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Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

ConditionsMultiple MyelomaTotal Knee Replacement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Curative doses of anticoagulation treatment,

Contra-indication to Apixaban,

Pregnant or breastfeeding woman,

Refusal to sign consent,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Procedure/Surgery

    Blood sampling

  • Apixaban

    Drug

    Treatment by Apixaban

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Blood sampling of patients with de novo multiple myelomaExperimental treatment 2 interventions
Group B: Blood sampling of patients undergoing total knee replacementExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 hours after Apixaban Treatment

Secondary outcomes

1

Apixaban concentration (ng/mL)

Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups

Time frame
Kinetics of 12 hours following Apixaban treatment in both groups
2

Pharmacodynamics' kinetics of Endogenous Thrombin Potential

MidiCAT method measure : Endogenous Thrombin Potential (nM.min)

Time frame
Kinetics of 12 hours following Apixaban treatment in both groups
3

Pharmacodynamics' kinetics of Lagtime

MidiCAT method measure : Lagtime (min)

Time frame
Kinetics of 12 hours following Apixaban treatment in both groups
4

Pharmacodynamics' kinetics of Time to peak

MidiCAT method measure : Time to peak (min)

Time frame
Kinetics of 12 hours following Apixaban treatment in both groups

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Source ClinicalTrials.gov
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