N/A
N=10
sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT03956615 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood sampling and bone marrow analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitair Ziekenhuis Brussel
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. |
2 | — |
| PRIMARY Amount of Paraprotein-targeting sdAbs Generated Per Patient |
14; 0; 20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03956615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.