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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
[68Ga]Ga-PentixaFor
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
  • MM with disease measurable either by serum evaluation of the monoclonal component or by free light chain assay (serum or urinary)
  • 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
  • Respiratory insufficiency defined as DLCO <40% of the corrected value
  • 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

Sites / Locations

  • Nantes UHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[68Ga]Ga-PentixaFor

Arm Description

Outcomes

Primary Outcome Measures

To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis.
Sensitivity will be assessed by patient and lesion analysis by defining: True positive (TP): lesion positive with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET or lesion positive with [68Ga]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation). False negative (FN): - lesion negative with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.

Secondary Outcome Measures

To determine at the time of initial diagnosis, the specificity, the 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.
To determine at the time of initial diagnosis the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique
The prognostic impact of PET-FDG and [68Ga]Ga-PentixaFor-PET based on the number of lesions detected and their intensity 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.
To determine at the time of initial diagnosis the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
Investigators 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
To determine at the time of initial diagnosis the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
Investigators 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
To determine at the time of initial diagnosis the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding
68Ga]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).
To determine at the time of initial diagnosis the 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 (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga -PentixaFor injection before acquisition (at 60 min)
To determine at the time of initial diagnosis the tolerance of [68Ga]Ga-PentixaFor-PET
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min).
To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.
Investigators 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
To determine at the time of therapeutic evaluation the 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 normalisation of images on PFS and OS.
To determine at the time of therapeutic evaluation the 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 normalisation of images on PFS and OS.
To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry
PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative).
To determine at the time of therapeutic evaluation the 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 (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min).

Full Information

First Posted
September 3, 2020
Last Updated
September 24, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04561492
Brief Title
Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma in First Line Treatment
Acronym
PentiMyelo
Official Title
Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
December 21, 2029 (Anticipated)
Study Completion Date
May 21, 2030 (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 therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment. 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 theradiopharmaceutic [68Ga]Ga-PentixaFor
Primary Outcome Measure Information:
Title
To determine the sensitivity of [68Ga]Ga-PentixaFor-PET to detect Multiple Myeloma (MM) lesions [Bone marrow (BM) lesions and/or extra-medullary disease (EMD) ] at the time of initial diagnosis.
Description
Sensitivity will be assessed by patient and lesion analysis by defining: True positive (TP): lesion positive with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET or lesion positive with [68Ga]Ga-PentixaFor-PET, negative on FDG-PET but confirmed by another CT scan/ MRI or histology, or confirmed by follow-up (until therapeutic evaluation). False negative (FN): - lesion negative with [68Ga]Ga-PentixaFor-PET and positive by FDG-PET and confirmed by CT or MRI or histology, or confirmed by follow-up.
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
To determine at the time of initial diagnosis, the specificity, the 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
To determine at the time of initial diagnosis the prognostic impact of FDG PET and of [68Ga]Ga-PentixaFor-PET depending on the positivity, number and intensity of uptake detected by each imaging technique
Description
The prognostic impact of PET-FDG and [68Ga]Ga-PentixaFor-PET based on the number of lesions detected and their intensity 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
To determine at the time of initial diagnosis the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
Description
Investigators 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
Title
To determine at the time of initial diagnosis the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
Description
Investigators 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
Title
To determine at the time of initial diagnosis the correlation between PET-FDG and [68Ga]Ga-PentixaFor-PET uptakes evaluated by SUV and the cytogenetic data evaluated on the myelogram (particularly the measurement of the expression of the gene coding
Description
68Ga]Ga -PentixaFor and FDG uptakes assessed by SUV and the quantitative expression of biological markers on myelogram (including expression of the gene coding for hexokinases).
Time Frame
1 Month
Title
To determine at the time of initial diagnosis the 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 (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga -PentixaFor injection before acquisition (at 60 min)
Time Frame
1 Month
Title
To determine at the time of initial diagnosis the tolerance of [68Ga]Ga-PentixaFor-PET
Description
Tolerance of [68Ga]Ga-PentixaFor will be assessed by clinical monitoring of the patientat the end of acquisition (at approximately 80 min).
Time Frame
1 Month
Title
To determine at the time of therapeutic evaluation the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET and if available their link with histology.
Description
Investigators 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
100 Day or 6 Month
Title
To determine at the time of therapeutic evaluation the 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 normalisation of images on PFS and OS.
Time Frame
100 Day and 6 Month
Title
To determine at the time of therapeutic evaluation the 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 normalisation of images on PFS and OS.
Time Frame
Every 6 months after the end of treatment
Title
To determine at the time of therapeutic evaluation the link between PET-FDG, [68Ga]Ga-PentixaFor-PET results and minimal residual disease evaluated by flow cytometry
Description
PET-FDG, [68Ga]Ga-PentixaFor-PET results (positive/negative) and minimal residual disease evaluated by flow cytometry (positive/negative).
Time Frame
100 Day or 6 Month
Title
To determine at the time of therapeutic evaluation the 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 (heart rate, respiratory rate and blood pressure) will be collected prior [68Ga]Ga-PentixaFor injection before acquisition (at 60 min) and at the end of acquisition (at approximately 80 min).
Time Frame
100 Day or 6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment MM with disease measurable either by serum evaluation of the monoclonal component or by free light chain assay (serum or urinary) 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 Respiratory insufficiency defined as DLCO <40% of the corrected value 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Bodet Milin, MD, PhD
Phone
0033240084143
Email
caroline.milin@chu-nantes.fr
Facility Information:
Facility Name
Nantes UH
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Bodet-Milin, MD, PhD
Email
caroline.milin@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Caroline Bodet Milin, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma in First Line Treatment

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