Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

Not Applicable

Withdrawn

• Conditions: Multiple Myeloma; Thrombosis
• Interventions: Other: Echoing of the lower limbs and measuring the systolic pressure index

• Registration Number: NCT03145870
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-03
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with multiple symptomatic myeloma	Echoing of the lower limbs and measuring the systolic pressure index	-

Primary Outcome Measures

Name	Time	Method
Analysis of the occurrence of venous thromboembolic events via transverse Doppler echo	1 day

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France