Trial Information
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
change from baseline in Thrombin generation measure
Outcome Description:
change from baseline in Thrombin generation measure
Outcome Time Frame:
day 21
Safety Issue:
No
Principal Investigator
Bernard TARDY, MD-PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU de Saint-Etienne - CIC-EC (CIE3)
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
1108178
NCT ID:
NCT01508416
Start Date:
January 2012
Completion Date:
June 2013
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Newly diagnosed
- Thrombin generation
- TFPI
- Tissue Factor pathway inhibitor
- Protein S
- Thrombosis
- Chemotherapy
- Multiple Myeloma
- Neoplasms, Plasma Cell