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NCT Number: NCT04561492

Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma

The aim of our study is to confirm the relevance of PET using [68Ga]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
  • Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
  • ECOG (Eastern Cooperative Oncology Group) < 2
  • Patient affiliated to or beneficiary of the National Health Service

Exclusion criteria

  • HIV positive, active Hepatitis B or C
  • Childbearing or child breast feeding women
  • Women or men without effective contraceptive barrier if needed
  • eGFR < 50 ml/min by MDRD or CKDEPI
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Known active infection
  • Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
  • Patient under guardianship or trusteeship
  • Patient under judicial protection

Treatment and study plan

[68Ga]Ga-PentixaFor

Drug

Tomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor

Primary outcomes

  1. To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis or at relapse.

    Time frame: 1 Month

    Sensitivity will be assessed by patient and lesion analysis by defining:

    • True positive (TP):
    • lesion positive with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET
    • or lesion positive with [68Ga]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation).
    • False negative (FN): - lesion negative with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.

Secondary outcomes

  1. To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET

    Time frame: 1 Month

    The specificity (PPV and NPV) of [68Ga]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective.

  2. To determine at the time of initial diagnosis or at relapse, the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique

    Time frame: 1 Month

    The prognostic impact of PET-FDG and [68Ga]Ga-PentixaFor-PET based on the number of lesions detected and their intensity of uptake by each imaging technique will be evaluated by assessing the impact of these data on the PFS and OS. PFS is defined as the time from the start of treatment to relapse or progression. OS is defined as the time from the start of first treatment to death.

  3. To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET

    Time frame: 1 Month

    Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET

  4. To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET

    Time frame: 1 Month

    Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET

  5. To determine at the initial diagnosis or relapse, the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding

    Time frame: 1 Month

    68Ga]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).

  6. To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET

    Time frame: 1 Month

    Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga-PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga -PentixaFor injection before acquisition (at 60 min)

  7. To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET

    Time frame: 1 Month

    Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min).

  8. To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.

    Time frame: 100 Day or 6 Month

    Investigators will consider as discordant a lesion positive by FDG PET but negative by [68Ga]Ga-PentixaFor-PET and/or a lesion negative by FDG PET but positive by [68Ga]Ga-PentixaFor-PET

  9. To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.

    Time frame: 100 Day and 6 Month

    The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS.

  10. To determine at the time of therapeutic evaluation the prognostic impact of FDG PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.

    Time frame: Every 6 months after the end of treatment

    The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalisation of images on PFS and OS.

  11. To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry

    Time frame: 100 Day or 6 Month

    PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative).

  12. To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET

    Time frame: 100 Day or 6 Month

    Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga -PentixaFor injection. Clinical data (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min).

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment or in Relapse

Acronym: PentiMyelo

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Sep 23, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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