Clinical trial NCT02749617: A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
Official title: A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anti-Xa Activity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Anti Xa Activity
timeFrame: 3 months
Secondary outcomes:
measure: Plasma Apixaban Levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia, Division of Hematology
name: Agnes YY Lee, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: