sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

Multiple Myeloma Clinical Trial

— MUM  

Official title:

sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956615
• Other study ID #: UZBRU_MUM
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Blood sampling and bone marrow analysis
Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Stichting tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 2 years after study completion
Primary	Amount of Paraprotein-targeting sdAbs Generated Per Patient	Absolute amount of unique sdAbs obtained per patient	Within 2 years after study completion