Research Study

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
Principal Investigator 
Agnes Lee

Overview

Body Locations and Systems 
Blood
Disorders and Conditions 
Multiple Myeloma
ClinicalTrials.gov# 
NCT02749617
Status 
Recruiting
Study Start/End 
Jun 23, 2016 to May 7, 2018
Locations 
Vancouver General Hospital
Name/Title 
Mabel J.Y. Ma, Research Assistant
Phone 
604-537-1433
Email Address 
mabel.ma@alumni.ubc.ca
Purpose of Study 

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.

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.