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CompletedNCT04379817SCARLETUpdated Jun 27, 2024

Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

A Phase 2 interventional study of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT in Multiple Myeloma, sponsored by Jules Bordet Institute. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Jules Bordet Institute · Phase 2, Interventional, and Screening

Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 23 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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

Phase
Phase 2
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Interventions

  • Diagnostic testGallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT

    Assess somatostatin receptor expression

06

What researchers measure

Primary outcomes

  1. Somatostatin receptor expression

    Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images

    Time frame: through study completion, an average of 1,5 year

07

Study locations

1 site
  • Jules Bordet Institute
    Brussels, 1000, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04379817
Lead sponsor
Jules Bordet Institute
Responsible party
Sponsor
First posted
May 8, 2020
Start date
Feb 25, 2020
Primary completion
May 23, 2024
Completion
May 23, 2024
Last update
Jun 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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