Thrombosis in Patients With Multiple Myeloma in an University Medical Center (THRIMM)

June 29, 2023 updated by: Catalina Codreanu

Thrombosis in Newly Diagnosed Multiple Myeloma Patients: a Clinical Audit of Intermediate Dose Low Molecular Weight Heparin

Main research question:

What is the present venous thrombosis incidence and what are the current practices of prescribing thromboprophylaxis in patients with multiple myeloma (MM)?

Design:

The present study is a retrospective cohort study. The patients will be selected from the electronic patient dossier (EPD) of the University Medical Center Groningen (UMCG). The present study will include newly diagnosed adult patients with a first MM at the UMCG between 1st of January 2014 and 1st of September 2021. The primary outcome of the study is the incidence of venous thromboembolism (VTE) with one year of diagnosis of MM. The investigators will also describe the various thromboprophylaxis regimens used and their corresponding VTE incidence. The secondary outcome will be the incidence of arterial thrombosis (AT) within the same period of time. Possible confounders are the therapy administered for MM, thromboprophylaxis type, age and patient comorbidities. Lastly, the third outcome will be a description of current thromboprophylaxis practices in the UMCG. Each outcome will be described separately.

Expected results:

Based on the study by de Waal et al in which they included 474 MM patients treated at the UMCG and at 4 hospitals in the province Friesland, the investigators expect to record a VTE incidence of approximately 15%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Multiple myeloma (MM) is a neoplastic clonal proliferation of plasma cells causing a considerable worldwide burden of disease. In 2016 Western Europe was one of the regions with the highest MM incidence globally, with an age-standardized incidence of 4.6 per 100.000 (95% UI, 3.7-5.5). MM is associated with multiple complications which make the management of this disease particularly difficult. Moreover, patients with MM have a raised risk of venous thromboembolism (VTE) which substantially increases their mortality risk. The link between malignancy and the development of a hypercoagulable state has been extensively studied, with altered coagulation, patient comorbidities, tumour characteristics and treatment side-effects all playing a role in the pathogenesis of thrombosis in cancer. Specifically in MM, the increased VTE risk seems to be partially due to aberrations in haemostasis, such as acquired activated Protein C resistance and increased levels of Factor VIII and Von Willebrand Factor.

MM treatment and maintenance therapy has developed and improved substantially during the past decades, with immunomodulatory drugs (IMIDs), namely lenalidomide- or thalidomide-based regimens, being currently the most effective and used option. Nevertheless, one of the challenges of these regimens remains the associated elevated VTE risk, which is especially high in newly diagnosed MM patients treated with IMIDs and dexamethasone. Various mechanisms have been researched to explain the increased VTE risk. For instance, transiently decreased thrombomodulin levels during the first months of treatment have been associated with an increased thrombosis risk during the initial period of therapy. Moreover, high levels of cathepsin G have also been hypothesized to contribute to the high thrombosis incidence in MM patients undergoing treatment.

Choosing an appropriate thromboprophylaxis regimen in MM patients treated with IMIDs remains a challenge in clinical practice. Randomized controlled trials (RCTs) did not show a difference in the VTE risk between the use of aspirin or low molecular weight heparin (LMWH) in the management of MM patients. Furthermore, despite thromboprophylaxis, high VTE incidence remains a concerning problem in contemporary lenalidomide-based regimens. Therefore, the current study seeks to describe the use and efficacy of current thromboprophlaxis regimens in MM patients treated with IMIDs in an university medical center in order to assess the current VTE incidence and the effectiveness of thromboprophylaxis protocols in place.

Research question:

What is the present venous thrombosis incidence and what are the current practices of prescribing thromboprophylaxis in patients with multiple myeloma?

Design:

The present study is a retrospective cohort study. The patients will be selected from the electronic patient dossier (EPD) of the University Medical Center Groningen (UMCG). The present study will include newly diagnosed adult patients with a first MM at the UMCG between the 1st of January 2014 and 1st of September 2021. The primary outcome of the study is the incidence of VTE with one year of diagnosis of MM. The investigators will also describe the various thromboprophylaxis regimens used and their corresponding VTE incidence. The secondary outcome will be the incidence of arterial thrombosis (AT) within the same period of time. Possible confounders are the therapy administered for MM, thromboprophylaxis type, age and patient comorbidities. Lastly, the third outcome will be a description of current thromboprophylaxis practices in the UMCG. Each outcome will be described separately.

Expected results:

Based on the study by de Waal et al in which they included 474 MM patients treated at the UMCG and at 4 hospitals in the province Friesland, the investigators expect to record a VTE incidence of approximately 15%.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study seeks to include all available multiple myeloma patients treated in the UMCG. The inclusion of all patients is necessary in order to be able to calculate the incidence of venous thrombosis and in order to describe the use of thromboprophylaxis in these patients. Therefore all UCMG patients qualifying based on the inclusion and exclusion criteria will be included. We approximate that there are 60 new cases of multiple myeloma diagnosed per year in the UMCG. Thus, around 480 patients would be included in the study.

Description

Inclusion Criteria:

  • Adult patients diagnosed with multiple myeloma between 1st of January 2014 and 1st of September 2021
  • Patients diagnosed at UMCG
  • Patients diagnosed with multiple myeloma based on the IMWG criteria

Exclusion Criteria:

  • Patients first diagnosed with multiple myeloma before 1st of January 2014
  • Patients diagnosed after 1st of September 2021
  • Patients diagnosed with a relapse of multiple myeloma between 1st of January 2014 and 1st of September 2021 of a multiple myeloma diagnosed <2014
  • Patients who are marked as objecting to the use of their data for research purposes in the electronic patient dossier of UMCG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous thromboembolism incidence
Time Frame: 1 year
We will calculate the incidence of venous thromboembolism of patients within one year of a first diagnosis of multiple myeloma. The influence of various risk factors will be investigated.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial thromboembolism
Time Frame: 1 year
We will calculate the incidence of arterial thromboembolism of patients within one year of a first diagnosis of multiple myeloma. The influence of various risk factors will be investigated.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of thrombosis events per thromboprophylaxis regimen
Time Frame: 1 year
We will investigate the frequency of thrombosis events per thromboprophylaxis regimen.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalina Codreanu

Investigators

  • Principal Investigator: Karina Meijer, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200311

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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