NCT03405571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

6.1 years

First QC Date

January 12, 2018

Last Update Submit

April 27, 2021

Conditions

Multiple MyelomaVenous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Symptomatic venous thromboembolism

    Symptomatic objectively confirmed venous thromboembolism

    12 months

Secondary Outcomes (3)

  • Mortality

    12 months

  • Major Bleeding

    12 months

  • Disease progression

    12 months

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Newly Diagnosed patients with symptomatic multiple myeloma
  • Previously untreated patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandra Hospital , Department of Clinical Therapeutics

Athens, Attica, 115 28, Greece

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaVenous Thromboembolism

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesThromboembolismEmbolism and Thrombosis

Central Study Contacts

Despina Fotiou, MD

CONTACT

00306946613774desfotiou@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MA Dimopoulos

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

June 1, 2014

Primary Completion

June 30, 2020

Study Completion

June 30, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)