Multiple Myeloma
Conditions
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.
Interventions
OTHERBlood sampling and bone marrow analysis
Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)
Sponsors
Stichting tegen Kanker
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinically Suspected or Pathologically Confirmed Multiple Myeloma. Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Assessment of membrane-expressed ideotypic paraprotein not possible due to low CD38 signals | 1 |
| Overall Study | No expression of ideotypic paraprotein on membrane | 2 |
| Overall Study | No multiple myeloma confirmed | 2 |
| Overall Study | Not selected for sdAb generation, due to limitation of total number to 3 | 2 |
Baseline characteristics
| Characteristic | Clinically Suspected or Pathologically Confirmed Multiple Myeloma. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment Belgium | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Amount of Paraprotein-targeting sdAbs Generated Per Patient
Absolute amount of unique sdAbs obtained per patient
Time frame: Within 2 years after study completion
Population: Per participant, the number of different SdAb generated are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Amount of Paraprotein-targeting sdAbs Generated Per Patient | number of different SdAb for subject 1 | 14 unique sdAbs |
| Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Amount of Paraprotein-targeting sdAbs Generated Per Patient | number of different SdAb for subject 2 | 0 unique sdAbs |
| Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Amount of Paraprotein-targeting sdAbs Generated Per Patient | number of different SdAb for subject 5 | 20 unique sdAbs |
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
Time frame: Within 2 years after study completion
Population: Out of 10 patients included, three patients with confirmed surface Ig expression were selected for sdAb generation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. | Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein. | 2 Participants |