A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Phase 2TerminatedNCT02749617

University of British Columbia2 enrolled

Overview

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.

Study has terminated due to poor enrollment.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Anti-Xa Activity

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Anti Xa Activity

serial anti Xa activity

Time frame: 3 months

Secondary Outcomes

Plasma Apixaban Levels

Due to lack of enrollment, plasma apixaban levels were not analyzed