Multiple MyelomaMETRONCT01508416
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 71 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed Multiple Myeloma required chemotherapy
Who may be able to join
- Inscription to medical assurance
- Patients who gave their written consent
- Patients with newly diagnosed Multiple Myeloma required chemotherapy
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Clermont Ferrand
Clermont-Ferrand, 63000
CHU de Nancy
Nancy, 54000
Service de Médecine Interne - CHU de Saint Etienne
Saint-Etienne, 42055
Service de rhumatologie - CHU de Saint Etienne
Saint-Etienne, 42055
Service d'hématologie - ICL
Saint-Priest-en-Jarez, 42270
About this study
Official title: Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
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
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Newly diagnosed, Thrombin generation, TFPI, Tissue Factor pathway inhibitor, Protein S, Thrombosis, Chemotherapy
- Medical subject headings
- Multiple Myeloma, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Myeloma | Patients with newly diagnosed Multiple Myeloma required chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Measured: day 21
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Measured: day 42
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Measured: day 63
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Measured: day 0
Secondary outcomes (9)
image-confirmed venous thromboembolic events
Estimate the incidence of venous thromboembolic events until day 63
Measured: day 63
change from baseline in TFPI resistance measure
change from baseline in TFPI resistance measure
Measured: day 21
change from baseline in acquired protein S deficiency measure
change from baseline in acquired protein S deficiency measure
Measured: day 21
change from baseline in TFPI resistance measure
change from baseline in TFPI resistance measure
Measured: day 42
change from baseline in TFPI resistance measure
change from baseline in TFPI resistance measure
Measured: day 63
change from baseline in acquired protein S deficiency measure
change from baseline in acquired protein S deficiency measure
Measured: day 42
change from baseline in acquired protein S deficiency measure
change from baseline in acquired protein S deficiency measure
Measured: day 63
change from baseline in TFPI resistance measure
change from baseline in TFPI resistance measure
Measured: day 0
change from baseline in acquired protein S deficiency measure
change from baseline in acquired protein S deficiency measure
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire, Groupe de Recherche sur la Thrombose
- Responsible party
- Sponsor
- Investigators
- Bernard TARDY, MD-PhD, Principal investigator, CHU de Saint-Etienne - CIC-EC (CIE3)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508416
- Sponsor's protocol ID
- 1108178
- Other IDs
- 2011- A01529-32
- Acronym
- METRO
- Status last verified
- Jul 2015
- First submitted
- 15 Dec 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Charles 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.
PubMed 39823789
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
- ClinicalTrials.gov ID
- NCT01508416
- Acronym / sponsor ID
- METRO / 1108178
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Newly diagnosed, Thrombin generation, TFPI, Tissue Factor pathway inhibitor, Protein S, Thrombosis, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire, Groupe de Recherche sur la Thrombose
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Myeloma | – | –Patients with newly diagnosed Multiple Myeloma required chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed Multiple Myeloma required chemotherapy
Key inclusion criteria (3 listed)
- Inscription to medical assurance
- Patients who gave their written consent
- Patients with newly diagnosed Multiple Myeloma required chemotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change from baseline in Thrombin generation measure
Time frame: day 21
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Time frame: day 42
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Time frame: day 63
change from baseline in Thrombin generation measure
change from baseline in Thrombin generation measure
Time frame: day 0
change from baseline in Thrombin generation measure
9 secondary outcomes
image-confirmed venous thromboembolic events
Time frame: day 63
change from baseline in TFPI resistance measure
Time frame: day 21
change from baseline in acquired protein S deficiency measure
Time frame: day 21
change from baseline in TFPI resistance measure
Time frame: day 42
change from baseline in TFPI resistance measure
Time frame: day 63
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 63
change from baseline in TFPI resistance measure
Time frame: day 0
change from baseline in acquired protein S deficiency measure
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 39823789Charles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard TARDY, MD-PhD principal investigator
CHU de Saint-Etienne - CIC-EC (CIE3)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in Thrombin generation measure (time frame: day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.