Back to resultsPrevalence of Asymptomatic Thrombosis in Multiple Myeloma
Primary Purpose
Thrombosis, Multiple Myeloma
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echoing of the lower limbs and measuring the systolic pressure index
Sponsored by
About this trial
This is an interventional other trial for Thrombosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with multiple symptomatic myeloma
Arm Description
Outcomes
Primary Outcome Measures
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo
Secondary Outcome Measures
Full Information
NCT ID
NCT03145870
First Posted
May 4, 2017
Last Updated
July 15, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03145870
Brief Title
Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
Official Title
Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
investigator choice
Study Start Date
June 3, 2014 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
May 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Multiple Myeloma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with multiple symptomatic myeloma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Echoing of the lower limbs and measuring the systolic pressure index
Intervention Description
Echoing of the lower limbs and measuring the systolic pressure index
Primary Outcome Measure Information:
Title
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
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Prevalence of Asymptomatic Thrombosis in Multiple Myeloma
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