A Pilot Study Investigating Apixaban and Dexamethasone In... | NCT02749617

Studies
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

NCT02749617

Sponsor

University of British Columbia

Status

Terminated

Last Update Posted

Aug 23, 2021Actual

Enrollment

2Actual

Phase

Phase 2

Conditions

Anti-Xa Activity

Interventions

apixaban

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to lack of enrollment.

Expanded Access Info

Start Date

Aug 9, 2016Actual

Primary Completion Date

Jan 3, 2018Actual

Completion Date

Mar 28, 2019Actual

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Apr 20, 2016

First Posted Date

Apr 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Jul 28, 2021

Results First Submitted that Met QC Criteria

Jul 28, 2021

Results First Posted Date

Aug 23, 2021Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Aug 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
apixaban	Experimental	apixaban 2.5 mg PO BID	Drug: apixaban

Name	Type	Description	Arm Group Labels	Other Names
apixaban	Drug	2.5 mg PO BID	apixaban	Eliquis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Agnes YY Lee, MD MSc FRCPC	University of British Columbia, Division of Hematology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital		Vancouver	British Columbia	V5Z 1M9	Canada

ID	Title	Description
FG000	Apixaban	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Apixaban	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Anti Xa Activity

serial anti Xa activity

Lack of data.

Posted

3 months

ID	Title	Description
OG000	Apixaban	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

6 months

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Apixaban	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID	2

Serious Adverse Events

Not provided

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nose Bleed	Blood and lymphatic system disorders		Systematic Assessment