Thrombosis in Patients With Multiple Myeloma in an University Medical Center

NCT05541978 | Completed

• 1 other identifier: 202200311
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Multiple Myeloma; Venous Thromboembolism; Arterial Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Venous thromboembolism incidence

  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 Outcomes (1)

• Arterial thromboembolism

  1 year

Other Outcomes (1)

• Frequency of thrombosis events per thromboprophylaxis regimen

  1 year

Interventions

Multiple myeloma OTHER

We will explore the multiple myeloma associated thrombosis risk.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catalina Codreanu: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (18)

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  BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• Karina Meijer

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master student, Medicine

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: September 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

NL (1)