Clinical trial · Observational
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
- 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)
Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy. Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk. The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with Multiple Myeloma
- description
- Patients with newly diagnosed Multiple Myeloma required chemotherapy
Primary outcomes (4)
- measure
- change from baseline in Thrombin generation measure
- timeFrame
- day 21
- description
- change from baseline in Thrombin generation measure
- measure
- change from baseline in Thrombin generation measure
- timeFrame
- day 42
- description
- change from baseline in Thrombin generation measure
- measure
- change from baseline in Thrombin generation measure
- timeFrame
- day 63
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inscription to medical assurance * Patients who gave their written consent * Patients with newly diagnosed Multiple Myeloma required chemotherapy Exclusion Criteria: * Patients with renal failure who need to undergo hemodialysis * Patients with indication for curative anticoagulant therapy * Patient with 3 month follow-up not possible * Patient with life expectancy \< 6 month
References
Publications (1)
- DERIVEDCharles S, Fatrara T, Bouriche T, Bonifay A, Lecompte T, Dignat-George F, Tardy B, Frere C, Lacroix R, Chalayer E. Tissue factor-bearing extracellular vesicles, procoagulant phospholipids and D-dimer as potential biomarkers for venous thromboembolism in patients with newly diagnosed multiple myeloma: A comprehensive analysis. Thromb Res. 2025 Mar;247:109256. doi: 10.1016/j.thromres.2025.109256. Epub 2025 Jan 10. PMID 39823789