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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 May 2021 |
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Main ID: |
NCT03405571 |
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Date of registration:
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12/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Validation of the 4TS RAM in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias.
ROADMAP-MM |
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Scientific title:
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A Prospective Validation of the 4TS Risk Assessment Model in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias. ROADMAP-MM |
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Date of first enrolment:
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June 1, 2014 |
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Target sample size:
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800 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03405571 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Meletios A Dimopoulos, MD |
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Address:
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Telephone:
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0030210 3381540 |
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Email:
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mdimop@med.uoa.gr |
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Affiliation:
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Name:
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Despina Fotiou, MD |
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Address:
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Telephone:
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00306946613774 |
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Email:
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desfotiou@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly Diagnosed patients with symptomatic multiple myeloma
- Previously untreated patients
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Venous Thromboembolism
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Intervention(s)
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Other: No intervention
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Primary Outcome(s)
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Symptomatic venous thromboembolism
[Time Frame: 12 months]
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Secondary Outcome(s)
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Major Bleeding
[Time Frame: 12 months]
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Mortality
[Time Frame: 12 months]
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Disease progression
[Time Frame: 12 months]
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Secondary ID(s)
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ROADMAP-MM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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