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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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ClinicalTrials.gov Identifier: NCT03405571
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Pierre and Marie Curie University
Information provided by (Responsible Party):
Meletios A. Dimopoulos, University of Athens

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 risk factors for venous thromboembolism (VTE) in these patients as well as possible biomarkers of hypercoagulability linked with the occurrence of venous thromboembolism at diagnosis and during the disease course. The purpose is to create a risk assessment model for VTE in newly diagnosed multiple myeloma patients and make the model more accurate by combining relevant clinical and disease characteristics with biomarkers of cellular and plasma hypercoagulability. A standardized clinical research form is completed for all patients at baseline, 3, 6 and 12 month follow up to include relevant clinical, patient-related, disease-related and treatment related data. Blood sampling also takes place at baseline and 3,6,12 months to assess multiple biomarkers of plasma and cellular hypercoagulability. In addition lowe limb ultrasound is performed at baseline, 6 and 12 months. The primary endpoint is VTE occurrence. Following the elaboration of the ROADMAP-CAT-MM risk assessment model we will prospectively validate it. 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 during the follow-up. The prospective validation of the ROADMAP-CAT-MM will provide guidance for the use and choice of thromboprophylaxis in these patients and will identify high risk patients eligible for thromboprophylaxis with low molecular weight heparin (tinzaparin).

In addition to symptomatic patients with multiple myeloma the study aims to investigate VTE risk in all plasma cell dyscrasias and will recruit patients with monoclonal gammopathy of undetermined significance, asymptomatic multiple myeloma, primary amyloidosis and Waldenström's macroglobulinemia.


Condition or disease Intervention/treatment
Multiple Myeloma Venous Thromboembolism Other: No intervention

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Validation of the 4TS Risk Assessment Model in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias. ROADMAP-MM
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Symptomatic venous thromboembolism [ Time Frame: 12 months ]
    Symptomatic objectively confirmed venous thromboembolism


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 months ]
    deaths per 1000 persons per year

  2. Major Bleeding [ Time Frame: 12 months ]
    major bleeding event

  3. Disease progression [ Time Frame: 12 months ]
    Progressive disease based on the international myeloma working group criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed, treatment naïve patients with MM recruited from the outpatient Hematology and Oncology Unit of the Clinical Therapeutics Department (Alexandra Hospital, Athens, Greece)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405571


Contacts
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Contact: Despina Fotiou, MD 00306946613774 desfotiou@gmail.com

Locations
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Greece
Alexandra Hospital , Department of Clinical Therapeutics Recruiting
Athens, Attica, Greece, 115 28
Contact: Meletios A Dimopoulos, MD    0030210 3381540    mdimop@med.uoa.gr   
Contact: Maria Gavriatopoulou, MD    0030210 3381556    mgavriat@med.uoa.gr   
Principal Investigator: Meletios A Dimopoulos, MD         
Sub-Investigator: Efstathios Kastritis, MD         
Sub-Investigator: Maria Roussou, MD         
Sponsors and Collaborators
University of Athens
Pierre and Marie Curie University

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Responsible Party: Meletios A. Dimopoulos, Professor MA Dimopoulos, University of Athens
ClinicalTrials.gov Identifier: NCT03405571    
Other Study ID Numbers: ROADMAP-MM
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Thromboembolism
Venous Thromboembolism
Paraproteinemias
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Embolism and Thrombosis