TriangleNCT02749617 · REGISTRY CONDITION SEARCH
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2021-08-23
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 19 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- apixaban 2.5 mg PO BID
- intervention Names
- Drug: apixaban
- label
- apixaban
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- apixaban
- description
- 2.5 mg PO BID
- name
- apixaban
- other Names
- Eliquis
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- PREVENTION
Enrollment
- count
- 2
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- serial anti Xa activity
- measure
- Anti Xa Activity
- time Frame
- 3 months
- secondary Outcomes
- description
- Due to lack of enrollment, plasma apixaban levels were not analyzed
- measure
- Plasma Apixaban Levels
- time Frame
- 3 months
Full 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.
- detailed Description
- Study has terminated due to poor enrollment.
Source references
Source notices and limitations
Discovery and provenance
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- source file
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Preserved source evidence · Not medical advice