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

• Sponsor: University of British Columbia (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02749617
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 31.6
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anti-Xa Activity	Drug: apixaban	Phase 2

Detailed Description

Study has terminated due to poor enrollment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
• Actual Study Start Date: Aug 9, 2016
• Actual Primary Completion Date: Jan 3, 2018
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: apixaban apixaban 2.5 mg PO BID	Drug: apixaban; 2.5 mg PO BID; Other Names: Eliquis

Outcome Measures

Primary Outcome Measures

1. Anti Xa Activity [3 months]

   serial anti Xa activity

Secondary Outcome Measures

1. Plasma Apixaban Levels [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• University of British Columbia

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2017

More Information

Publications

None provided.

• Responsible Party: Agnes Lee, Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02749617
• Other Study ID Numbers: H14-01652
• First Posted: Apr 25, 2016
• Last Update Posted: Aug 23, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Multiple Myeloma; Apixaban

Study Results

Participant Flow

Arm/Group Title	Apixaban
Arm/Group Description	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Apixaban
Arm/Group Description	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	2 100%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 50%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Canada	2 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Lack of data.

Arm/Group Title	Apixaban
Arm/Group Description	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	Apixaban
Arm/Group Description	apixaban 2.5 mg PO BID apixaban: 2.5 mg PO BID
All Cause Mortality
	Apixaban
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Serious Adverse Events
	Apixaban
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Apixaban
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Blood and lymphatic system disorders
Nose Bleed	1/2 (50%)	3
General disorders
Nausea	1/2 (50%)	1
Flu-like Symptoms	1/2 (50%)	1
Diarrhea	1/2 (50%)	1
Pseudomonas aerugionosa	1/2 (50%)	1
Skin Itchiness	1/2 (50%)	3
Low Energy	1/2 (50%)	1
Back right-sided buttock pain	1/2 (50%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.