Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06474182

Comparison of the Effects of Prophylactic Apixaban on Thrombin Generation in Patients With New Multiple Myeloma and Those Undergoing Total Knee Replacement Surgery

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-09-25

32

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how Apixaban, a medication recommended to prevent blood clots, affects blood clotting in patients with newly diagnosed multiple myeloma (MM) compared to patients undergoing total knee replacement surgery who also receive blood clot prevention. This study aims to understand if differences in how the drug is processed in the body impact its ability to reduce blood clotting in these two groups. The findings may help improve blood clot prevention in MM patients. The study includes two groups: one with patients newly diagnosed with multiple myeloma who need Apixaban to prevent blood clots, and another with patients having surgery for total knee replacement who also require Apixaban. Blood samples will be taken from both groups to measure the medication's concentration and its effects on blood clotting over a 12-hour period after treatment. Participants will have blood samples collected to analyze how Apixaban influences thrombin generation, a key factor in blood clotting, measured 2 hours after treatment and monitored over 12 hours. The study will track Apixaban levels and several clotting parameters, including lag time, time to peak, and thrombin peak. This non-randomized, single-blind trial will last until September 2027, and participants' safety and clotting responses will be carefully observed throughout.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Signed informed consent
  • Covered by a social security scheme
  • Patients with a diagnosis of new multiple myeloma needing Apixaban for blood clot prevention
  • Patients scheduled for total knee replacement surgery needing Apixaban for blood clot prevention
Not Eligible

You will not qualify if you...

  • Receiving curative doses of anticoagulation treatment
  • Contraindication to Apixaban
  • Pregnant or breastfeeding women
  • Refusal to sign consent
  • Patients under legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 hours following Apixaban treatment

Participants receive treatment with Apixaban and undergo blood sampling to assess thrombin generation and Apixaban pharmacodynamics.

1 treatment period with blood sampling visits during 12 hours

Trial Site Locations

Total: 1 location

1

CHU de Saint-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

E

Emilie CHALAYER, MD

F

Florence RANCON

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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