Anti-Xa Activity
Conditions
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.
Interventions
DRUGapixaban
2.5 mg PO BID
Sponsors
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti Xa Activity | 3 months | serial anti Xa activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Apixaban Levels | 3 months | Due to lack of enrollment, plasma apixaban levels were not analyzed |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Apixaban apixaban 2.5 mg PO BID
apixaban: 2.5 mg PO BID | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Apixaban |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment Canada | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Anti Xa Activity
serial anti Xa activity
Time frame: 3 months
Population: Lack of data.
Secondary
Plasma Apixaban Levels
Due to lack of enrollment, plasma apixaban levels were not analyzed
Time frame: 3 months