Anti-Xa ActivityPhase 2ADAMNCT02749617
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
A Phase 2 study testing apixaban in people with Anti-Xa Activity, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anti-Xa Activity
- What is being tested?
- apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2016to 28 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study has terminated due to poor enrollment.
- Conditions
- Anti-Xa Activity
- Being tested
- apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apixabanDrug
Also called Eliquis
2.5 mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| apixaban | Experimental | apixaban 2.5 mg PO BID Receives: Drug: apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Xa Activity
serial anti Xa activity
Measured: 3 months
Secondary outcomes (1)
Plasma Apixaban Levels
Due to lack of enrollment, plasma apixaban levels were not analyzed
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start9 Aug 2016
- Primary completion3 Jan 2018
- Study completion28 Mar 2019
Why it stopped: Study was stopped due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anti-Xa ActivityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Lee, University of British Columbia
- Investigators
- Agnes YY Lee, MD MSc FRCPC, Principal investigator, University of British Columbia, Division of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749617
- Sponsor's protocol ID
- H14-01652
- Acronym
- ADAM
- Status last verified
- Jul 2021
- First submitted
- 30 Mar 2016
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02749617
- Acronym / sponsor ID
- ADAM / H14-01652
- Conditions
- Anti-Xa Activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to lack of enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apixaban | Experimental | Drug: apixabanapixaban 2.5 mg PO BID |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apixabanAlso: Eliquis2.5 mg PO BID | Drug | apixaban |
Primary outcome
Anti Xa Activity
Time frame: 3 months
serial anti Xa activity
1 secondary outcome
Plasma Apixaban Levels
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENT
Thromboembolic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YY Lee, MD MSc FRCPC principal investigator
University of British Columbia, Division of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apixaban in people with Anti-Xa Activity, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Xa Activity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.