Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

NCT ID: NCT06028087

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

736 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2030-03-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerio De Stefano

Role: PRINCIPAL_INVESTIGATOR

Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma

Locations

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

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Facility Contacts

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Valerio De Stefano

Role: primary

Other Identifiers

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ET0123

Identifier Type: -

Identifier Source: org_study_id

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