Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06028087

Enrollment

736

Registered

2023-09-07

Start date

2025-03-10

Completion date

2030-03-31

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Multiple Myeloma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it0670390528

Backup ContactEnrico Crea

e.crea@gimema.it0670390514

Outcome results