Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Diagnosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Primary outcome measures
- Rate of venous thromboembolism according to different thromboprophylaxis strategies [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia — Roma
Identifiers
NCT: NCT06028087 · ET0123