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sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

NCT ID: NCT03956615

Last Updated: 2021-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-12

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinically Suspected or Pathologically Confirmed Multiple Myeloma.

Patients with a clinically suspected or pathologically confirmed multiple myeloma.

Group Type OTHER

Blood sampling and bone marrow analysis

Intervention Type OTHER

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

Interventions

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Blood sampling and bone marrow analysis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stichting tegen Kanker

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marleen Keyaerts, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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UZ Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UZBRU_MUM

Identifier Type: -

Identifier Source: org_study_id