A Phase 2 interventional study of [68Ga]Ga-PentixaFor in Multiple Myeloma, sponsored by Nantes University Hospital. Withdrawn at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Nantes University Hospital · Phase 2, Interventional, and Diagnostic
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 detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years.
The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga-PentixaFor/FDG discordances explored.
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Exclusion Criteria:
Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with:
Drug: [68Ga]Ga-PentixaFor
Tomography by Emission of Positons (PET) with the radiopharmaceutic \[68Ga\]Ga-PentixaFor
Sensitivity
To determine the sensitivity of \[68Ga\]Ga-PentixaFor-PET to detect Multiple Myeloma lesions \[Bone marrow (BM) lesions and/or extra-medullary disease (EMD)\] at the time of initial diagnosis in high risk MM patients included in the MIDAS study.
Time frame: 6 months
Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.
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.
Time frame: 1 month
Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.
The prognostic impact of FDG-PET and \[68Ga\]Ga-PentixaFor-PET based on the number of lesions detected 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.
Time frame: 1 month
Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.
\* We 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.
Time frame: 1 month and 6 months
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.
\[68Ga\]Ga-PentixaFor and FDG uptakes assessed by SUV.
Time frame: 1 month
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.
\[68Ga\]Ga-PentixaFor and FDG uptakes assessed by the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).
Time frame: 1 month
Prognostic impact of FDG-PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
The prognostic impact of \[68Ga\]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalization of images on PFS and OS.
Time frame: 6 months
Link between FDG-PET, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by NGS.
FDG-PET, \[68Ga\]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by NGS (positive/negative).
Time frame: 6 months
Tolerance of [68Ga]Ga-PentixaFor-PET.
Tolerance of \[68Ga\]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after \[68Ga\]Ga-PentixaFor injection. Clinical data will be collected prior and 5/10 min after \[68Ga\]Ga-PentixaFor injection before acquisition (at 60 min after the injection) and at the end of acquisition (at approximately 80 min after the injection).
Time frame: 1 month and 6 months
Plan to share: Undecided
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Nantes University Hospital