Trial Outcomes & Findings for sdAb-based TRNT of Multiple Myeloma: a Feasibility Study (NCT NCT03956615)

NCT ID: NCT03956615

Last Updated: 2021-12-01

Results Overview

Reporting of the relative amount of patients for whom such sdAb could be successfully obtained

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Within 2 years after study completion
• Results posted on: 2021-12-01

Participant Flow

Participant milestones

Measure	Clinically Suspected or Pathologically Confirmed Multiple Myeloma. Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Overall Study STARTED	10
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Clinically Suspected or Pathologically Confirmed Multiple Myeloma. Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Overall Study No multiple myeloma confirmed	2
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 Not selected for sdAb generation, due to limitation of total number to 3	2

Baseline Characteristics

sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

Baseline characteristics by cohort

Measure	Clinically Suspected or Pathologically Confirmed Multiple Myeloma. n=10 Participants Only 1 arm/group in this trial - Patients with a clinically suspected or pathologically confirmed multiple myeloma.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Belgium	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 2 years after study completion

Population: Out of 10 patients included, three patients with confirmed surface Ig expression were selected for sdAb generation.

Reporting of the relative amount of patients for whom such sdAb could be successfully obtained

Outcome measures

Measure	Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. n=3 Participants Only 1 arm/group in this trial
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.	2 Participants

PRIMARY outcome

Timeframe: Within 2 years after study completion

Population: Per participant, the number of different SdAb generated are reported.

Absolute amount of unique sdAbs obtained per patient

Outcome measures

Measure	Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma. n=3 Participants Only 1 arm/group in this trial
Amount of Paraprotein-targeting sdAbs Generated Per Patient number of different SdAb for subject 1	14 unique sdAbs
Amount of Paraprotein-targeting sdAbs Generated Per Patient number of different SdAb for subject 2	0 unique sdAbs
Amount of Paraprotein-targeting sdAbs Generated Per Patient number of different SdAb for subject 5	20 unique sdAbs

Adverse Events

Patients With a Clinically Suspected or Pathologically Confirmed Multiple Myeloma.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthias D'Huyvetter

Vrije Universiteit Brussel

Phone: +3224776013

Email: afspraak_nucleaire@uzbrussel.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place