Trial Outcomes & Findings for Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (NCT NCT04549363)
NCT ID: NCT04549363
Last Updated: 2023-12-13
Results Overview
Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
Up to approximately 23 months
Results posted on
2023-12-13
Participant Flow
The study has been terminated for reasons pertaining to feasibility.
Out of the 16 participants enrolled, 7 were screen failures, 9 participants were allocated to undergo Impression Cytology (IC)/ Superficial Keratectomy (SK) procedure.
Participant milestones
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
ICSK Population
|
6
|
3
|
|
Overall Study
EICSK Population
|
4
|
2
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Baseline characteristics by cohort
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
n=6 Participants
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
n=3 Participants
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Total
n=9 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
68.5 Years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
71.3 Years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
69.4 Years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 23 monthsPopulation: EICSK population
Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
Outcome measures
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
n=4 Participants
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
n=2 Participants
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
|---|---|---|
|
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 23 monthsPopulation: EICSK population
Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
Outcome measures
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
n=4 Participants
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
n=2 Participants
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
|---|---|---|
|
Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 23 monthsPopulation: ICSK Population
The eye was visualized using a slit-lamp microscope in a procedure room.
Outcome measures
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
n=6 Participants
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
n=3 Participants
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
|---|---|---|
|
Number of Participants With Imaging Data Showing Histopathologic Findings
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 23 monthsPopulation: ICSK population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Participants Allocated to Undergo Impression Cytology Procedure
n=6 Participants
A superficial corneal epithelial tissue specimen was obtained by performing impression cytology (IC) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
Participants Allocated to Undergo Superficial Keratectomy Procedure
n=3 Participants
A superficial corneal epithelial tissue specimen was obtained by performing superficial keratectomy (SK) procedure in participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. The procedure was only performed in one eye. Participants did not need to be on active treatment.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
0 Participants
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0 Participants
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Adverse Events
Participants Allocated to Undergo Impression Cytology Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Allocated to Undergo Superficial Keratectomy Procedure
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
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER