Clincosm LogoSign in Get a demo

Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06028087
Collaborator
(none)
736
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    736 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2028
    Anticipated Study Completion Date :
    Dec 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. 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: 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gruppo Italiano Malattie EMatologiche dell'Adulto

    Investigators

    • Principal Investigator: Valerio De Stefano, Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    ClinicalTrials.gov Identifier:
    NCT06028087
    Other Study ID Numbers:
    • ET0123
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Sep 7, 2023