Status:
COMPLETED
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Lead Sponsor:
Jules Bordet Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-identifi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04379817
Start Date
February 25 2020
End Date
May 23 2024
Last Update
June 27 2024
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000