sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

Universitair Ziekenhuis Brussel10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

Blood sampling and bone marrow analysisOTHER

Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

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

Time frame: Within 2 years after study completion

Amount of Paraprotein-targeting sdAbs Generated Per Patient

Absolute amount of unique sdAbs obtained per patient

Time frame: Within 2 years after study completion

Data from ClinicalTrials.gov

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