure index in people with Thrombosis and Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 17 Jul 2020. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo (time frame: 1 day). 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 17 Jul 2020.