Clinical trial · Interventional
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was stopped due to lack of enrollment.
Summary
Brief summary (as posted)
This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a prospective, cohort study of 24 participants with multiple myeloma, in whom a lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible participants will initiate thromboprophylaxis with apixaban prior to starting their DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and plasma drug concentration will be measured. This pilot study looks to investigate this potential interaction between apixaban and dexamethasone to see if it warrants further investigation in a larger study. The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month treatment period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-Xa Activity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apixaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apixaban
- description
- apixaban 2.5 mg PO BID
- interventionNames
- Drug: apixaban
Primary outcomes (1)
- measure
- Anti Xa Activity
- timeFrame
- 3 months
- description
- serial anti Xa activity
Secondary outcomes (1)
- measure
- Plasma Apixaban Levels
- timeFrame
- 3 months
- description
- Due to lack of enrollment, plasma apixaban levels were not analyzed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of multiple myeloma according to criteria of the International Myeloma Working Group * Patients in whom a LEN-DEX-based treatment regimen is indicated * Adult patients ≥ 19 years of age who are able to freely provide informed consent Exclusion Criteria: * Concomitant antiplatelet or anticoagulant use * Calculated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times upper limit of normal (ULN) * Total bilirubin \> 2 x ULN * Thrombocytopenia \< 50 x 10 gigalitres (Gl) * High bleeding risk or spontaneously prolonged prothrombin time or activated partial thromboplastin time \> 1.5 x ULN * Body weight \<50 or \>120 kg * Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors * Use of Ginkgo biloba or St. John's Wort within 14 days before first dose of study drug * Dexamethasone use within last 3 months * Women of Childbearing potential without proper contraceptive measures, pregnancy or breast feeding * Life expectancy less than 3 months * Inability to swallow or issues with malabsorption * Any other medical, social, logistical, geographical or psychological factors, which in the opinion of the investigator, would prohibit follow-up, compliance and study completion
References
Publications (0)
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