A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Anti-Xa Activity Clinical Trial

— ADAM  

Official title:

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02749617
• Other study ID #: H14-01652
• Status: Terminated
• Phase: Phase 2
• Start date: August 9, 2016
• Est. completion date: March 28, 2019

Study information

• Verified date: July 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study has terminated due to poor enrollment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 28, 2019
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anti-Xa Activity
• Multiple Myeloma

Intervention

Drug:
• apixaban
2.5 mg PO BID

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti Xa Activity	serial anti Xa activity	3 months
Secondary	Plasma Apixaban Levels	Due to lack of enrollment, plasma apixaban levels were not analyzed	3 months