TheranosticTrials.org

Clinical Trial · NCT05321862

Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.

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 detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga-PentixaFor/FDG discordances explored.

Sponsor

Nantes University Hospital

Phase

Phase 2

ClinicalTrials.gov

NCT05321862

Drug / Compound

Pentixafor

Isotope(s):
Target(s):
  • CXCR4
Ligand Class: Peptides
Chelator: DOTA
Linker: AMBS

Eligibility

Inclusion

  • Inclusion criteria are identical to inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) .

Exclusion

  • eGFR \< 50 ml/min by MDRD or CKDEPI.
  • Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with:
  • 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.
  • Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.