NCT04379817CompletedPhase 2
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Source: ClinicalTrials.gov · Last updated 27 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 14 Apr 2020
- Start date
- 25 Feb 2020
- Primary completion date
- 23 May 2024
- Lead sponsor
- Jules Bordet Institute
- Diseases
- Multiple myeloma
- NCT number
- NCT04379817
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 23
- From 25 Feb 2020 to the primary completion date, 23 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
- Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
Other illness
- Other active neoplastic disease
Other
- Pregnant or lactating patients
- Eastern Cooperative Oncology Group Performance Status above or equal to 3
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jules Bordet Institute Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.