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Completed

NCT Number: NCT04379817

Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jules Bordet Institute

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

Assess somatostatin receptor expression

Primary outcomes

  1. Somatostatin receptor expression

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

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

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Acronym: SCARLET

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 8, 2020
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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