Clinical Trial Results:
Evaluation of the use of an oral direct anti-Xa anticoagulant, Apixaban in prevention of venous thromboembolic disease in patients treated with IMiDs during myeloma: a pilot study
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Summary
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EudraCT number |
2013-003190-99 |
Trial protocol |
FR |
Global end of trial date |
08 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Jun 2022
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First version publication date |
18 Jun 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
38RC13.410
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02066454 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
CHU de GRENOBLE
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Sponsor organisation address |
CS 2017, GRENOBLE, France,
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Public contact |
Directrice générale du CHU de GRENOBLE, CHU de Grenoble, 33 0476768455, ARCPromoteur@chu-grenoble.fr
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Scientific contact |
Directeur général du CHU de GRENOBLE, CHU de Grenoble, 33 0476768455, ARCPromoteur@chu-grenoble.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jun 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Aug 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate:
- the incidence of venous thromboembolic event (VTE)
- the incidence of hemorrhagic complications,
In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day
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Protection of trial subjects |
An independent oversight committee will be established.
It will be led by 4 people: 2 vascular doctors, 1 hematologist and 1 pharmacovigilant.
Its role is to:
• Monitor the frequency of events (critical events and ISGs).
• Give an opinion on the continuation or not of the trial (premature termination, continuation of inclusions, request for an interim analysis) based on the data provided by the biostatistician of the CIC of Grenoble
This committee will meet in the following cases:
- occurrence of 5 events validated by the validation committee of the type thromboembolic event, arterial event, hemorrhage or death
- occurrence of an unexpected serious adverse reaction or SUSAR
- occurrence of an adverse reaction with an unusual frequency
-all 50 patients included
It may also be convened at the initiative of the promoter and the event validation committee. It shall keep the sponsor and the Scientific Committee informed of its conclusions in writing.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 108
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Worldwide total number of subjects |
108
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EEA total number of subjects |
108
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
107
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
105 patients, from the centres of the Intergroupe Francophone du Myélome (IFM), | ||||||||||||
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Pre-assignment
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Screening details |
After determining the type of myeloma treatment and deciding to initiate thromboprophylaxis, the inclusion and non-inclusion criteria of the study having been verified, the biological and ultrasound data of the screening collected, patients are then eligible for the study treatment, Apixaban | ||||||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
non applicable
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Arms
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Arm title
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one arm | ||||||||||||
Arm description |
Apixaban, 2.5 mgx2 / day, for 6 months | ||||||||||||
Arm type |
1 arm | ||||||||||||
Investigational medicinal product name |
Apixaban
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Buccal tablet
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Routes of administration |
Buccal use
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Dosage and administration details |
Apixaban, 2.5 mgx2 / day, for 6 months
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
one arm
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Reporting group description |
Apixaban, 2.5 mgx2 / day, for 6 months | ||
Subject analysis set title |
One Arm
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
evaluate the incidence of venous thromboembolic event and the incidence of hemorrhagic complications
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End point title |
evaluate the incidence of venous thromboembolic event and the incidence of hemorrhagic complications | ||||||||||||
End point description |
Total venous thromboembolism (fatal or nonfatal PE, symptomatic distal or proximal DVT of lower limbs, asymptomatic proximal DVT detected by bilateral
compression ultrasound and VTE-related death) and major or clinically relevant nonmajor bleeding
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End point type |
Primary
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End point timeframe |
All patients received apixaban, 2.5 mg x 2/day for 6 months, and were monitored monthly for 7 months (clinical parameters—pulse, blood pressure, biochemistry—blood count, renal function, hepatic parameters).
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Statistical analysis title |
Primary endpoint | ||||||||||||
Comparison groups |
one arm v One Arm
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Number of subjects included in analysis |
208
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0 | ||||||||||||
Method |
incidence of VTE | ||||||||||||
Parameter type |
clinical outcomes during treatment | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
At each visit until end of study
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
intervention
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Reporting group description |
Apixaban, 2.5 mgx2 / day, for 6 months | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Mar 2014 |
Addition of 1 center: Daniel HOLLARD Institute and 1 investigator |
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20 Mar 2014 |
Addition of a center: Centre Hospitalier d'Avignon
Principal Investigator :D r SLAMA Borhane
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14 Oct 2014 |
Change of principal investigator of the Centre Hospitalier La Côte Basque:
Principal Investigator: Dr RANDRIAMALALA Edouard |
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15 Oct 2014 |
Addition of 2 centers: RENNES and AMIENS
Update:
- the diagram of the study,
- the Ecog inclusion criterion >2,
- precision on the 1st EchoDopler made between D-7 and J-1
- the date of the meeting of the Supervisory Committee,
- contact details of vigilance/Promoter,
- the definition of the events seen by the event validation committee
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03 Dec 2014 |
Addition of a centre and a principal investigator for the Beausoleil Clinic centre
Associate Investigator: Dr Sophie AUGER QUITTET
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12 Jan 2015 |
Addition of a centre and a principal investigator for the Blois hospital centre
Associate Investigator: Dr Abderrazak EL YAMANI
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09 Jun 2015 |
Addition of 4 centers:
Lucien Neuwirth Cancer Institute// Principal Investigator :D r Augeul-Meunier
Chartres Hospitals// Principal Investigator: Dr MAIGRE
Hôpital sévigné Cesson RENNES// Principal investigator: Dr BAREAU
CH MACON// Principal Investigator: Dr RAICHON
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20 Jul 2015 |
Addition of 2 centers:
University Cancer Institute TOULOUSE// Principal Investigator :P r ATTAL
CHU ESTAING CLERMONT FERRAND// Principal Investigator: DR CHALETEIX
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
