Clinical trial NCT05321862: Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
Official title: Exploratory Study Evaluating the Relevance of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation Less Than 66 Years Included in the Prospective IFM 2020-02.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity
timeFrame: 6 months
Secondary outcomes:
measure: Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.
timeFrame: 1 month
measure: Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.
timeFrame: 1 month
measure: Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.
timeFrame: 1 month and 6 months
measure: Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.
timeFrame: 1 month
measure: Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.
timeFrame: 1 month
measure: Prognostic impact of FDG-PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
timeFrame: 6 months
measure: Link between FDG-PET, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by NGS.
timeFrame: 6 months
measure: Tolerance of [68Ga]Ga-PentixaFor-PET.
timeFrame: 1 month and 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: