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Help us fund the ResetME trial for ME/CFS

The ResetME may confirm a promising pilot-study with Daratumumab. There is hope for ME/CFS patients!

There is no approved, effective treatment for ME/CFS – but you could help us change that!  

A pilot study with the monoclonal antibody daratumumab, an immune-system drug originally developed for cancer, has shown very promising results in a pilot study for ME/CFS patients with post exertional malaise (PEM). Even though the pilot study is encouraging, a larger study with a control group is needed to verify or refute the results. The Haukeland group will conduct a study with 66 patients jointly with Oslo University Hospital. A new, positive study is a prerequisite for advancing daratumumab to be accepted as a treatment for ME/CFS, and also to be an option in other countries. A randomized, controlled trial is already under way – but it needs your help to fully fund it.

You may help!

All donations to ME-Fondet in 2025 are going directly to ResetME. Please give what you can, to help us get answers for people with ME/CFS worldwide. You may pay by credit card using our secure platform for donations . Instructions are in Norwegian but Google should offer to translate each page for you. 

If you live in Britain, you may also contribute through Joan Crawford’s JustGiving page. We are very happy how she is contributing to the fundraising for the ResetME study. 

The pilot-study

The pilot study was carried out by Professors Øystein Fluge and Olav Mella and their ResetME team at Haukeland University Hospital in Norway. They gave 4-7 injections of daratumumab to ten patients who had been diagnosed with ME/CFS 3-25 years ago (median 12) years and fulfilled the Canada Consensus Criteria (CCC). The patients ranged from being mainly housebound to partly bedridden.  

Measured with the standard health survey SF-36, the Haukeland team found that the 10 females in the pilot study split into two groups. Four showed no improvements with the drug, but for the six with clinical response, improvement was marked. Responders started to notice gradual recovery from about 6 weeks after the treatment started, and their physical health status (SF-36 PH) increased week by week. 6 months after the first treatment, the physical health status of the ME patients was at the average for Norwegian women. 

Like other ME patients, at pretreatment they had a wide range of symptoms: fatigue, sleep problems, pain, neurological problems such as brain fog and sensory hypersensitivity, autonomic problems such as nausea and irritable bowel, unsteadiness and balance difficulties when standing up, lack of temperature control and immune problems. All experienced PEM – increased symptom pressure after exertion above a threshold. However, a few weeks after the first treatment, the groups with clinical response experienced milder and less frequent symptoms, with decreasing PEM. A symptom score (DSQ-SF) showed a corresponding reduction of severity in responding patients. In the figures, week 0 is time of the first daratumumab injection 

Milder and less frequent symptoms and better physical health status made it possible to make the ME patients’ dream real. Responders could within weeks increase the rate of physical activity without fear of getting worse.

The Haukeland team believes that ME is caused by an immune response after an infection involving autoantibodies that disrupt the regulation of blood circulation in the body, especially during exertion and stress. Lactic acid builds up very quickly even with little exertion, patients become dizzy and experience brain fog. The drug used in the study, daratumumab, is used especially in bone marrow cancer (myeloma). Because the myeloma cells share the same antigens as normal plasma cells, daratumumab can reduce plasma cells and their products: antibodies. 

The ResetME-team at Haukeland University Hospital 

The ResetME-study

Even though the pilot study is encouraging, a larger study with a control group is needed to verify or refute the results. The Haukeland group will conduct a study for 66 patients together with Oslo University Hospital. 44 patients will receive 7 injections with the monoclonal drug Daratumumab, while 22 other patients will receive a fake treatment. A new, positive double-blind study confirming the results from the pilot is a prerequisite for advancing daratumumab to be accepted as a treatment for ME/CFS, and also to be an option in other countries. 

The ResetME study has important spin-off work on changes in blood factors during the study course that can help in understanding the ME/CFS disease mechanisms better. This is done collaboratively with Prof. Tronstad’s group at University of Bergen and colleagues from other European universities. 

Such a large study as ResetME with good quality control requires a solid financial foundation. With your contribution to the fundraising and your assistance in spreading this information to family, friends and acquaintances, the ME-Fund hope to be able to contribute a new NOK 4 million from the start in June 2025 to the turn of the year 2025/2026. 

We update weekly the amount donated at the bottom of our frontpage ME-Fondet.no

How you can help 

All donations to ME-Fondet are currently going directly to ResetME. Please give what you can, to help us get answers for people with ME/CFS worldwide.  

There are three easy ways to donate:  

• By credit card via our secure platform for donations . Instructions are in Norwegian but Google should offer to translate each page for you. 

• Via international banktransfer via ME-association , using our IBAN: NO6715033204334 and BIC: DNBANOKKXXX. 

• Via PayPal at paypal.com/paypalme/MEnorway

Thank you for giving. Please share the link to this page – every contribution counts. 

More information 

Article about ResetME in online newspaper Nettavisen (via Google auto-English-translation link) 

Scientific paper about the daratumumab pilot trial in academic journal Frontiers in Medicine