N/A
Completed N=10
sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
Source: ClinicalTrials.gov NCT03956615 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. — 2 Participants
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.
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 | — |
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. Informational only — not medical advice.