Back to resultsSomatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients (SCARLET)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
Sponsored by
About this trial
This is an interventional screening trial for Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Jules Bordet InstituteRecruiting
Outcomes
Primary Outcome Measures
Somatostatin receptor expression
Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379817
Brief Title
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Acronym
SCARLET
Official Title
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT
Intervention Description
Assess somatostatin receptor expression
Primary Outcome Measure Information:
Title
Somatostatin receptor expression
Description
Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
Time Frame
through study completion, an average of 1,5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Delbart
Phone
+3225413005
Email
wendy.delbart@bordet.be
Facility Information:
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Delbart
Phone
+3225413005
Email
wendy.delbart@bordet.be
First Name & Middle Initial & Last Name & Degree
Patrick Flamen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nathalie Meuleman, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
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