Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients (SCARLET)

Free University of Brussels (ULB)

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Diagnostic Test: Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT04379817

IJBMNSSTR

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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