Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03145870
• Other study ID #: PI2014_843_0009
• Status: Withdrawn
• Phase: N/A
• Start date: June 3, 2014
• Est. completion date: May 16, 2017

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Thrombosis

Intervention

Other:
• Echoing of the lower limbs and measuring the systolic pressure index
Echoing of the lower limbs and measuring the systolic pressure index

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo		1 day