Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT01508416
• Date of registration: 15/12/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Public title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma METRO
• Scientific title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
• Date of first enrolment: January 2012
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01508416
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bernard TARDY, MD-PhD
• Affiliation: CHU de Saint-Etienne - CIC-EC (CIE3)

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Primary Outcome(s)

change from baseline in Thrombin generation measure [Time Frame: day 0]

change from baseline in Thrombin generation measure [Time Frame: day 21]

change from baseline in Thrombin generation measure [Time Frame: day 63]

change from baseline in Thrombin generation measure [Time Frame: day 42]

Secondary Outcome(s)

change from baseline in acquired protein S deficiency measure [Time Frame: day 42]

change from baseline in acquired protein S deficiency measure [Time Frame: day 0]

change from baseline in TFPI resistance measure [Time Frame: day 21]

change from baseline in TFPI resistance measure [Time Frame: day 63]

change from baseline in TFPI resistance measure [Time Frame: day 0]

change from baseline in TFPI resistance measure [Time Frame: day 42]

image-confirmed venous thromboembolic events [Time Frame: day 63]

change from baseline in acquired protein S deficiency measure [Time Frame: day 21]

change from baseline in acquired protein S deficiency measure [Time Frame: day 63]

Secondary ID(s)

1108178

2011- A01529-32

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Groupe de Recherche sur la Thrombose

Institut de Cancérologie de la Loire