NCT03956615CompletedNot Applicable
sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
Universitair Ziekenhuis Brussel2 sites in 1 country10 target enrollmentStarted: February 12, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Amount of Paraprotein-targeting sdAbs Generated Per Patient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Amount of Paraprotein-targeting sdAbs Generated Per Patient
Time Frame: Within 2 years after study completion
Absolute amount of unique sdAbs obtained per patient
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
Time Frame: Within 2 years after study completion
Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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