Mapping antithrombotic regimens in Multiple Myeloma patients
Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
This study looks at how different blood-thinning treatments help prevent blood clots in people with Multiple Myeloma over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 736 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06028087 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of various thromboprophylaxis methods in patients diagnosed with Multiple Myeloma. It will track patients over a three-year period, categorizing them into four cohorts based on the type of antithrombotic regimen they receive: no prophylaxis, antiplatelet agents, heparins, or oral anticoagulants. The study will take place within the GIMEMA network of Italian hematological centers, allowing for a comprehensive evaluation of real-world treatment outcomes. Patients will be monitored regardless of their disease stage or treatment type.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a new diagnosis of symptomatic Multiple Myeloma and are starting their first active treatment.
Not a fit: Patients who have experienced thrombosis within the last six months or are currently undergoing treatment initiated before the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective thromboprophylaxis strategies for Multiple Myeloma patients, potentially reducing the incidence of venous thromboembolism.
How similar studies have performed: While this study focuses on real-world mapping, similar observational studies have shown promise in understanding treatment efficacy in hematological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Valerio De Stefano — Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.