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Study on [68Ga]Ga-PentixaFor PET Imaging for Better Risk and Disease Assessment in Patients with Multiple Myeloma

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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 a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is using a special imaging technique called positron emission tomography (PET) with a new tracer known as [68Ga]Ga-PentixaFor. This tracer is a solution for injection that helps doctors see how the disease is affecting the body. The purpose of the study is to improve the way doctors assess the risk and progression of multiple myeloma using this new imaging method.

Participants in the study will undergo PET scans using the [68Ga]Ga-PentixaFor tracer. These scans will be compared to standard PET scans that use a different tracer called 18F-FDG. The study aims to see if the new tracer provides better information about the disease. The process involves having a baseline scan before starting treatment and possibly additional scans after treatment to observe any changes. The study will look at how well the new tracer detects lesions, which are areas of abnormal tissue, and how it compares to the standard tracer in terms of image quality and diagnostic confidence.

The study will also evaluate the potential of the [68Ga]Ga-PentixaFor tracer to predict patient outcomes and whether it can help classify patients into different risk groups. This could lead to better personalized treatment plans for those with multiple myeloma. The trial is expected to continue until the end of 2025, with the goal of providing valuable insights into the use of this new imaging technique in managing multiple myeloma.

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
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
You must meet certain criteria to participate, such as being diagnosed with multiple myeloma and being eligible for a specific treatment plan.
Step 2
Initial scans
You will undergo a baseline 18F-FDG PET/CT scan. This is a type of imaging test that helps in assessing your condition.
Within 14 days of the initial scan, a [68Ga]Ga-PentixaFor PET/CT scan will be scheduled. This scan uses a special solution injected into your vein to help visualize certain areas in your body.
Step 3
Treatment phase
If you are newly diagnosed and eligible, you will start induction chemotherapy followed by a procedure called ASCT (autologous stem cell transplant).
For those included after ASCT, the scans will be done before starting maintenance therapy with a medication called lenalidomide.
Step 4
Follow-up scans
After your initial treatment, follow-up PET scans will be conducted to compare with the baseline scans. This helps in evaluating the effectiveness of the treatment.
The scans will assess the presence of any lesions and the uptake of the tracer used in the scans.
Step 5
End of study
The study is expected to conclude by the end of 2025. Your participation will help in understanding the effectiveness of the imaging technique used in assessing multiple myeloma.
Your health and progress will be monitored throughout the study duration to ensure your safety and well-being.

Who can join the trial?

9 criteria

All patients who are eligible to start the IMMPROVED study and have signed up for participation can join this study.
Patients must have newly diagnosed Multiple Myeloma and be eligible for a transplant. They should be scheduled for initial chemotherapy followed by ASCT (a type of stem cell transplant). Patients can also join after ASCT, before starting lenalidomide maintenance therapy.
A baseline 18F-FDG PET/CT scan is required. This is a type of imaging test that helps to see how the body is functioning.
WHO performance status should be between 0-2. This is a scale that measures a patient's ability to perform daily activities. If the status is higher than 2, the patient can still participate if the doctor believes they are fit for intensive chemotherapy.
Participants must be 18 years or older.
Participants need to sign an informed consent form, which means they agree to join the study after understanding all the details.
Life expectancy should be more than 12 months, based on the doctor's judgment.
A baseline [68Ga]Ga-PentixaFor PET/CT scan should be scheduled before starting initial chemotherapy. An exception is made for patients joining after ASCT but before lenalidomide maintenance therapy.
The time between the 18F-FDG and [68Ga]Ga-PentixaFor PET/CT scans should not exceed 14 days.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

[68Ga]Ga-PentixaFor is a special type of imaging agent used in a scan called positron emission tomography, or PET for short. This scan helps doctors see inside your body to check for certain diseases, like myeloma, which is a type of cancer. The goal of using this imaging agent is to improve how accurately doctors can assess the risk and presence of the disease. It works by highlighting areas in the body that might be affected by the disease, making it easier for doctors to identify and evaluate them. This can help in planning the best treatment for the patient.

What is already known about the treatment

[68Ga]Ga-PentixaFor – This medication is administered through an injection and is used in a type of imaging test called positron emission tomography (PET) to help assess the risk and progression of multiple myeloma, a type of blood cancer. Currently, it is being studied in clinical trials to determine its effectiveness and accuracy in detecting the disease. The main therapeutic use of [68Ga]Ga-PentixaFor is to improve the assessment of multiple myeloma by providing clearer images of the cancerous cells. At the molecular level, it works by binding to specific targets on the cancer cells, allowing them to be visualized during the PET scan. It is classified as a radiopharmaceutical, which is a type of drug that contains a radioactive substance used for diagnosis or treatment.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. It begins when a single plasma cell becomes abnormal and starts to multiply uncontrollably, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells can produce a large amount of a single type of antibody, which can cause damage to the bones and other organs. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The accumulation of myeloma cells can also interfere with the production of normal blood cells, leading to various complications. Over time, the disease can spread to multiple areas of the body, affecting the bones and other tissues.