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出境医 / 临床实验 / sdAb-based TRNT of Multiple Myeloma: a Feasibility Study (MUM)

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

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE February 12, 2019
Estimated Primary Completion Date December 31, 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
Official Title  ICMJE sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Other: Blood sampling and bone marrow analysis
Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2031
Estimated Primary Completion Date December 31, 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UZ Brussel +3224776013 afspraak_nucleaire@uzbrussel.be
Contact: Marleen Keyaerts, MD +3224776013 afspraak_nucleaire@uzbrussel.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956615
Other Study ID Numbers  ICMJE UZBRU_MUM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitair Ziekenhuis Brussel
Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Collaborators  ICMJE Stichting tegen Kanker
Investigators  ICMJE
Principal Investigator: Marleen Keyaerts, MD Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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