NCT01508416

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

December 15, 2011

Last Update Submit

July 27, 2015

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaNewly diagnosedThrombin generationTFPITissue Factor pathway inhibitorProtein SThrombosisChemotherapy

Outcome Measures

Primary Outcomes (4)

  • change from baseline in Thrombin generation measure

    change from baseline in Thrombin generation measure

    day 21

  • change from baseline in Thrombin generation measure

    change from baseline in Thrombin generation measure

    day 42

  • change from baseline in Thrombin generation measure

    change from baseline in Thrombin generation measure

    day 63

  • change from baseline in Thrombin generation measure

    change from baseline in Thrombin generation measure

    day 0

Secondary Outcomes (9)

  • image-confirmed venous thromboembolic events

    day 63

  • change from baseline in TFPI resistance measure

    day 21

  • change from baseline in acquired protein S deficiency measure

    day 21

  • change from baseline in TFPI resistance measure

    day 42

  • change from baseline in TFPI resistance measure

    day 63

  • +4 more secondary outcomes

Study Arms (1)

Patients with Multiple Myeloma

Patients with newly diagnosed Multiple Myeloma required chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with newly diagnosed Multiple Myeloma required chemotherapy

You may qualify if:

  • Inscription to medical assurance
  • Patients who gave their written consent
  • Patients with newly diagnosed Multiple Myeloma required chemotherapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Nancy

Nancy, 54000, France

Location

Service de Médecine Interne - CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Service de rhumatologie - CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Service d'hématologie - ICL

Saint-Priest-en-Jarez, 42270, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and serum

MeSH Terms

Conditions

Multiple MyelomaThrombosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesEmbolism and Thrombosis

Study Officials

  • Bernard TARDY, MD-PhD

    CHU de Saint-Etienne - CIC-EC (CIE3)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

January 12, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

FR(5)