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Study on Apixaban for Blood Clot Prevention in New Multiple Myeloma Patients and Those Having Knee Replacement Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Apixaban in two groups of patients. The first group includes patients with multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. These patients are newly diagnosed and have not yet received chemotherapy. The second group consists of patients who are undergoing surgery for a total knee replacement. The purpose of the study is to compare how Apixaban affects the generation of thrombin, a protein involved in blood clotting, in these two different groups.

Participants in the study will receive a 2.5 mg dose of Apixaban, which is a film-coated tablet taken orally. The study will monitor the levels of thrombin in the blood at specific times after taking the medication. This will help researchers understand how Apixaban works in preventing blood clots in patients with multiple myeloma and those undergoing knee replacement surgery. The study will also measure the concentration of Apixaban in the blood over a 12-hour period to observe how the body processes the medication.

The trial will continue for a period of time to gather enough data to make meaningful comparisons between the two groups. By studying the effects of Apixaban in these patients, researchers hope to improve the understanding of its role in preventing blood clots, which can be a serious complication in both multiple myeloma and after knee surgery. The findings from this study may help in optimizing treatment strategies for these conditions in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, consent, and medical condition. Participants must be over 18 years old and have signed informed consent.

    Participants are divided into two groups: those with de novo multiple myeloma and those undergoing total knee replacement surgery.

  2. Step 2

    Medication administration

    Participants receive a medication called Apixaban, which is a film-coated tablet taken orally.

    The dosage is 2.5 mg, and it is administered to prevent blood clots.

  3. Step 3

    Blood sample collection

    A blood sample is collected 2 hours after taking the first dose of Apixaban to measure the effect on blood clotting.

    This measurement is known as the endogenous thrombin potential (ETP), which helps understand how the medication affects blood clotting.

  4. Step 4

    Monitoring and additional measurements

    The concentration of Apixaban in the blood is measured over a 12-hour period after administration.

    Additional blood samples are taken at different times (0, 2, 6, and 12 hours) to evaluate how the medication affects blood clotting over time.

  5. Step 5

    Evaluation of treatment effects

    For participants with multiple myeloma, changes in the medication's effects are evaluated after several cycles of chemotherapy.

    The study aims to model the relationship between the medication's concentration in the blood and its effect on blood clotting.

  6. Step 6

    Completion of the study

    The study is expected to conclude by March 31, 2027.

    Participants' data will contribute to understanding the effects of Apixaban in preventing blood clots in different medical conditions.

Who can join the trial?

5 criteria

  • Patient over 18 years of age.
  • Signed informed consent. This means the patient agrees to participate in the study after being informed about it.
  • Patient covered by a social security scheme. This means the patient has health insurance or a similar coverage.
  • Group 1 (MM): Patient suffering from de novo multiple myeloma. This means the patient has a type of blood cancer and has not yet received chemotherapy. The treatment plan should include thromboprophylaxis with apixaban, which is a medication to prevent blood clots.
  • Group 2 (PTG): Patient undergoing knee joint replacement with a total prosthesis. This means the patient is having surgery to replace the knee joint. The treatment plan should include thromboprophylaxis with apixaban, which is a medication to prevent blood clots.

Who cannot join the trial?

4 criteria

  • Patients who are not receiving treatment for **newly diagnosed multiple myeloma**. This means patients who have already started chemotherapy for this condition cannot participate.
  • Patients who have not undergone surgery for **PTG**. PTG refers to a specific type of surgery, and only those who have had this surgery are eligible.
  • Patients who are not within the specified age range. The study is open to certain age groups, and those outside this range cannot join.
  • Patients who are part of a **vulnerable population**. This means individuals who might need special protection or care, such as those with certain disabilities or conditions, are not eligible.
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Investigated drugs

Apixaban is a medication used in this study to prevent blood clots. It works by inhibiting a substance in the blood called thrombin, which is involved in the formation of clots. In this trial, Apixaban is being tested to see how well it can reduce thrombin generation in patients with newly diagnosed multiple myeloma and those undergoing knee replacement surgery. The goal is to understand its effects on blood clot prevention in these specific groups of patients.

What is already known about the treatment

Apixaban – Apixaban is administered orally in tablet form. It is currently being studied for its effects on thrombin generation in patients with multiple myeloma and those undergoing knee replacement surgery. The main therapeutic use of Apixaban is to prevent blood clots, known as thromboembolism. It works by inhibiting a specific factor in the blood clotting process, reducing the ability of blood to form clots. Apixaban is classified as an anticoagulant, specifically a direct factor Xa inhibitor.

Investigated diseases

Thromboembolism Prophylaxis – This condition involves measures taken to prevent the formation of blood clots that can travel through the bloodstream and cause blockages in blood vessels. It is often a concern in patients who are at risk due to surgery, prolonged immobility, or certain medical conditions. The progression of thromboembolism can lead to complications such as deep vein thrombosis or pulmonary embolism if not properly managed. Preventive strategies may include medications, lifestyle changes, or mechanical devices to reduce the risk of clot formation. The focus is on maintaining normal blood flow and preventing clot-related complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515329-27-00Protocol code23CH293Estimated enrolment32 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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