A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

NCT ID: NCT02749617

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-09
• Study Completion Date: 2019-03-28

Brief 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.

Detailed Description

Study has terminated due to poor enrollment.

Conditions

Anti-Xa Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

apixaban

apixaban 2.5 mg PO BID

Group Type: EXPERIMENTAL

apixaban

Intervention Type: DRUG

2.5 mg PO BID

Interventions

apixaban

2.5 mg PO BID

Intervention Type: DRUG

Other Intervention Names

Eliquis

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Agnes Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnes YY Lee, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Division of Hematology

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H14-01652

Identifier Type: -

Identifier Source: org_study_id