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Completed

NCT Number: NCT03956615

sdAb-based TRNT 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling and bone marrow analysis

Other

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

Primary outcomes

  1. 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

  2. Amount of Paraprotein-targeting sdAbs Generated Per Patient

    Time frame: Within 2 years after study completion

    Absolute amount of unique sdAbs obtained per patient

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Stichting tegen Kanker

Registry information

Official study title

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

Acronym: MUM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 21, 2019
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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