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Study on [68Ga]Ga-PentixaFor for Staging and Evaluation in Symptomatic Multiple Myeloma Patients in Initial Treatment or Relapse

Verified siteInvestigationalNo placebo
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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 Multiple Myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will use a special imaging agent called [68Ga]Ga-PentixaFor, which is a solution for injection. This agent is designed to help doctors see the cancer more clearly using a type of scan called PET (Positron Emission Tomography). The purpose of the study is to evaluate how well [68Ga]Ga-PentixaFor can detect cancer lesions in patients who are either newly diagnosed or experiencing a relapse of their disease.

Participants in the study will receive an injection of [68Ga]Ga-PentixaFor and then undergo a PET scan. This process will help doctors determine if the imaging agent is effective in identifying cancerous areas in the body. The study will also compare the results of the [68Ga]Ga-PentixaFor PET scan with other imaging methods to see how accurate it is. Additionally, the study will monitor how well patients tolerate the injection and the scan, by checking vital signs like heart rate and blood pressure before and after the procedure.

The study aims to provide valuable information on the use of [68Ga]Ga-PentixaFor in the diagnosis and evaluation of Multiple Myeloma. By understanding how this imaging agent works, doctors hope to improve the way they assess and treat this type of cancer, potentially leading to better outcomes for patients. The study will continue to gather data over time to ensure comprehensive results.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), diagnosis of symptomatic multiple myeloma, and a signed informed consent form.

    The patient must be affiliated with or a beneficiary of the National Health Service.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the presence of multiple myeloma lesions using a specialized imaging technique called [68Ga]Ga-PentixaFor-PET.

    This imaging helps in detecting bone marrow lesions or extra-medullary disease at the time of initial diagnosis or relapse.

  3. Step 3

    Medication administration

    The patient receives an injection of [68Ga]Ga-PentixaFor, a solution administered intravenously.

    Clinical monitoring is performed for one hour after the injection to assess tolerance, including heart rate, oxygen saturation, and blood pressure.

  4. Step 4

    Imaging and evaluation

    Approximately 60 minutes after the injection, imaging is conducted to capture the uptake of [68Ga]Ga-PentixaFor in the body.

    The results are analyzed to determine the presence and intensity of lesions, which aids in evaluating the disease's progression or response to treatment.

  5. Step 5

    Follow-up assessments

    Follow-up assessments may be conducted to monitor the disease over time, using the same imaging techniques to compare changes in lesion detection and intensity.

    The impact of these findings on progression-free survival (PFS) and overall survival (OS) is evaluated.

  6. Step 6

    End of participation

    The study is estimated to conclude by September 21, 2031, at which point the patient's participation in the trial will end.

    Final assessments and data collection will be completed to contribute to the study's overall findings.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Must have **symptomatic multiple myeloma**. This means the disease is showing symptoms and needs first-time treatment or has come back after treatment.
  • Must provide **written and signed informed consent**. This means you agree to participate in the study and understand what it involves.
  • Must have an **ECOG score** of less than 2. The ECOG score is a way to measure how well you can perform daily activities. A score of less than 2 means you are mostly able to take care of yourself.
  • Must be **affiliated with or a beneficiary of the National Health Service**. This means you are part of or receive benefits from the national healthcare system.
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Investigated drugs

[68Ga]Ga-PentixaFor is a special imaging agent used in this study to help doctors see areas affected by multiple myeloma, a type of blood cancer. It is used in a PET scan, which is a type of imaging test that helps to detect cancerous lesions in the bone marrow or other parts of the body. This medication helps in identifying the extent of the disease at the time of initial diagnosis or when the disease returns after treatment.

What is already known about the treatment

[68Ga]Ga-PentixaFor – This medication is administered through a PET scan, where it is injected into the body to help visualize certain types of cancer, specifically multiple myeloma. Currently, it is being explored in clinical trials to assess its effectiveness in detecting lesions associated with multiple myeloma, both at initial diagnosis and during relapse. The main therapeutic indication is for the imaging and evaluation of multiple myeloma. At the molecular level, it works by binding to specific receptors that are often overexpressed in cancer cells, allowing for precise imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

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. In this disease, cancerous plasma cells multiply and crowd out healthy blood cells, leading to problems like anemia, infections, and bone damage. As the disease progresses, it can cause bone pain, fractures, and high levels of calcium in the blood. The abnormal plasma cells can also produce a protein that can damage the kidneys. Over time, multiple myeloma can lead to weakened bones and increased risk of infections. The disease often progresses in stages, with symptoms worsening as the number of cancerous cells increases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516752-18-00Protocol codeRC19_0289Estimated enrolment60 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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