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

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ClinicalTrials.gov Identifier: NCT03956615
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
stichting tegen kanker
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Blood sampling and bone marrow analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


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


Primary Outcome Measures :
  1. Fraction of patients (n=5) 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 and amount of sdAb families identified. [ Time Frame: Within 2 years after study completion ]
    Absolute amount of unique sdAbs obtained per patient and its average over all patients with successful generation of sdAb

  3. Affinities of generated paraprotein-targeting sdAbs using BIAcore technology and ELISA techniques. [ Time Frame: Within 2 years after study completion ]
    Reporting of affinity (Kd) of selected sdAb per patient measured using BIAcore and ELISA techniques


Secondary Outcome Measures :
  1. binding capacity to patient-derived myeloma cells (if available) [ Time Frame: Within 10 years after study completion ]
    Binding of paraprotein-targeting sdAb to membrane-expressed paraprotein of multiple myeloma cells, obtained as leftover material from routinely performed bone marrow sampling in the 10 years after inclusion of the study subject, measured by mean fluorescence intensity in flow cytometry and/or semiquantitative scoring after immunohistochemistry staining of samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956615


Contacts
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Contact: UZ Brussel +3224776013 afspraak_nucleaire@uzbrussel.be
Contact: Marleen Keyaerts, MD +3224776013 afspraak_nucleaire@uzbrussel.be

Locations
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Belgium
UZ Brussel Recruiting
Brussels, Belgium, 1090
Contact: Marleen Keyaerts, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
stichting tegen kanker
Investigators
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Principal Investigator: Marleen Keyaerts, MD Universitair Ziekenhuis Brussel

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03956615     History of Changes
Other Study ID Numbers: UZBRU_MUM
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases