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Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

Recruiting
18 years and older
All
Phase 2

Overview

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.

Eligibility

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/1.73m
  • 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

Study details
    Multiple Myeloma
    Multiple Myeloma
    Lymphoproliferative Disorder

NCT04379817

Jules Bordet Institute

5 August 2020

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