Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

NCT ID: NCT03145870

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-03
• Study Completion Date: 2017-05-16

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.

Conditions

Thrombosis; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with multiple symptomatic myeloma

Group Type: OTHER

Echoing of the lower limbs and measuring the systolic pressure index

Intervention Type: OTHER

Echoing of the lower limbs and measuring the systolic pressure index

Interventions

Echoing of the lower limbs and measuring the systolic pressure index

Echoing of the lower limbs and measuring the systolic pressure index

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2014_843_0009

Identifier Type: -

Identifier Source: org_study_id