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

Study acronym: ProApix
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 2027 → Sep 2027
See other at-risk trials from Centre Hospitalier Universitaire de Saint Etienne

Record History

  1. Primary completion pushed from Mar 2027 to Sep 2027 Enrollment increased: 32 → 36 participants · Completion pushed from Sep 2027 to Mar 2028 · Eligibility criteria expanded, about 10 words · 1 more Show 4 more changesShow less
    • Enrollment increased: 32 → 36 participants
    • Completion pushed from Sep 2027 to Mar 2028
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 5 entries
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 2025 to Sep 15, 2025 · Site details revisedv12 Show 2 more changesShow less
    • Start date changed from estimate of Jul 2025 to Sep 15, 2025
    • Site details revised
  3. Start date: Jun 2025 to Jul 2025v11
  4. Start date: May 2025 to Jun 2025v10
  5. Primary completion date: May 30, 2026 to Mar 2027 Completion date: Dec 31, 2026 to Sep 2027 · Start date: Apr 2025 to May 2025v9 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Sep 2027
    • Start date: Apr 2025 to May 2025
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Mar 2025 to Apr 2025v8
  2. Start date: Feb 2025 to Mar 2025v7
  3. Start date: Dec 2024 to Feb 2025v6
  4. Start date: Nov 2024 to Dec 2024v5
  5. Start date: Oct 2024 to Nov 2024v4
  6. Start date: Sep 2024 to Oct 2024v3
  7. Start date: Jun 2024 to Sep 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06474182
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Conditions Multiple Myeloma, Total Knee Replacement
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov