Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT04379817
• Lead Sponsor: Jules Bordet Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-08
• Status Verified: 2023-03
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Somatostatin receptor expression	through study completion, an average of 1,5 year	Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images

Trial Locations

Locations (1)

Jules Bordet Institute; 🇧🇪 Brussels, Belgium