Back to resultsRelevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients. (PENTI-MIDAS)
Primary Purpose
Multiple Myeloma
Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
[68Ga]Ga-PentixaFor
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Myeloma
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:
- 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.
- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
Sites / Locations
- CHU de Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68Ga]Ga-PentixaFor
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.
[68Ga]Ga-PentixaFor and FDG uptakes assessed by SUV.
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.
[68Ga]Ga-PentixaFor and FDG uptakes assessed by the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).
Prognostic impact of FDG-PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalization of images on PFS and OS.
Link between FDG-PET, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by NGS.
FDG-PET, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by NGS (positive/negative).
Tolerance of [68Ga]Ga-PentixaFor-PET.
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga-PentixaFor injection. Clinical data will be collected prior and 5/10 min after [68Ga]Ga-PentixaFor injection before acquisition (at 60 min after the injection) and at the end of acquisition (at approximately 80 min after the injection).
Full Information
NCT ID
NCT05321862
First Posted
March 24, 2022
Last Updated
April 4, 2022
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05321862
Brief Title
Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
Acronym
PENTI-MIDAS
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[68Ga]Ga-PentixaFor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-PentixaFor
Intervention Description
Tomography by Emission of Positons (PET) with the radiopharmaceutic [68Ga]Ga-PentixaFor
Primary Outcome Measure Information:
Title
Sensitivity
Description
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 Outcome Measure Information:
Title
Specificity, positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET.
Description
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
Title
Prognostic impact of FDG-PET and of [68Ga]Ga-PentixaFor-PET depending on the uptake detected by each imaging technique.
Description
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
Title
Discrepancies rate between FDG-PET and [68Ga]Ga-PentixaFor-PET and factors associated with.
Description
* 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
Title
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV.
Description
[68Ga]Ga-PentixaFor and FDG uptakes assessed by SUV.
Time Frame
1 month
Title
Correlation between FDG-PET and [68Ga]Ga-PentixaFor-PET uptakes evaluated by the RNAseq data evaluated on the myelogram.
Description
[68Ga]Ga-PentixaFor and FDG uptakes assessed by the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).
Time Frame
1 month
Title
Prognostic impact of FDG-PET and [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique.
Description
The prognostic impact of [68Ga]Ga-PentixaFor-PET after therapy will be determined by evaluating the impact of a decrease uptake and/or a normalization of images on PFS and OS.
Time Frame
6 months
Title
Link between FDG-PET, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by NGS.
Description
FDG-PET, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by NGS (positive/negative).
Time Frame
6 months
Title
Tolerance of [68Ga]Ga-PentixaFor-PET.
Description
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patient for 1 hour after [68Ga]Ga-PentixaFor injection. Clinical data will be collected prior and 5/10 min after [68Ga]Ga-PentixaFor injection before acquisition (at 60 min after the injection) and at the end of acquisition (at approximately 80 min after the injection).
Time Frame
1 month and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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.
Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline BODET-MILIN
Phone
0033240084143
Email
caroline.milin@chu-nantes.fr
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline BODET-MILIN
Phone
0033240084143
Email
caroline.milin@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Astrid GARREAU
Phone
0033253482840
Email
astrid.garreau@chu-nantes.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.
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