sdAb-based TRNT of Multiple Myeloma: a Feasibility Study (MUM)

October 27, 2021 updated by: Universitair Ziekenhuis Brussel

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Other: Blood sampling and bone marrow analysis
Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
Time Frame: Within 2 years after study completion
Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Within 2 years after study completion
Amount of Paraprotein-targeting sdAbs Generated Per Patient
Time Frame: Within 2 years after study completion
Absolute amount of unique sdAbs obtained per patient
Within 2 years after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

Stichting tegen Kanker

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2019

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (ACTUAL)

May 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZBRU_MUM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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