Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Recruiting

• Conditions: Multiple Myeloma; Diagnosis

• Registration Number: NCT06028087
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).

Detailed Description

This is an observational prospective cohort study aimed at assessing the efficacy of different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of the Italian haematological Centers.

The observation time for each patient will be of 3 years from the start of the active treatment for MM. Patients will remain in the study regardless of the stage of disease, type of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis, occurrence of thrombosis.

Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis, cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

1. Age equal to or greater than 18 years of age.
2. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group
3. First active treatment for MM started after recruitment in the study
4. Signed informed consent

Exclusion Criteria

1. Patients having had thrombosis within 6 months before diagnosis of MM
2. Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)
3. Ongoing first active treatment for MM initiated before the starting of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of venous thromboembolism according to different thromboprophylaxis strategies	3 years	Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed: 1. Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis; 2. Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis; 3. Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia; 🇮🇹 Roma, Italy