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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma Total Knee Replacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Blood sampling of patients with de novo multiple myeloma

Description: Blood sampling of patients with de novo multiple myeloma

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Blood sampling

Apixaban

Intervention Type DRUG

Treatment by Apixaban

Blood sampling of patients undergoing total knee replacement

Description: Blood sampling of patients undergoing total knee replacement

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Blood sampling

Apixaban

Intervention Type DRUG

Treatment by Apixaban

Interventions

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Blood sampling

Intervention Type PROCEDURE

Apixaban

Treatment by Apixaban

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Curative doses of anticoagulation treatment,
* Contra-indication to Apixaban,
* Pregnant or breastfeeding woman,
* Refusal to sign consent,
* Patient under legal protection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No