Multiple Myeloma Clinical Trial
— SCARLETOfficial title:
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Jules Bordet Institute | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Jules Bordet Institute |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Somatostatin receptor expression | Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images | through study completion, an average of 1,5 year |
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