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

Nantes University Hospital

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Multiple Myeloma

Interventions

[68Ga]Ga-PentixaForDRUG

Tomography by Emission of Positons (PET) with the radiopharmaceutic \[68Ga\]Ga-PentixaFor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion criteria are identical to inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) . Exclusion Criteria: * Non inclusion criteria are identical to non inclusion criteria in MIDAS study (EudraCT Number: 2020-005216-21, ClinicalTrials.gov Identifier: NCT04934475) added with: 1. eGFR \< 50 ml/min by MDRD or CKDEPI. 2. 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. 3. Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

Sensitivity

To determine the sensitivity of \[68Ga\]Ga-PentixaFor-PET to detect Multiple Myeloma lesions \[Bone marrow (BM) lesions and/or extra-medullary disease (EMD)\] at the time of initial diagnosis in high risk MM patients included in the MIDAS study.

Time frame: 6 months

Secondary Outcomes

Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.

The specificity (PPV and NPV) of \[68Ga\]Ga-PentixaFor-PET at the time of initial diagnosis will be assessed by patient and lesion analysis using the same definitions of TP and FN as for the primary objective.

Time frame: 1 month

Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.

The prognostic impact of FDG-PET and \[68Ga\]Ga-PentixaFor-PET based on the number of lesions detected of uptake by each imaging technique will be evaluated by assessing the impact of these data on the PFS and OS. PFS is defined as the time from the start of treatment to relapse or progression. OS is defined as the time from the start of first treatment to death.

Time frame: 1 month

Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.

\* We will consider as discordant a lesion positive by FDG-PET but negative by \[68Ga\]Ga-PentixaFor-PET and/or a lesion negative by FDG-PET but positive by \[68Ga\]Ga-PentixaFor-PET.

Time frame: 1 month and 6 months

Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.

\[68Ga\]Ga-PentixaFor and FDG uptakes assessed by SUV.

Time frame: 1 month

Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.

Data from ClinicalTrials.gov

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