Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

NCT ID: NCT04379817

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2024-05-23

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

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

Assess somatostatin receptor expression

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

References

Delbart 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. 2025 Aug 28. doi: 10.1007/s00259-025-07500-y. Online ahead of print.

Reference Type: DERIVED

PMID: 40866646 (View on PubMed)

Other Identifiers

IJBMNSSTR

Identifier Type: -

Identifier Source: org_study_id