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

Nantes University Hospital (NUH)

Status and phase

Enrolling

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: [68Ga]Ga-PentixaFor

Study type

Interventional

Funder types

Other

Identifiers

NCT04561492

RC19_0289

2024-516752-18-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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