[peterb72Participant]

Hello. I am 45 years old and was diagnosed with smouldering myeloma in May 2017. Since then have had blood tests every 3 months which so far have been stable, so no treatment yet.

My consultant has asked me to consider going on a new trial for smouldering myeloma patients to see if it has any benefit delaying progression to active myeloma. This would mean treatment with the antibody Daramutumab as an injection once a week (no other drugs).

This sounds promising but it is a difficult decision as nobody currently has the answers as to whether it would be of benefit, hence the trial. I am aware that Daramutumab has had promising results elsewhere, but is not available on the NHS for any standard treatments.

Has anybody else had any discussions/treatment with Daramutumab or have any general advice they can offer?

Many thanks, Peter.

 

[janebParticipant]

<span style=”color: #000000; font-family: UICTFontTextStyleBody; font-size: 17px; -webkit-text-size-adjust: auto;”>Hi peter. </span>
<div style=”color: #000000; font-family: UICTFontTextStyleBody; font-size: 17px; -webkit-text-size-adjust: auto;”>My husband didn’t get accepted for the trial at Nottingham as the trial had closed. He had repeated bloods and repeat bmb and his para protein levels dropped. He had a FISH but couldn’t do his  cytogenic profile as only 15% cancer in his bone marrow. He was therefore considered low risk and continues on 8 week monitoring.</div>
<div style=”color: #000000; font-family: UICTFontTextStyleBody; font-size: 17px; -webkit-text-size-adjust: auto;”>I would be interested to know if there are clinical trials running in the uk and their criteria ( my understanding is that there are no trials in the uk currently for daratumumab and smm) My understanding was also that you needed to have a pp level of 30+ to be accepted.</div>
<div style=”color: #000000; font-family: UICTFontTextStyleBody; font-size: 17px; -webkit-text-size-adjust: auto;”>Jane</div>

[peterb72Participant]

Hi Jane

Many thanks for your reply. I’m pleased to hear that your husband is considered low risk and is still smouldering.

Once I get some more details about any potential trial then I’ll let you know – at the moment I don’t have any details as it’s only something that has been mentioned to me as a possibility. My PP level is currently 30 so maybe that is why it has been mentioned – what is your husband’s PP level?

Thanks again & I’ll keep you posted once I hear any more.

Peter

[janebParticipant]

Hi Peter

it did go up to 30 but doesn’t remain stable and went down to mid 20’s. It has been creeping up again slowly. Next results due 1.2.18.

I would be very interested if you hear of any trials

Jane

[cygnetParticipant]

Hi Peter

What did you decide to do regarding the daratumumab trial please?

It was mentioned to me today at clinic so I am curious to know what you decided to do….

Many thanks,

Cygnet

 

 

[peterb72Participant]

Hi Cygnet

Which hospital are you at?

I’m still waiting on further details (still waiting to see consultant) so I don’t know yet about whether I’ll be eligible to be considered for the trial.

Are you going on the trial/has your consultant suggested you do so? It’s probably a difficult decision…have you smouldered for long or is it quite new? What age bracket are you in? I’m in my 40s and was diagnosed last year….the trial sounds promising but of course nobody knows the answers!

Best wishes

Peter

[cygnetParticipant]

Hi – I’m in Kent , and I understand there is a trial at the Kent and Canterbury.

It was mentioned to me by the Nurse Specialist – maybe because I asked alot of questions!!! I am a 56 year old female who was diagnosed three years ago. My pp at diagnosis was 25 but  on monitoring subsequently has ranged from 21 to now 26 (sigh). My bmb was 10% so I scraped into the smoldering category.

To be honest to hear a trial mentioned was a bit of a shock – I try to keep this in it’s box and I always thought I would just carry on as I have been until I needed to consider treatment. I was previously  told by the haematologist that bearing in mind my age and numbers I  would need a SCT at some point but he is very old school and not a myeloma specialist. Personally -assuming no other symptoms or issues – I judged I wouldn’t need to consider treatment options  until  if or when my pp hit 30.

I am self employed and have alot going on in my life so committing to a trial at this stage( even if I was eligible) seems a big step and I think I will stay as I am on active monitoring unless there are changes which make me reconsider. I just wondered where you were with it…..?

