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| Name | Class |
|---|---|
| Stichting tegen Kanker | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Other | Patients with a clinically suspected or pathologically confirmed multiple myeloma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling and bone marrow analysis | Other | Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. | Reporting of the relative amount of patients for whom such sdAb could be successfully obtained | Within 2 years after study completion |
| Amount of Paraprotein-targeting sdAbs Generated Per Patient | Absolute amount of unique sdAbs obtained per patient | Within 2 years after study completion |
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Inclusion Criteria:
Patients will only be included in the study if they meet all of the following criteria:
Exclusion Criteria:
Patients will not be included in the study if one of the following criteria applies:
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| Name | Affiliation | Role |
|---|---|---|
| Marleen Keyaerts, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | 1090 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. | Reporting of the relative amount of patients for whom such sdAb could be successfully obtained | Out of 10 patients included, three patients with confirmed surface Ig expression were selected for sdAb generation. | Posted | Count of Participants | Participants | Within 2 years after study completion |
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|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Only 1 arm/group in this trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthias D'Huyvetter | Vrije Universiteit Brussel | +3224776013 | afspraak_nucleaire@uzbrussel.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2019 | Mar 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Not selected for sdAb generation, due to limitation of total number to 3 |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Amount of Paraprotein-targeting sdAbs Generated Per Patient | Absolute amount of unique sdAbs obtained per patient | Per participant, the number of different SdAb generated are reported. | Posted | Number | unique sdAbs | Within 2 years after study completion |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
|
| number of different SdAb for subject 5 |
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