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

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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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

apixaban
Experimental group
Description:
apixaban 2.5 mg PO BID
Treatment:
Drug: apixaban

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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