Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028087
• Other study ID #: ET0123
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2028

Study information

• Verified date: August 2023
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: 0670390528
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 736
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of venous thromboembolism according to different thromboprophylaxis strategies	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.	3 years