MUM: sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
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 |
---|---|---|
|
N/A |
Study Design
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
- 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
- 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
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.- UZBRU_MUM
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
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%
|
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
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 |
afspraak_nucleaire@uzbrussel.be |
- UZBRU_MUM