PENTIXAFOR GALLIUM GA-68 for Multiple myeloma | Symptomatic multiple myeloma | Relapsed multiple myeloma

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- HIV positive, active Hepatitis B or C"}
• {"criterion_text":"- Patient under judicial protection"}
• {"criterion_text":"- Childbearing or child breast feeding woman"}
• {"criterion_text":"- Woman or man without effective contraceptive barrier if needed"}
• {"criterion_text":"- eGFR < 50 ml/min by MDRD or CKDEPI"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule"}
• {"criterion_text":"- Known active infection"}
• {"criterion_text":"- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus"}
• {"criterion_text":"- Patient under guardianship or trusteeship"}

Primary endpoints

• {"endpoint_text":"- Sensitivity will be assessed by patient and lesion analysis by defining: o True positive (TP): - lesion positive with [68Ga]Ga-PentixaFor-PET and confirmed by another imaging method (FDG-PET/CT, CT scan or MRI) and follow-up or confirmed by histology. o 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.","definition_or_measurement_approach":"Sensitivity assessed by patient and lesion analysis using definitions: True positive (TP) = lesion positive with [68Ga]Ga-PentixaFor-PET and confirmed by another imaging method (FDG-PET/CT, CT, MRI) and follow-up or histology; False negative (FN) = lesion negative with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET confirmed by CT/MRI/histology or follow-up."}

Secondary endpoints

• {"endpoint_text":"- At the time of initial diagnosis or at relapse, 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.","definition_or_measurement_approach":"Specificity (PPV and NPV) assessed by patient and lesion analysis using same TP and FN definitions as primary endpoint."}
• {"endpoint_text":"- At the time of initial diagnosis or at relapse, the prognostic impact of FDG-PET 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 treatment to death.","definition_or_measurement_approach":"Prognostic impact evaluated via correlation of lesion counts and uptake intensity (SUV) with PFS (time from start of treatment to relapse/progression) and OS (time from start of treatment to death)."}
• {"endpoint_text":"- At the time of initial diagnosis or at relapse, 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","definition_or_measurement_approach":"Discordance defined as FDG-positive/[68Ga]-negative or FDG-negative/[68Ga]-positive lesions at diagnosis or relapse."}
• {"endpoint_text":"- At the time of initial diagnosis or at relapse, [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).","definition_or_measurement_approach":"Quantitative assessment of uptake by SUV and correlation with quantitative biological markers from myelogram including hexokinase gene expression."}
• {"endpoint_text":"- At the time of initial diagnosis or at relapse, 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, oxygen saturation 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).","definition_or_measurement_approach":"Tolerance assessed by clinical monitoring for 1 hour post-injection with collection of heart rate, oxygen saturation and blood pressure before injection, 5–10 min after injection, at ~60 min and at ~80 min."}
• {"endpoint_text":"- At the time of therapeutic evaluation, 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.","definition_or_measurement_approach":"Discordance at therapeutic evaluation defined same as for initial diagnosis: FDG-positive/[68Ga]-negative or FDG-negative/[68Ga]-positive."}
• {"endpoint_text":"- At the time of therapeutic evaluation, 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.","definition_or_measurement_approach":"Prognostic impact post-therapy assessed by changes in uptake (decrease or normalization) and association with PFS and OS."}
• {"endpoint_text":"- At the time of therapeutic evaluation, PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative).","definition_or_measurement_approach":"Assessment of PET results (positive/negative) alongside minimal residual disease status by flow cytometry (positive/negative)."}
• {"endpoint_text":"- At the time of therapeutic evaluation, 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, oxygen saturation and blood pressure) will be collected prior and 5/10 min after [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min).","definition_or_measurement_approach":"Tolerance assessed by clinical monitoring for 1 hour post-injection with collection of heart rate, oxygen saturation and blood pressure before injection, 5–10 min after injection, at ~60 min and at ~80 min."}

France

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

558

Number Of Sites

4

Number Of Participants

60

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France