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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT03956615
Collaborator
Stichting tegen Kanker (Other)
10
1
1
21.6
0.5

Study Details

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
  • Other: Blood sampling and bone marrow analysis
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 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 :
Feb 12, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. [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 [Within 2 years after study completion]

    Absolute amount of unique sdAbs obtained per patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Brussels Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel
  • Stichting tegen Kanker

Investigators

  • Principal Investigator: Marleen Keyaerts, MD, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03956615
Other Study ID Numbers:
  • UZBRU_MUM
First Posted:
May 21, 2019
Last Update Posted:
Dec 1, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm/Group Description Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Period Title: Overall Study
STARTED 10
COMPLETED 3
NOT COMPLETED 7

Baseline Characteristics

Arm/Group Title Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm/Group Description Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Overall Participants 10
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
4
40%
>=65 years
6
60%
Sex: Female, Male (Count of Participants)
Female
4
40%
Male
6
60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
2
20%
White
7
70%
More than one race
0
0%
Unknown or Not Reported
1
10%
Region of Enrollment (participants) [Number]
Belgium
10
100%

Outcome Measures

1. Primary Outcome
Title Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
Description Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Time Frame Within 2 years after study completion

Outcome Measure Data

Analysis Population Description
Out of 10 patients included, three patients with confirmed surface Ig expression were selected for sdAb generation.
Arm/Group Title Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm/Group Description Only 1 arm/group in this trial
Measure Participants 3
Count of Participants [Participants]
2
20%
2. Primary Outcome
Title Amount of Paraprotein-targeting sdAbs Generated Per Patient
Description Absolute amount of unique sdAbs obtained per patient
Time Frame Within 2 years after study completion

Outcome Measure Data

Analysis Population Description
Per participant, the number of different SdAb generated are reported.
Arm/Group Title Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm/Group Description Only 1 arm/group in this trial
Measure Participants 3
number of different SdAb for subject 1
14
number of different SdAb for subject 2
0
number of different SdAb for subject 5
20

Adverse Events

Time Frame 1 day
Adverse Event Reporting Description
Arm/Group Title Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Arm/Group Description Only 1 arm/group in this trial
All Cause Mortality
Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Affected / at Risk (%) # Events
Total 0/10 (0%)
Serious Adverse Events
Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Affected / at Risk (%) # Events
Total 0/10 (0%)
Other (Not Including Serious) Adverse Events
Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Affected / at Risk (%) # Events
Total 0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Matthias D'Huyvetter
Organization Vrije Universiteit Brussel
Phone +3224776013
Email afspraak_nucleaire@uzbrussel.be
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT03956615
Other Study ID Numbers:
  • UZBRU_MUM
First Posted:
May 21, 2019
Last Update Posted:
Dec 1, 2021
Last Verified:
Mar 1, 2021