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Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called daratumumab on patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). ME/CFS is a condition characterized by extreme fatigue that doesn't improve with rest and can worsen with physical or mental activity. The medication being tested, daratumumab, is given as a subcutaneous injection, which means it is injected under the skin.

The purpose of this study is to evaluate the feasibility and safety of using daratumumab in patients with moderate to severe ME/CFS. The study will involve ten patients who will receive the medication over a period of time. Participants will be monitored for any side effects and changes in their condition. The study aims to gather information on how well patients tolerate the treatment and any potential benefits it may provide.

Throughout the study, researchers will track various aspects of the participants' health, including physical function, bodily pain, and overall activity levels. This will help determine if daratumumab can be a safe and effective treatment option for those suffering from ME/CFS. The study is expected to continue for a set period, allowing researchers to collect comprehensive data on the medication's impact on the disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to specific criteria, ensuring the disease is moderate to severe, and confirming the duration of the disease is at least two years.
The assessment also checks the age requirement (18 to 65 years) and ensures informed consent is signed.
Step 2
Baseline measurements
Baseline measurements are taken to establish a starting point for the study. These include assessments of physical function, bodily pain, and daily activity levels.
The SF36 and DSQ-SF scores are recorded, which are questionnaires used to evaluate health-related quality of life and symptom severity.
Step 3
Treatment phase
The treatment involves receiving subcutaneous injections of daratumumab, a medication known as DARZALEX 1800 mg solution for injection.
The injections are administered according to a schedule determined by the study protocol. The exact frequency and duration of administration are specified in the study guidelines.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any adverse events that may occur.
Follow-up assessments are performed to evaluate changes in physical function, bodily pain, and daily activity levels over a period of 40 weeks from the start of the intervention.
Step 5
End of study evaluation
At the conclusion of the study, a final evaluation is conducted to summarize the findings. This includes a comprehensive review of the safety and effectiveness of the treatment.
The results are compared to the baseline measurements to determine any significant changes in health status.

Who can join the trial?

6 criteria

Have a condition called Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) that is moderate to severe. This means the illness is not mild and affects daily life significantly.
Meet the Canadian consensus criteria for ME/CFS. This is a specific set of guidelines used to diagnose the condition.
Be between the ages of 18 and 65 years old.
Provide a signed informed consent. This means you agree to participate in the study after being informed about what it involves.
Have had the disease for at least two years.
Have a clear start to the illness, such as beginning after an infection.

Who cannot join the trial?

8 criteria

Patients who have a known allergy or severe reaction to the study medication or any of its ingredients.
Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
Patients with a history of certain types of cancer, unless they have been in complete remission for at least 5 years.
Patients with uncontrolled or severe heart problems, such as heart failure or recent heart attack.
Patients with severe liver or kidney disease that is not well managed.
Patients who are pregnant or breastfeeding.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are unable to comply with the study procedures or follow-up visits.

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Verified sites

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Helse Bergen HF
Bergen, Norway
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Oslo Universitetssykehus HF
Oslo, Norway

Trial locations

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Investigated drugs

Daratumumab is an anti-CD38 antibody used in this clinical trial. It is administered through subcutaneous injections. The purpose of using daratumumab in this study is to evaluate its feasibility and safety for patients suffering from moderate to severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This medication is being tested to see if it can help manage the symptoms of ME/CFS by targeting specific cells in the immune system.

Daratumumab

What is already known about the treatment

Daratumumab – This medication is administered through subcutaneous injections. It is currently being studied in clinical trials for its feasibility and safety in treating moderate to severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Daratumumab is primarily used as an anti-CD38 antibody, which means it targets a specific protein on the surface of certain cells, potentially modulating immune responses. It is classified as a monoclonal antibody, a type of medication designed to bind to specific proteins and alter their activity.

Investigated diseases

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome – This disease is characterized by extreme fatigue that cannot be explained by any underlying medical condition. The fatigue worsens with physical or mental activity but does not improve with rest. Other symptoms may include sleep problems, difficulty with memory and concentration, and muscle or joint pain. The condition can vary in severity, with some individuals experiencing mild symptoms and others being severely affected. It often progresses in a fluctuating manner, with periods of improvement and worsening. The exact cause of the disease is unknown, and it can affect people of all ages.