A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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Study has terminated due to poor enrollment.

Official Title
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A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Conditions
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Anti-Xa Activity

Intervention / Treatment
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* Drug: apixaban


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apixaban<br>apixaban 2.5 mg PO BID | Drug: apixaban<br>* 2.5 mg PO BID<br>* Other names: Eliquis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti Xa Activity | serial anti Xa activity | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Apixaban Levels | Due to lack of enrollment, plasma apixaban levels were not analyzed | 3 months |