Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Multiple Myeloma; Diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT06028087

ET0123

Details and patient eligibility

About

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).

Full 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.

Enrollment: 736 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.