Trial? Trial?

Na het vorige bezoek heb ik me verdiept in de trial voor het nieuwe medicijn waar ik mogelijk aan mee kan gaan doen. Gelukkig is alles openbaar en op internet te vinden. Ook de inclusie en exclusie criteria die zijn bepaald door de farmaceut die het medicijn op de markt wil brengen. Daarin las ik dat er wereldwijd voor deze trial maar 270 patiënten worden gezocht. Dat is wel heel erg weinig, en op mijn aandringen hebben we de intake-afspraak vervroegd.
Ben gewoon bang dat ik straks door de screening heen ben gekomen en dat men zegt “sorry, maar u bent nummer 271”.
Vandaag de intake gehad. Goede voorlichting en alle (inmiddels bij mij bekende criteria) worden doorgenomen. Zo moet het Hb onder de 6.2 zijn (was nu 5.7), de milt moet groot zijn en minimaal 5 cm onder de ribbenboog uit steken (voldoet), minimaal nog 6 maanden te leven hebben (gelukkig wel), en er moeten een aantal “secundaire” verschijnselen zijn zoals zware vermoeidheid, afvallen, verminderde eetlust en nog een aantal (heb ik ook).
Volgens de hematoloog voldoe ik zo op het eerste gezicht aan alle criteria die door de farmaceut gesteld zijn en we kunnen verder. Ter plekke onderteken ik een verklaring dat ik mee wil werken aan de trial en de bijbehorende onderzoeken. Een uitgebreid schema maakt onderdeel uit van de documentatie. De eerste vier weken na goedkeuring door de farmaceut iedere week een bezoek aan het ziekenhuis. Totaal in 36 weken 4 maal een MRI, 14 maal bloedonderzoek, 2 maal beenmergpunctie, 4 maal ECG. Ze houden je wel in de gaten met het testen van nieuwe medicijnen 😉
Als eerste moeten er nu metingen gedaan worden om definitief goedkeuring te krijgen van de farmaceut dat ik mee mag doen.  De verschillende onderzoeken, waaronder een beenmergbiopt, worden nu ingepland. Het ECG (hartfilmpje) hebben we gelijk al laten maken.

De trial bestaat overigens uit een vergelijkende test. Door loting bepaalt men of je het medicijn mag uitproberen (2 van de 3 patiënten) of dat je in de groep valt die “de beste, beschikbare behandeling” krijgt (1 van de 3 patiënten dus zonder het nieuwe medicijn). Hopen dus dat ik mee mag doen met het nieuwe medicijn.

Ben blij dat er nu iets in gang wordt gezet. Er moet ook iets gebeuren want ik ga wel hard achteruit. Naast mijn vaste ochtendritme waarin ik energie spaar door vrijwel niets anders te doen dan TV kijken en krant lezen, moet ik nu ook aan het einde van de middag rusten om de dag verder door te komen. Vermoeidheid is een van de grootste problemen die ik heb. Hier kampen overigens alle Myelofibrose patiënten mee. De medicijnen zouden hierbij verbetering moeten geven. Laten we het hopen!

Bij deze controle is het Hb (energie) weer gezakt van 6.1 naar 5.7, maar zijn de plaatjes iets gestegen naar 98. De witte (weerstand) doen het nog steeds goed 7.3.

Binnenkort het vervolg van alle onderzoeken die nodig zijn om te bepalen of ik mee mag doen met de trial.

Toevallig precies nu een leuk boek aan het lezen. John Grisham “Claim”. Gaat over mega claims die advocaten bij farmaceuten neerleggen (uiteraard in Amerika) voor het op de markt brengen van medicijnen die niet deugen……

332 gedachten over “Trial? Trial?

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