MedTrace Logo

Validation of the 4TS RAM in the Prevention of Venous Thromboembolism in Patients With Plasma Cell Dyscrasias.

NCT03405571 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Pierre and Marie Curie University

    collaborator OTHER

  • University of Athens

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2020-06-30
Completion
2022-06-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03405571 on ClinicalTrials.gov