Multiple Myeloma
Conditions
Brief 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 mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.
Interventions
DIAGNOSTIC_TESTGallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
Assess somatostatin receptor expression
Sponsors
Jules Bordet Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Somatostatin receptor expression | through study completion, an average of 1,5 year | Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images |
Countries
Belgium
Outcome results
None listed