A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Phase 2

Terminated

• Conditions: Anti-Xa Activity
• Interventions: Drug: apixaban

• Registration Number: NCT02749617
• Lead Sponsor: University of British Columbia

Brief Summary

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

Study has terminated due to poor enrollment.

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-08-09
• Primary Completion: 2018-01-03
• Study Completion: 2019-03-28
• Status Verified: 2021-07
• Results First Submitted: 2021-07-28
• Results First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Results First Posted: 2021-08-23
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apixaban	apixaban	apixaban 2.5 mg PO BID

Primary Outcome Measures

Name	Time	Method
Anti Xa Activity	3 months	serial anti Xa activity

Secondary Outcome Measures

Name	Time	Method
Plasma Apixaban Levels	3 months	Due to lack of enrollment, plasma apixaban levels were not analyzed

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada