Clinical trial NCT04561492: Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 Month
Secondary outcomes:
measure: 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
timeFrame: 1 Month
measure: 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
timeFrame: 1 Month
measure: To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
timeFrame: 1 Month
measure: To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
timeFrame: 1 Month
measure: 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
timeFrame: 1 Month
measure: To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
timeFrame: 1 Month
measure: To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
timeFrame: 1 Month
measure: 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.
timeFrame: 100 Day or 6 Month
measure: 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.
timeFrame: 100 Day and 6 Month
measure: 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.
timeFrame: Every 6 months after the end of treatment
measure: 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
timeFrame: 100 Day or 6 Month
measure: To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET
timeFrame: 100 Day or 6 Month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: HCL
city: Nantes
country: France
facility: Nantes UH
city: Paris
country: France
facility: APHP - Site Tenon
Study officials:
References: