MyelomaPhase 1MyelofludateNCT03832127
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
A Phase 1 study testing 18F-Fludarabine in people with Myeloma, run by Nantes University Hospital at 7 sites in France.
Trial summary
The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- 18F-Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesFrance
- Study dates
- 9 Sep 2022to 9 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.
- Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations
- MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
- Patient affiliated with a social insurance scheme
- The patient must understand and voluntarily sign the informed consent form
- Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.)
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- Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET.
- Male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last PET.
- HIV serology known to be negative
- Karnofsky ≥ 70 or ECOG 0-1
Who cannot join
- Age under 18 years
- Pregnancy or breastfeeding
- Male or female refusing birth control conditions
- Primary AL amyloidosis and myeloma complicated by amyloidosis
- Neutropenia <1000 PN / mm3
- Thrombocytopenia <70,000 / mm3
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- Hepatic impairment: bilirubin> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
- Renal impairment defined by creatinine clearance <50 ml / min
- History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer
- Severe active infection
- Active infection with known hepatitis B or C virus.
- Patient with insulin-dependent or non-insulin-dependent diabetes mellitus.
- Intolerance or known allergy to any of the study drugs or any of its analogues
- Psychiatric illness that may interfere with participation in the study
- Patient under safeguard of justice
- Intellectual inability to sign informed consent
- Persons protected by law
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 5 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Pacôme Fosse, MD
Pacôme Fosse, MD
- Recruiting
CHU de Brest
Brest, 29000
Pierre Yves Salaün, MD
Pierre Yvese Salaün, MD
- Recruiting
CHU de Caen
Caen, 14000
Nicolas Aide, MD
Nicolas Aide, MD
- Recruiting
CHU de Nantes
Nantes, 44093
Caroline Bodet-Milin, MD
Caroline bodet Milin, MD
- Withdrawn
Centre Eugène Marquis
Rennes, 35000
- Withdrawn
CHU de Rennes
Rennes, 35000
- Recruiting
CHU de Tours
Tours, 37000
Maria Joao Santiago-Ribeiro, MD
Maria Joao Santiago-Ribeiro, MD
About this study
Official title: Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft
The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.
- Conditions
- Myeloma
- Being tested
- 18F-Fludarabine
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FludarabineDrug
Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma
| Study group | Role | What they receive |
|---|---|---|
| Fludatep | Experimental | PET with 18F-Fludarabine Receives: Drug: 18F-Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
The sensitivity of the initial FludaTEP will be evaluated using an optimal reading mode lesion analysis (ie by consensus of experts) by defining :
True positive:
- positive lesion with 18F-Fludarabine and positive with PET-FDG or MRI
- or positive lesion with 18-F-Fludarabine, negative with PET-FDG and MRI, but confirmed by further complementary imaging (CT) or histological examination, or confirmed at follow-up
False negative:
-negative lesion with 18F-Fludarabine and positive FDG-PET and / or MR Lesions positivity in PET-FDG and MRI will be assessed by central reading done by consensus of experts. Lesions positivity with 18F-Fludarabine will be defined by central reading assessed by 2 nuclear physicians experts in hematology with no access to the other exams' results.
Measured: Before treatment
Secondary outcomes (6)
To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode.
The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial assessment will be assessed through an optimal reading mode lesion analysis (ie by consensus of experts) using same true positive and false positive définitions as for the main endpoint and defining: -positive lesion with 18F-Fludarabine but not found or confirmed on an histological examination, or other imaging technique (PET-FDG, MRI +/- Scan) or at follow-up
True negative:
-negative lesion with 18F-Fludarabine and negative with FDG-PET and MRI
Measured: Before treatment
To evaluate the sensitivity, specificity, and positive and negative predictive values of the FludaTEP for the initial balance according to the local reading
The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial balance will be evaluated through lesion analysis based on the local reading investigator center reading using definitions of VP, VN, FP, and FN described above.
