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

RC19_0289

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. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.

2021-09-21

2029-12-21

2030-05-21

Recruiting

Early phase I

45

Inclusion Criteria: * Age ≥ 18 years * Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment * MM with disease measurable either by serum evaluation of the monoclonal component or by free light chain assay (serum or urinary) * 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 * Respiratory insufficiency defined as DLCO \<40% of the corrected value * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2023-11-14