A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
Status:
Terminated
Trial end date:
2019-03-28
Target enrollment:
Participant gender:
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.