Multiple MyelomaPhase 2PentiMyeloNCT04561492
Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma
A Phase 2 study testing [68Ga]Ga-PentixaFor in people with Multiple Myeloma, run by Nantes University Hospital at 3 sites in France.
Trial 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 or in relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- [68Ga]Ga-PentixaFor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Sep 2021to 21 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
- 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
Who cannot join
- HIV positive, active Hepatitis B or C
- Childbearing or child breast feeding women
- Women or men without effective contraceptive barrier if needed
- 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
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- Known active infection
- Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
- Patient under guardianship or trusteeship
- Patient under judicial protection
Trial locations and contacts
3 sites in 1 country.
About this study
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 or in Relapse
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 or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.
- Conditions
- Multiple Myeloma
- Being tested
- [68Ga]Ga-PentixaFor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaForDrug
Tomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | Not described Receives: Drug: [68Ga]Ga-PentixaFor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 or at relapse.
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.
Measured: 1 Month
Secondary outcomes (12)
To determine at the time of initial diagnosis or at relapse, 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.
Measured: 1 Month
To determine at the time of initial diagnosis or at relapse, 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.
Measured: 1 Month
To determine at the time of initial diagnosis or at relapse, 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
Measured: 1 Month
To determine at the time of initial diagnosis or at relapse, 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
Measured: 1 Month
To determine at the initial diagnosis or relapse, 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).
Measured: 1 Month
To determine at the time of initial diagnosis or at relapse, 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)
Measured: 1 Month
To determine at the time of initial diagnosis or at relapse, 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).
Measured: 1 Month
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
Measured: 100 Day or 6 Month
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.
Measured: 100 Day and 6 Month
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.
Measured: Every 6 months after the end of treatment
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).
Measured: 100 Day or 6 Month
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).
Measured: 100 Day or 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start21 Sep 2021
- Primary completion21 Dec 2029 (estimated)
- Study completion21 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561492
- Sponsor's protocol ID
- RC19_0289
- Other IDs
- 2024-516752-18-00
- Acronym
- PentiMyelo
- Status last verified
- Apr 2026
- First submitted
- 3 Sep 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Francois C, Carlier T, Touzeau C, Janz A, Dubegny C, Jamet B, Kraeber-Bodere F, Bailly C, Bodet-Milin C. Optimal acquisition time of [68Ga]Ga-PentixaFor PET/CT for initial staging of multiple myeloma: an ancillary study to the PentiMyelo protocol. EJNMMI Res. 2026 Mar 13;16(1):67. doi: 10.1186/s13550-026-01410-2.
PubMed 41820762
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 or in Relapse
- ClinicalTrials.gov ID
- NCT04561492
- Acronym / sponsor ID
- PentiMyelo / RC19_0289
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 21 Dec 2029 (estimated)
- Study completion
- 21 May 2030 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PentixaFor | Experimental | Drug: [68Ga]Ga-PentixaFor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
- 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
Key exclusion criteria (10 listed)
- HIV positive, active Hepatitis B or C
- Childbearing or child breast feeding women
- Women or men without effective contraceptive barrier if needed
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-PentixaForTomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor | Drug | [68Ga]Ga-PentixaFor |
Primary outcome
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 or at relapse.
Time frame: 1 Month
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.
12 secondary outcomes
To determine at the time of initial diagnosis or at relapse, the specificity, the positive predictive value (PPV) and negative predictive value (NPV) of [68Ga]Ga-PentixaFor-PET
Time frame: 1 Month
To determine at the time of initial diagnosis or at relapse, 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
Time frame: 1 Month
To determine at the time of initial diagnosis or at relapse, the discrepancies rate between FDG PET and [68Ga]Ga-PentixaFor-PET
Time frame: 1 Month
To determine at the time of initial diagnosis or at relapse, the factors associated with discrepancies between FDG PET and [68Ga]Ga-PentixaFor-PET
Time frame: 1 Month
To determine at the initial diagnosis or relapse, 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
Time frame: 1 Month
To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
Time frame: 1 Month
To determine at the time of initial diagnosis or at relapse, the tolerance of [68Ga]Ga-PentixaFor-PET
Time frame: 1 Month
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.
Time frame: 100 Day or 6 Month
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.
Time frame: 100 Day and 6 Month
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.
Time frame: Every 6 months after the end of treatment
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
Time frame: 100 Day or 6 Month
To determine at the time of therapeutic evaluation the tolerance of [68Ga]Ga-PentixaFor-PET
Time frame: 100 Day or 6 Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41820762Francois C, Carlier T, Touzeau C, Janz A, Dubegny C, Jamet B, Kraeber-Bodere F, Bailly C, Bodet-Milin C. Optimal acquisition time of [68Ga]Ga-PentixaFor PET/CT for initial staging of multiple myeloma: an ancillary study to the PentiMyelo protocol. EJNMMI Res. 2026 Mar 13;16(1):67. doi: 10.1186/s13550-026-01410-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-PentixaFor in people with Multiple Myeloma, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 or at relapse. (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04561492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.