Multiple MyelomaProApixNCT06474182
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
A study testing Blood sampling and Apixaban in people with Multiple Myeloma and Total Knee Replacement, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Total Knee Replacement
- What is being tested?
- Blood sampling and Apixaban
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2025to Mar 2028
- Phase
- Interventional
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
Who may be able to join
- Age ≥ 18 years old,
- Signed informed consent,
- Patient covered by a social security scheme.
- Group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with Apixaban,
- Group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with Apixaban.
Who cannot join
- Curative doses of anticoagulation treatment,
- Contra-indication to Apixaban,
- Pregnant or breastfeeding woman,
- Refusal to sign consent,
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Emilie CHALAYER, MD, (0)4 77 82 28 14 ext. 33, emilie.chalayer@chu-st-etienne.fr
Jean-Yves BIEN, MD
About this study
Official title: Comparison of the Effects of Prophylactic Administration of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma and Patients Undergoing a Surgery for Total Knee Replacement
Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.
- Conditions
- Multiple Myeloma, Total Knee Replacement
- Being tested
- Blood sampling, Apixaban
- Keywords
- Multiple myeloma, thromboprophylaxis, pharmacodynamics, coagulability
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling
ApixabanDrug
Treatment by Apixaban
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling of patients with de novo multiple myeloma | Experimental | Description: Blood sampling of patients with de novo multiple myeloma Receives: Procedure: Blood sampling; Drug: Apixaban |
| Blood sampling of patients undergoing total knee replacement | Experimental | Description: Blood sampling of patients undergoing total knee replacement Receives: Procedure: Blood sampling; Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Thrombin potential (nM.min)
Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment
Measured: 2 hours after Apixaban Treatment
Secondary outcomes (5)
Apixaban concentration (ng/mL)
Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups
Measured: Kinetics of 12 hours following Apixaban treatment in both groups
Pharmacodynamics' kinetics of Endogenous Thrombin Potential
MidiCAT method measure : Endogenous Thrombin Potential (nM.min)
Measured: Kinetics of 12 hours following Apixaban treatment in both groups
Pharmacodynamics' kinetics of Lagtime
MidiCAT method measure : Lagtime (min)
Measured: Kinetics of 12 hours following Apixaban treatment in both groups
Pharmacodynamics' kinetics of Time to peak
MidiCAT method measure : Time to peak (min)
Measured: Kinetics of 12 hours following Apixaban treatment in both groups
Pharmacodynamics' kinetics of Thrombin peak
MidiCAT method measure : Thrombin peak (M, Thrombin)
Measured: Kinetics of 12 hours following Apixaban treatment in both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start15 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CHALAYER, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474182
- Sponsor's protocol ID
- 23CH293
- Other IDs
- 2024-515329-27-00
- Acronym
- ProApix
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No