Back to resultssdAb-based TRNT of Multiple Myeloma: a Feasibility Study (MUM)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sampling and bone marrow analysis
Sponsored by
About this trial
This is an interventional other trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
Patients will only be included in the study if they meet all of the following criteria:
- Patients who have given informed consent
- Patients at least 18 years old
- Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma.
Exclusion Criteria:
Patients will not be included in the study if one of the following criteria applies:
- Patients who cannot communicate reliably with the investigator
- Patients who are unlikely to cooperate with the requirements of the study
- Patients at increased risk of death from a pre-existing concurrent illness
- Patients who participated already in part I of this study
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm Description
Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Outcomes
Primary Outcome Measures
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Amount of Paraprotein-targeting sdAbs Generated Per Patient
Absolute amount of unique sdAbs obtained per patient
Secondary Outcome Measures
Full Information
NCT ID
NCT03956615
First Posted
April 18, 2019
Last Updated
October 27, 2021
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Stichting tegen Kanker
1. Study Identification
Unique Protocol Identification Number
NCT03956615
Brief Title
sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
Acronym
MUM
Official Title
sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Stichting tegen Kanker
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 aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm Type
Other
Arm Description
Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Intervention Type
Other
Intervention Name(s)
Blood sampling and bone marrow analysis
Intervention Description
Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)
Primary Outcome Measure Information:
Title
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
Description
Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Time Frame
Within 2 years after study completion
Title
Amount of Paraprotein-targeting sdAbs Generated Per Patient
Description
Absolute amount of unique sdAbs obtained per patient
Time Frame
Within 2 years after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will only be included in the study if they meet all of the following criteria:
Patients who have given informed consent
Patients at least 18 years old
Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma.
Exclusion Criteria:
Patients will not be included in the study if one of the following criteria applies:
Patients who cannot communicate reliably with the investigator
Patients who are unlikely to cooperate with the requirements of the study
Patients at increased risk of death from a pre-existing concurrent illness
Patients who participated already in part I of this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marleen Keyaerts, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
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