Measured: Before treatment
To evaluate the prognostic impact of FDG-PET and FludaTEP on the number of lesions detected by each imaging technique in a population of MM patients in the 1st line therapeutic but not candidates for marrow autograft.
The prognostic impact of FDG-PET and FludaTEP as a function of the number of lesions detected by each imaging technique will be evaluated by evaluating the impact of these data on progression-free survival and overall survival. Progression-free survival is defined as the time between the beginning of treatment of the disease and relapse or progression. Overall survival is defined as the time between the start of treatment and death.
Measured: After treatment
To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation
The prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation will be determined by evaluating the impact of a decrease and a negation of the signal in imaging on an increase in progression-free survival and overall survival.
Measured: Before and After treatment
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities
Correlations between the 18Fludarabine and FDG uptake intensities assessed by SUVs and the quantitative expression of markers measured in flow cytometry and cytogenetic data (in particular the expression of the coding gene for hexokinases) will be measured using Spearman's correlation coefficient.
Measured: Before and After treatment
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities and the cytogenetic data Tolerance to 18F-Fludarabine
Tolerance to 18F-Fludarabine will be evaluated by clinical monitoring during 2 hours following the 18F-Fludarabine injection. Clinical data will be taken prior to the 18F-Fludarabine injection, prior to the data capture at 60min and after the last data capture.
Measured: Before and After treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start9 Sep 2022
- Primary completion9 Sep 2024 (estimated)
- Study completion9 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cyceron
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832127
- Sponsor's protocol ID
- RC18_0055
- Acronym
- Myelofludate
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2018
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft
- ClinicalTrials.gov ID
- NCT03832127
- Acronym / sponsor ID
- Myelofludate / RC18_0055
- Conditions
- Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Cyceron
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Sep 2024 (estimated)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 6 Feb 2019 (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 objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludatep | Experimental | Drug: 18F-FludarabinePET with 18F-Fludarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.
- Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations
- MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
- Patient affiliated with a social insurance scheme
- The patient must understand and voluntarily sign the informed consent form
Key exclusion criteria (17 listed)
- Age under 18 years
- Pregnancy or breastfeeding
- Male or female refusing birth control conditions
- Primary AL amyloidosis and myeloma complicated by amyloidosis
- Neutropenia <1000 PN / mm3
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 |
|---|---|---|
| 18F-FludarabineTwo PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma | Drug | Fludatep |
Primary outcome
Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
Time frame: Before treatment
The sensitivity of the initial FludaTEP will be evaluated using an optimal reading mode lesion analysis (ie by consensus of experts) by defining : True positive: * positive lesion with 18F-Fludarabine and positive with PET-FDG or MRI * or positive lesion with 18-F-Fludarabine, negative with PET-FDG and MRI, but confirmed by further complementary imaging (CT) or histological examination, or confirmed at follow-up False negative: -negative lesion with 18F-Fludarabine and positive FDG-PET and / or MR Lesions positivity in PET-FDG and MRI will be assessed by central reading done by consensus of experts. Lesions positivity with 18F-Fludarabine will be defined by central reading assessed by 2 nuclear physicians experts in hematology with no access to the other exams' results.
6 secondary outcomes
To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode.
Time frame: Before treatment
To evaluate the sensitivity, specificity, and positive and negative predictive values of the FludaTEP for the initial balance according to the local reading
Time frame: Before treatment
To evaluate the prognostic impact of FDG-PET and FludaTEP on the number of lesions detected by each imaging technique in a population of MM patients in the 1st line therapeutic but not candidates for marrow autograft.
Time frame: After treatment
To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation
Time frame: Before and After treatment
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities
Time frame: Before and After treatment
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities and the cytogenetic data Tolerance to 18F-Fludarabine
Time frame: Before and After treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-Fludarabine in people with Myeloma, run by Nantes University Hospital at 7 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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Bodet-Milin, MD (33240084136, caroline.milin@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP) (time frame: Before treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.