A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

NCT02749617 | Terminated Phase 2 Results

• 1 other identifier: H14-01652
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti-Xa Activity

Outcome Measures

Primary Outcomes (1)

• Anti Xa Activity

  serial anti Xa activity

  3 months

Secondary Outcomes (1)

• Plasma Apixaban Levels

  3 months

Study Arms (1)

apixaban

EXPERIMENTAL

apixaban 2.5 mg PO BID

Drug: apixaban

Interventions

apixaban DRUG

2.5 mg PO BID

Also known as: Eliquis

apixaban

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Interventions

apixaban

Results Point of Contact

• Title: Director of HRP
• Organization: Hematology Research Program (HRP)

alee14@bccancer.bc.ca

6048754111

Study Officials

• Agnes YY Lee, MD MSc FRCPC

  University of British Columbia, Division of Hematology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 25, 2016
• Study Start: August 9, 2016
• Primary Completion: January 3, 2018
• Study Completion: March 28, 2019
• Last Updated: August 23, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-07

Locations

CA (1)