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

July 28, 2021 updated by: Agnes Lee, University of British Columbia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study has terminated due to poor enrollment.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apixaban
apixaban 2.5 mg PO BID
Drug: apixaban
2.5 mg PO BID
Other Names:
  • Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti Xa Activity
Time Frame: 3 months
serial anti Xa activity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Apixaban Levels
Time Frame: 3 months
Due to lack of enrollment, plasma apixaban levels were not analyzed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Agnes YY Lee, MD MSc FRCPC, University of British Columbia, Division of Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2016

Primary Completion (Actual)

January 3, 2018

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-01652

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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