Hi Jane
Yes a disappointment re the trial but we’ll see how it goes throughout this year. To answer your questions:
Yes I believe a PP level of 30 or more is needed to qualify. Also, as part of the screening, I believe they test your ‘light chains’ in your blood (this was not something that my normal monitoring had tested previously). My result was apparently a ‘normal ratio’ (positive news) but again to qualify for the trial you needed to have an ‘abnormal ratio’. In essence they are saying, based on the screening results, I am ‘not high-risk enough’ to qualify for the trial. This despite the fact that my consultant thought I was ‘high risk enough’ before she put me through the screening. But the hospital has no influence/control over the decision of the screening result (this I believe is done centrally in Switzerland). So whilst disappointing, there are positives in the sense that I am not as ‘high risk’ as thought. But I will continue to be monitored throughout this year and if my consultant thinks it is worth ‘another go’ at the screening later in the year then she will put me through it again.
I think (but not certain) that there are about 150 places available on this trial….whilst this doesn’t seem many, I believe they are not ‘recruiting’ as quickly as first thought as a lot of people (like me) are failing to get through the very strict screening criteria. My consultant thinks they will continue to recruit until the end of 2018.
As for the question of what happens – if you get on the trial and get the drug (rather than just being on the ‘control arm’) – at the end of 3 years, then I believe this will be the end of treatment so to speak and you will then be monitored. This is really a step into the unknown…they seem pretty confident that the drug will give a good response during the 3 years and keep the disease at bay, but it is far less known what happens when the trial stops – will you continue to benefit from the good effect of the 3 years, or will the disease come back more aggressively and be more difficult to treat? Nobody knows the answer to that, hence the trial, so it really is a step into the unknown.
I think if you knew (which none of us do) that the disease was going to become active in the next 3 years then the trial would be the way to go, as I think the drug will keep it at bay. But if you thought it wasn’t going to become active in the next 3 years then possibly the trial is not the way to go as it’s unknown what effect it will have longer term. Of course this drug is not licensed in the UK for this treatment stage, and even if the trial proves to be a success, then it’s going to be at least 5 – 10 years I guess before it becomes licensed as the trial outcomes will need to be reviewed for a period after the trial ends.
All of this is just me guessing really – it really is a difficult position to be in. After much deliberation with my wife I decided to go for the trial, but didn’t get on it. I guess you & your husband need to make a decision based on your gut feeling, as there is not much else to go on!
Let me know how you get on….
Thanks
Peter
