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Active (not recruiting) Phase 2 NCT04561492

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

Phase 2 – studying effectiveness and dosage
Conditions: Multiple Myeloma

Sponsor: Nantes University Hospital

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
[68Ga]Ga-PentixaFor
DRUG
Locations 3
France (3)
CHU Bordeaux
Bordeaux
Nantes UH
Nantes
APHP - Site Tenon
Paris
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.09.2021
Completion date
21.05.2030
Registry ID
NCT04561492
Source
clinicaltrials.gov
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