A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma (ADAM)

University of British Columbia

Status and phase

Terminated

Phase 2

Conditions

Anti-Xa Activity

Treatments

Drug: apixaban

Study type

Interventional

Funder types

Other

Identifiers

NCT02749617

H14-01652

Details and patient eligibility

About

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.

Full description

Study has terminated due to poor enrollment.

Enrollment

2 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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