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

Primary Purpose

Anti-Xa Activity

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

apixaban

About this trial

This is an interventional prevention trial for Anti-Xa Activity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Vancouver General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

apixaban

Arm Description

apixaban 2.5 mg PO BID

Outcomes

Primary Outcome Measures

Anti Xa Activity

serial anti Xa activity

Secondary Outcome Measures

Plasma Apixaban Levels

Due to lack of enrollment, plasma apixaban levels were not analyzed

Full Information

NCT ID

NCT02749617

First Posted

March 30, 2016

Last Updated

July 28, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02749617

Brief Title

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Acronym

ADAM

Official Title

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Study was stopped due to lack of enrollment.

Study Start Date

August 9, 2016 (Actual)

Primary Completion Date

January 3, 2018 (Actual)

Study Completion Date

March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anti-Xa Activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

apixaban

Arm Type

Experimental

Arm Description

apixaban 2.5 mg PO BID

Intervention Type

Drug

Intervention Name(s)

apixaban

Other Intervention Name(s)

Eliquis

Intervention Description

2.5 mg PO BID

Primary Outcome Measure Information:

Title

Anti Xa Activity

Description

serial anti Xa activity

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Plasma Apixaban Levels

Description

Due to lack of enrollment, plasma apixaban levels were not analyzed

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agnes YY Lee, MD MSc FRCPC

Organizational Affiliation

University of British Columbia, Division of Hematology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

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