A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

• Status: Terminated
• Trial end date: 2019-03-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Apixaban; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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