Multiple MyelomaPhase 2SCARLETNCT04379817
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
A Phase 2 study testing Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT in people with Multiple Myeloma, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing… 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?
- Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Feb 2020to 23 May 2024
- Phase
- Phase 2
- 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
- Age above or equal to 18 years
- Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures
- Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria
- Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab)
- Life expectancy above 3 months
- Active (relapsing or refractory) and measurable disease (on 18F-FDG PET/CT (performed within 4 weeks prior SSTR PET/CT) and biologically)
- Adequate renal function with GFR above or equal to 30mL/min/1.73m²
- Bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive SSTR2 IHC
Who cannot join
- Pregnant or lactating patients
- Other active neoplastic disease
- Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
- Eastern Cooperative Oncology Group Performance Status above or equal to 3
- Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
Trial locations and contacts
1 site in 1 country.
About this study
This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.
- Conditions
- Multiple Myeloma
- Being tested
- Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CTDiagnostic test
Assess somatostatin receptor expression
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatostatin receptor expression
Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
Measured: through study completion, an average of 1,5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start25 Feb 2020
- Primary completion23 May 2024
- Study completion23 May 2024
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.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379817
- Sponsor's protocol ID
- IJBMNSSTR
- Acronym
- SCARLET
- Status last verified
- Mar 2023
- First submitted
- 14 Apr 2020
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delbart W, Karfis I, Vercruyssen M, De Wind R, Meuleman N, Wimana Z, Flamen P, Woff E. The SCARLET trial: a prospective phase II study of somatostatin receptor imaging for potential radiotheranostic application in patients with relapsing and refractory multiple myeloma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1521-1531. doi: 10.1007/s00259-025-07500-y. Epub 2025 Aug 28.
PubMed 40866646
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT04379817
- Acronym / sponsor ID
- SCARLET / IJBMNSSTR
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 8 May 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.
This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above or equal to 18 years
- Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures
- Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria
- Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab)
- Life expectancy above 3 months
Key exclusion criteria (5 listed)
- Pregnant or lactating patients
- Other active neoplastic disease
- Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
- Eastern Cooperative Oncology Group Performance Status above or equal to 3
- Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
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 |
|---|---|---|
| Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CTAssess somatostatin receptor expression | Diagnostic test | – |
Primary outcome
Somatostatin receptor expression
Time frame: through study completion, an average of 1,5 year
Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 40866646Delbart W, Karfis I, Vercruyssen M, De Wind R, Meuleman N, Wimana Z, Flamen P, Woff E. The SCARLET trial: a prospective phase II study of somatostatin receptor imaging for potential radiotheranostic application in patients with relapsing and refractory multiple myeloma. Eur J Nucl Med Mol Imaging. 2026 Feb;53(3):1521-1531. doi: 10.1007/s00259-025-07500-y. Epub 2025 Aug 28.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT in people with Multiple Myeloma, run by Jules Bordet Institute at 1 site in Belgium.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 27 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 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Somatostatin receptor expression (time frame: through study completion, an average of 1,5 year). 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 NCT04379817, 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 27 Jun 2024.