Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital

Utsikt said:
I would be extremely surprised if it is recruitment. The interest is massive, and Fluge and Mella are very well liked among the Norwegian patients.
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I sincerely hope you're right. 2029 is an eternity away. If it's money thats the limiter then we have to pull out all the stops to try and help F&M find the funds. I have a few ideas but I'm badly crashed at the moment.

I would spearhead this initiative if I could. I'm feeling quite angry at my limitations right now.
 
Jonathan Edwards said:
These are still open questions I think. We had very little trouble with low IgG with rituximab because we were careful. In France physicians used it without being careful and there were infection deaths. A lot of protection against viral infections going around is T cell based. It takes too long to make antibody to keep you alive during a new infection anyway. But there is likely to be some increased risk with IgG being low.
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What sort of being careful is involved?
 
V.R.T. said:
I sincerely hope you're right. 2029 is an eternity away. If it's money thats the limiter then we have to pull out all the stops to try and help F&M find the funds. I have a few ideas but I'm badly crashed at the moment.

I would spearhead this initiative if I could. I'm feeling quite angry at my limitations right now.
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I’ve tried to check the numbers assuming money is no issue.

The study lasts for 72 weeks. If the last patient starts in Dec 2026 (current recruitment deadline), they will be done by April 2028.

If getting a preprint out takes 6 months (complete guess), it will be Oct 2028.

If recruitment goes faster, they might be able to be done by early 2028. If they also publish preliminary results after e.g. 40 weeks post treatment, they might be out by late 2027.
 
Utsikt said:
I’ve tried to check the numbers assuming money is no issue.

The study lasts for 72 weeks. If the last patient starts in Dec 2026 (current recruitment deadline), they will be done by April 2028.

If getting a preprint out takes 6 months (complete guess), it will be Oct 2028.

If recruitment goes faster, they might be able to be done by early 2028. If they also publish preliminary results after e.g. 40 weeks post treatment, they might be out by late 2027.
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But if the bottleneck to recruitment is partly money and funding is sorted soon, surely they could be done by mid 2027?

Maybe I'm being naive here. They are already well placed to recruit as you say.
 
V.R.T. said:
But if the bottleneck to recruitment is partly money and funding is sorted soon, surely they could be done by mid 2027?

Maybe I'm being naive here. They are already well placed to recruit as you say.
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If the last person starts their 12 week run in period mid 2026, and they go for 40 weeks follow up for a preprint, the last person will be done mid 2027. Then they have to analyse the data and write the paper, so the second half of 2027 looks like the absolute best case, if my assumptions are fair.
 
Surely if the results are good good, it takes a day or two to figure out once they unblind the data. And they’ll be saying this behind the scenes and plans for a further trial might start up before the preprint is even published?
 
Utsikt said:
I would be extremely surprised if it is recruitment. The interest is massive, and Fluge and Mella are very well liked among the Norwegian patients.
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Maybe, but interest is not the problem anyways. The intramural study also had 500 people submit their application but only managed to recruit 20 patients. The only problem would be recruiting enough people that meet whatever strictness of applied criteria. Since we don't know how that will be handled we don't have any indication of whether that'll be a problem anyways. If they'd be as strict as the NIH was, then it would pose a big problem, if things are more or less similar to Rituximab (barring the additionally present criteria) then things should be fairly simple.

In either case I'm pretty confident that both funding and recruitment will end up just fine, one way or another.
 
EndME said:
Maybe, but interest is not the problem anyways. The intramural study also had 500 people submit their application but only managed to recruit 20 patients. The only problem would be recruiting enough people that meet whatever strictness of applied criteria. Since we don't know how that will be handled we don't have any indication of whether that'll be a problem anyways. If they'd be as strict as the NIH was, then it would pose a big problem, if things are more or less similar to Rituximab (barring the additionally present criteria) then things should be fairly simple.

In either case I'm pretty confident that both funding and recruitment will end up just fine, one way or another.
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Ritux recruited 155 with:
  • Canada criteria
  • Mild to severe
  • Illness duration of 2-15 years
Dara will recruit 66 with:
  • Canada criteria
  • Moderate to severe
  • Illness duration of >2 years
  • Defined start of illness after infection or other immune insult
  • NK ≥ 125 x10^6/L.
Both use exclusion criteria related to Dara and Ritux specifically, but I doubt they make much of a difference.

Ritux included 5 locations, Dara has the two largest cities of those.
 
Utsikt said:
Ritux recruited 155 with:
  • Canada criteria
  • Mild to severe
  • Illness duration of 2-15 years
Dara will recruit 66 with:
  • Canada criteria
  • Moderate to severe
  • Illness duration of >2 years
  • Defined start of illness after infection or other immune insult
  • NK ≥ 125 x10^6/L.
Both use exclusion criteria related to Dara and Ritux specifically, but I doubt they make much of a difference.

Ritux included 5 locations, Dara has the two largest cities of those.
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Yes, those are the known recruitment criteria, which are fairly similar. The point I was making is that the deciding factors would, if they exist, be unknown factors relating to being more or less stringent in the medical assessment and application to who is participating.

I might be misremembering but I think there were some talks by Fluge and Mella in the past years were they were worried about a lack of stringency in the assessment in the past, but I could be wrong. Maybe they'll apply the same stringency as in the Rituximab trial. Then it'll all be no problem.
 
Yann04 said:
And they’ll be saying this behind the scenes and plans for a further trial might start up before the preprint is even published?
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Funding might hold that up, I guess? For a large trial any application would likely need to be based on the results of the previous one, including whether any improvement was sustained over time.

To the normal research world this work probably looks really speculative. No one seems to have worked through a clear theoretical case on why the drug would work—it's more that it seems plausible they're looking in the right forest. To get it accepted they're going to have to meet the evidential standards that apply to any other drug treatment. Their rigorous approach means that it will, as long as it does work.

