Status:
UNKNOWN
Validation of the 4TS RAM in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias.
Lead Sponsor:
University of Athens
Collaborating Sponsors:
Pierre and Marie Curie University
Conditions:
Multiple Myeloma
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Brief Summary
Patients with newly diagnosed symptomatic multiple myeloma per IMWG criteria prior to therapy initiation are enrolled in the study. The aim of the study is to investigate clinical and disease related ...
Detailed Description
Hypothesis: We expect that patients who are classified, as high risk according to the ROADMAP-CAT-MM will experience symptomatic VTE more frequently and will have higher morbidity and mortality rates ...
Eligibility Criteria
Inclusion
- Newly Diagnosed patients with symptomatic multiple myeloma
- Previously untreated patients
Exclusion
- Age younger than 18 years
- Life expectancy less than 6 months
- Ongoing pregnancy, major psychiatric disorders
- Recent (\<6 months) episode of VTE or acute coronary syndrome
- Active anticoagulant treatment (for any indication)
- Scheduled open elective curative surgery under general anesthesia for abdominal or pelvic or lung cancer last 3 months
- Hospitalization due to stroke or acute coronary syndrome or congestive heart failure or acute respiratory failure the last 3 months
- Eligible patients had not undergone any surgery in the preceding 3 months.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03405571
Start Date
June 1 2014
End Date
June 30 2022
Last Update
April 28 2021
Active Locations (1)
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1
Alexandra Hospital , Department of Clinical Therapeutics
Athens, Attica, Greece, 115 28