Clinical trial · Interventional
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
NCT04379817CI-TRIAL-00078347SCARLETcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Somatostatin receptor expression
- timeFrame
- through study completion, an average of 1,5 year
- description
- Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDDelbart 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. PMID 40866646