In the meantime there'll be a lot of scepticism. My worry isn't about the time frame, it's more that if there's a load of unfounded hype and an industry builds up in off-label prescription by what are viewed as fringe doctors, it could make the job of getting the work taken seriously much harder.
 
Kitty said:
In the meantime there'll be a lot of scepticism. My worry isn't about the time frame, it's more that if there's a load of unfounded hype and an industry builds up in off-label prescription by what are viewed as fringe doctors, it could make the job of getting the work taken seriously much harder.
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I’m not sure I agree. But in any case. Dara is getting very little hype in the usual places where I see drugs hyped Reddit/Bluesky/Xitter

the hypers seem far more interested in supplements and antivirals and such
 
EndME said:
Yes, those are the known recruitment criteria, which are fairly similar. The point I was making is that the deciding factors would, if they exist, be unknown factors relating to being more or less stringent in the medical assessment and application to who is participating.

I might be misremembering but I think there were some talks by Fluge and Mella in the past years were they were worried about a lack of stringency in the assessment in the past, but I could be wrong. Maybe they'll apply the same stringency as in the Rituximab trial. Then it'll all be no problem.
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Didn’t know that.

Can it be anything other than the CCC?

Might be that they will require checking if they currently fulfil the criteria, and not just if they’ve ever received the diagnosis.
 
Sasha said:
Good! I can't believe what a stupid name someone dumped on this drug.
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Chatgpt says:

So, daratumumab can be broken down:

-mab = monoclonal antibody

-tu- = tumor (targeting tumors/cancer)

-ma- = human (made from human sequences, vs. chimeric or murine)

dara- = unique prefix, chosen just to make the name distinct
 
Utsikt said:
Didn’t know that.

Can it be anything other than the CCC?

Might be that they will require checking if they currently fulfil the criteria, and not just if they’ve ever received the diagnosis.
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I have no idea how things will work in practice. I'd imagine they'd take a full history, run all the tests they deem as necessary and then make a decision that fits their suit. I'd think that would be quite different from purely using the CCC as checklist but I could be wrong (certainly everyone included will end up meeting CCC).

I was thinking that if for example a patient says that they are naturally very fluctuating with many up and downs that they would then possibly be more inclined to not have that person included even if they check all the boxes, something similar might apply to comorbidities, or maybe they think someone has symptoms that aren't quite fitting (despite fulfilling the CCC), maybe their medical records aren't complete enough etc. But I could be wrong.

I've certainly met patients who've checked all boxes on a list but still ended up not being included in a specific trial (and not because the trial already had too many patients).
 
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Sasha said:
This is a good point. We don't have physician-led centres ready to leap into action. If this dara trial was positive, would that lead immediately to the setting up of such centres, and if so, how immediate would that be? Would we be stuck waiting in our beds another six months, a year, two years? Or would be get referred to specialists who are used to using dara? If so, who would that be? Immunologists? Oncologists?

Do we need to be doing something now to enable swift roll-out?
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Or to make sure there is any rolling out. This goes to a thread I remember @Sasha did recently on what we need to be doing/thinking about in readiness for developments happening in research.

It’s a big concern if it’s infusions etc. as I start thinking indeed it would normally involve having a clinical set up that me/cfs is way off for because the illness just hasn’t been taken seriously even re diagnostics and making sure those with it are separated from it just being ‘people sent off to the fatigue/mus/pps clinic’. And to make sure that all those who have had me/cfs for a long time but aren’t attached to clinics that are physios for new people and perhaps really just political entities seeing the illness as ‘fatigue’ actually are even acknowledged as having the condition and sitting on any theoretical ‘list’ where we are unserved

We could assume people will do the right thing because it exists and could be done but I don’t think there is even a system or list or anything by which we are near that just happening and potentially political type questions then happening of which people get treated with it and how they are identified etc. ?
 
OrganicChilli said:
Chatgpt says:

So, daratumumab can be broken down:

-mab = monoclonal antibody

-tu- = tumor (targeting tumors/cancer)

-ma- = human (made from human sequences, vs. chimeric or murine)

dara- = unique prefix, chosen just to make the name distinct
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ChatGPT doesn't have to say it out loud! It's like Terry Pratchett's Nanny Ogg saying 'banananana'.
 
Sasha said:
Quite possibly! I haven't read stuff properly and am very confused about what stage we're at and what needs to happen next.

OTOH, we don't want to be waiting for the end of a definitive trial to start making roll-out possible, if there are things we need to do to make that happen. For example, PwME have been campaigning for years to get physician-led services and we don't have them. If that's what we'd need for a dara roll-out (or a roll-out of any effective drug), we may need to start serious, joined-up campaigning now. I think we need to think strategically.
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And those who are more severe or had it longer just feel disappeared as we aren’t on anyone’s lists and I’m not sure there is even any entity fighting for us. Who would know who we are or how to make sure we are seen as a priority in any treatment and don’t just get missed out. Given clinics don’t cover us.

I think the idea that a system focused on ignoring us and which has been convinced we have something not medically bad but just have dodgy notes suggesting some kind thing is going to look to do the huge amount of work to locate us and set up treatment for us, when we are the illest and most voiceless is a big assumption.

Particularly when historically it’s not like any of those clinical specialties have necessarily had lots of people who have wanted to go anywhere near us as the misinformation/politics has probably influenced them at least by making it difficult. So I’m not sure if eg ‘x-ology’ ends up being the place it sits that without some sort of pressure from the patient side or elsewhere they are just going to be handed the money or resources to add treating us, nevermind settting it up from scratch into their likely already stretched department and remit?
 
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