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NCT Number: NCT06028087

Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia

Roma, Italy

Location status: Recruiting

Location contact

Valerio De Stefano

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Rate of venous thromboembolism according to different thromboprophylaxis strategies

    Time frame: 3 years

    Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed:

    • Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis
    • Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis
    • Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

0670390514

Paola Fazi

CONTACT

[email protected]

0670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 7, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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