Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

  • STATUS
    Recruiting
  • days left to enroll
    36
  • participants needed
    20
  • sponsor
    Jules Bordet Institute
Updated on 15 October 2021
measurable disease
bone marrow procedure
bortezomib
carfilzomib
daratumumab
refractory multiple myeloma

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.

Details
Condition Lymphoproliferative Disorder, Multiple Myeloma, multiple myeloma (mm), Lymphoproliferative disorders
Treatment Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
Clinical Study IdentifierNCT04379817
SponsorJules Bordet Institute
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

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
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