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Study on [68Ga]Ga-PentixaFor for Detecting Multiple Myeloma in Patients Under 66 Eligible for Stem Cell Transplantation

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What is this study about?

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 to help detect and understand the disease better. This agent is injected into the body and helps doctors see the cancer cells more clearly during imaging tests. The purpose of the study is to determine how well [68Ga]Ga-PentixaFor can identify cancerous lesions in patients who are newly diagnosed with Multiple Myeloma and are eligible for a specific type of treatment called autologous stem cell transplantation.

Participants in the study will receive an injection of [68Ga]Ga-PentixaFor and undergo imaging tests to see how the agent highlights the cancer cells. The study will also compare the results of these tests with other imaging methods to evaluate the effectiveness of [68Ga]Ga-PentixaFor. The study aims to improve the understanding of how this imaging agent can be used to detect minimal residual disease, which refers to small amounts of cancer cells that may remain after treatment.

Throughout the study, participants will be monitored for any side effects from the [68Ga]Ga-PentixaFor injection, and their vital signs, such as heart rate and blood pressure, will be checked. The study will help determine if this imaging method can provide valuable information for the diagnosis and treatment planning of Multiple Myeloma patients. The trial is expected to continue until December 2028, with the goal of enhancing the detection and management of this disease.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, which means you agree to participate after understanding the study’s purpose and procedures. You can withdraw from the study at any time without affecting your future medical care.

2 screening and eligibility confirmation

During this phase, your medical history and current health status will be reviewed to confirm eligibility. This includes checking your age, health condition, and specific criteria related to multiple myeloma. Blood tests and other assessments may be conducted to ensure you meet the study requirements.

3 baseline assessments

Before starting the study treatment, baseline assessments will be conducted. These may include imaging tests like PET scans to evaluate the presence of multiple myeloma lesions. These assessments help in understanding your current health status and will be used for comparison throughout the study.

4 administration of [68Ga]Ga-PentixaFor

You will receive an injection of [68Ga]Ga-PentixaFor, a solution used for imaging purposes. This is administered through an intravenous injection. The purpose is to help detect multiple myeloma lesions using imaging techniques.

5 imaging and monitoring

After the injection, imaging tests such as PET scans will be performed to detect lesions. You will be monitored for about an hour after the injection to check your heart rate, oxygen levels, and blood pressure. These tests help in assessing the presence and extent of the disease.

6 follow-up assessments

Throughout the study, follow-up assessments will be conducted to monitor your health and the effectiveness of the imaging. These may include additional imaging tests and clinical evaluations to track any changes in your condition.

7 end of study procedures

At the end of the study, final assessments will be conducted to evaluate the overall findings. You will have a final visit where the study team will discuss the results and any further steps regarding your health care.

Who Can Join the Study?

  • Participants must be male or female and between the ages of 18 and 65.
  • Participants must provide voluntary written consent before any study-related procedures.
  • Participants must have a confirmed diagnosis of symptomatic multiple myeloma with specific criteria, such as:
    • Monoclonal plasma cells in the bone marrow at least 10% or a biopsy-proven plasmacytoma.
    • One or more of the following myeloma-defining events:
      • Hypercalcemia: High levels of calcium in the blood.
      • Renal insufficiency: Poor kidney function.
      • Anemia: Low levels of red blood cells.
      • Bone lesions: Damage to the bones visible on scans.
      • Clonal bone marrow plasma cell percentage at least 60%.
      • Involved: uninvolved serum free light chain ratio at least 100.
      • More than one focal lesion on MRI studies.
    • Measurable disease defined by specific levels of certain proteins in the blood or urine.
  • Participants must be newly diagnosed and eligible for high dose therapy and autologous stem cell transplantation.
  • Participants must have an ECOG performance status of 2 or less, which means they are able to carry out all self-care but are unable to carry out any work activities.
  • Participants must have certain laboratory test results within specific ranges, such as:
    • Hemoglobin at least 7.5 g/dL.
    • Absolute neutrophil count at least 1.0 Giga/L.
    • ASAT and ALAT levels no more than 3 times the upper limit of normal.
    • Total bilirubin no more than 3 times the upper limit of normal, with some exceptions.
    • Creatinine clearance at least 40 mL/min/1.73 m².
    • Calcium levels within a certain range.
    • Platelet count at least 50 Giga/L, or 30 Giga/L if certain conditions are met.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control or remain abstinent.
  • Men must agree not to father a child and use a latex condom during the study and for a specified period after the last dose of study drug.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of Multiple Myeloma cannot participate.
  • Patients who are not considered high risk for Multiple Myeloma are excluded.
  • Patients who are not part of the MIDAS study are not eligible.
  • Patients who are outside the specified age range for the study cannot participate.
  • Patients who are not able to undergo a [68Ga]Ga-PentixaFor-PET scan are excluded. This is a special type of imaging test used to detect cancer lesions.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hopital Tenon Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Unllfizhki Hvpjgeisz Pkikf Sdsrhcawemz Clhciee Ftlt Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
15.12.2022

Trial locations

Investigated drugs:

[68Ga]Ga-PentixaFor is a special type of imaging agent used in this clinical trial. It helps doctors see inside the body using a scan called PET, which stands for Positron Emission Tomography. This medication is particularly useful for finding areas affected by multiple myeloma, a type of cancer that affects the bone marrow. By using this imaging agent, doctors can detect both bone marrow lesions and any disease that has spread outside the bone marrow. This helps in understanding the extent of the disease at the time of diagnosis, especially in patients who are at high risk.

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 multiplies rapidly, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells produce a large amount of a single type of antibody, which can cause damage to bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, and kidney problems. The abnormal plasma cells can also form tumors in bones or other tissues, known as plasmacytomas. Over time, the disease can affect multiple areas of the body, leading to various complications.

Trial ID:
2022-500339-35-01
Protocol code:
RC22_0150
NCT ID:
NCT05321862
Trial Phase:
Therapeutic exploratory (Phase II)

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