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

NCT06474182 | Recruiting

• 2 other identifiers: 23CH293ANSM
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Multiple myeloma; thromboprophylaxis; pharmacodynamics; coagulability

Outcome Measures

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

  2 hours after Apixaban Treatment

Secondary Outcomes (5)

• Apixaban concentration (ng/mL)

  Kinetics of 12 hours following Apixaban treatment in both groups

• Pharmacodynamics' kinetics of Endogenous Thrombin Potential

  Kinetics of 12 hours following Apixaban treatment in both groups

• Pharmacodynamics' kinetics of Lagtime

  Kinetics of 12 hours following Apixaban treatment in both groups

• Pharmacodynamics' kinetics of Time to peak

  Kinetics of 12 hours following Apixaban treatment in both groups

• Pharmacodynamics' kinetics of Thrombin peak

  Kinetics of 12 hours following Apixaban treatment in both groups

Study Arms (2)

Blood sampling of patients with de novo multiple myeloma

EXPERIMENTAL

Description: Blood sampling of patients with de novo multiple myeloma

Procedure: Blood sampling; Drug: Apixaban

Blood sampling of patients undergoing total knee replacement

EXPERIMENTAL

Description: Blood sampling of patients undergoing total knee replacement

Procedure: Blood sampling; Drug: Apixaban

Interventions

Blood sampling PROCEDURE

Blood sampling

Blood sampling of patients undergoing total knee replacement; Blood sampling of patients with de novo multiple myeloma

Apixaban DRUG

Treatment by Apixaban

Blood sampling of patients undergoing total knee replacement; Blood sampling of patients with de novo multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Blood Specimen Collection; apixaban

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie CHALAYER, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CHALAYER, MD

CONTACT

(0)477822814; emilie.chalayer@chu-st-etienne.fr

Florence RANCON

CONTACT

(0)4 77 82 94 58; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: June 25, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FR (1)