Best wishes,

C

 

 

 

[peterb72Participant]

Hi…like you I’m unsure about any trial as I’m not sure about having treatment when I don’t necessarily need it. It will be a difficult decision once I have to make it.

I’ll keep you posted with any developments….likewise please keep me posted about what you decide.

Thanks!

[janebParticipant]

Hi Peter

I wondered if you had made a decision about the Daratumumab trial? It was mentioned at my Husbands review today. PP up to 29.7 so May just meet the eligibility criteria.

Can I ask what your PP levels are.

I think we will go for it if eligible as PP levels have steadily creeped up over the last 2 and a half years  since diagnosis. He is 47.

Appreciate any info anyone has about the trial.

Thanks

jane

[peterb72Participant]

Hi Jane

Since last posting I have been through the trial ‘screening’ but was then deemed not eligible as my PP level was 25 (this despite my previous readings during normal monitoring being 30). So it was a surprise to hear that the screening test showed a lower level. Which is positive news I guess, but disappointing in terms of the trial as it meant I didn’t meet the criteria. However, my consultant has said I will continue to be monitored and if my levels have increased again later in the year then they may try to put me through the screening again – but who knows. So I’m a bit in limbo really. I think you are right to go for it for your husband – the screening is quite intensive for a couple of weeks (MRI, CT scan, blood/urine tests, bone marrow biopsy etc) but worth it if you get on the trial.

Let me know how you get on.

Thanks

Peter

 

[janebParticipant]

Hi Peter

thats a shame to go through the  screening process and not get accepted onto the trial. It sounds like your PP levels are not static like my husbands.

I assume the criteria is to have a PP level of 30 or more?

We are very interested in the trial and like yourself, we hope to be considered if and when my husbands PP levels rise above 30.

My concern is that the drug is only on offer for 3 years which is the length of the trial. Was there any discussion during the  screening about what happens after the 3 years assuming you’ve had and may continue to be having a good response? This is my primary concern, I’m worried that coming off the drug would result in the Myeloma becoming active and then having to start chemo. Would it be realistic to hope that after 3 years on Daratumumab the Myeloma could remain in remission for a period?

Also, was there any indication as to how many people they were accepting onto the trial and the closure date?

Thanks for the update Peter, I hope your pp levels continue to remain stable.

Jane

[peterb72Participant]

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

[janebParticipant]

Thank you Peter for your inciteful response which confirms our understanding of the trial.

We see the consultant in June for the 8 week bloods to see how PPs are doing and will discuss the trial with her as it hasn’t been discussed previously.

Interesting that you were advised that the trial closes at the end of the year. Whilst we all hope that those that smoulder do so for as long as possible, you almost wish that if thingcare going to progress then it will do so by the end of the year to benefit from the trial.

The uncertainty at this stage I think is what is so difficult to cope with.

It would be nice to keep in touch with regards to the trial Peter

Thanks again.

Jane

[peterb72Participant]

Hi Jane

I know exactly what you mean….when I was told I was not eligible for the trial because my screening results were better than expected and I was therefore not ‘high risk enough’, part of me was pleased (of course), but another part of me was disappointed as I knew this trial represents an opportunity to get a drug that could make a difference. Knowing it is not an open-ended trial makes this even more uncertain, i.e. there is a real danger that I (and others) can ‘miss the boat’ as the trial will of course close at some point. So I know exactly what you mean about the uncertainty.

The trial won’t definitely close at the end of the year – there is no fixed date – it will depend how quickly it fills up. My consultant just thought – based on an educated guess I imagine – that it would close at around the end of the year. Of course it could be sooner (unlikely) or later (likely) than that.

Yes, would definitely be good to keep in touch with the trial. I’ll keep you posted with any developments (I next see my consultant in June too), so please do keep me posted with any news too.

Thanks & best wishes

Peter

 

[bren123Participant]

I have been diagnosed with smouldering myeloma in august2018.
I have completed all the tests for this trial at Kent and Canterbury hospital
I was randomised by a computer to have watch and wait.
I will be closely monitored and have more tests so if anything happens, I will start treatment for myeloma.
It was a huge shock for me and my family, as it was found by routine blood tests.
Did everyone think they will die within a short time?
I am a very positive person and try to see the funny side of life(black humour).
Thank God for my family, friends and work.

[Author]

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