Clinical trial · Observational
Thrombosis in Patients With Multiple Myeloma in an University Medical Center
Thrombosis in Newly Diagnosed Multiple Myeloma Patients: a Clinical Audit of Intermediate Dose Low Molecular Weight Heparin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arterial Thromboembolism | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple myeloma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Venous thromboembolism incidence
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
- measure
- Arterial thromboembolism
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDCowan AJ, Allen C, Barac A, Basaleem H, Bensenor I, Curado MP, Foreman K, Gupta R, Harvey J, Hosgood HD, Jakovljevic M, Khader Y, Linn S, Lad D, Mantovani L, Nong VM, Mokdad A, Naghavi M, Postma M, Roshandel G, Shackelford K, Sisay M, Nguyen CT, Tran TT, Xuan BT, Ukwaja KN, Vollset SE, Weiderpass E, Libby EN, Fitzmaurice C. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018 Sep 1;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128. PMID 29800065
- BACKGROUNDKristinsson SY, Pfeiffer RM, Bjorkholm M, Goldin LR, Schulman S, Blimark C, Mellqvist UH, Wahlin A, Turesson I, Landgren O. Arterial and venous thrombosis in monoclonal gammopathy of undetermined significance and multiple myeloma: a population-based study. Blood. 2010 Jun 17;115(24):4991-8. doi: 10.1182/blood-2009-11-252072. Epub 2010 Mar 18. PMID 20299513
- BACKGROUNDSchoen MW, Carson KR, Luo S, Gage BF, Li A, Afzal A, Sanfilippo KM. Venous thromboembolism in multiple myeloma is associated with increased mortality. Res Pract Thromb Haemost. 2020 Sep 25;4(7):1203-1210. doi: 10.1002/rth2.12411. eCollection 2020 Oct. PMID 33134785
- BACKGROUNDFalanga A, Donati MB. Pathogenesis of thrombosis in patients with malignancy. Int J Hematol. 2001 Feb;73(2):137-44. doi: 10.1007/BF02981929. PMID 11372723
- BACKGROUNDDe Cicco M. The prothrombotic state in cancer: pathogenic mechanisms. Crit Rev Oncol Hematol. 2004 Jun;50(3):187-96. doi: 10.1016/j.critrevonc.2003.10.003. PMID 15182825
- BACKGROUNDColombo R, Gallipoli P, Castelli R. Thrombosis and hemostatic abnormalities in hematological malignancies. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):441-50. doi: 10.1016/j.clml.2014.05.003. Epub 2014 Jun 11. PMID 25018062
- BACKGROUNDAuwerda JJ, Sonneveld P, de Maat MP, Leebeek FW. Prothrombotic coagulation abnormalities in patients with newly diagnosed multiple myeloma. Haematologica. 2007 Feb;92(2):279-80. doi: 10.3324/haematol.10454.