Multiple Myeloma
Conditions
Keywords
Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma
Brief summary
This study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. Participants do not need to be on active treatment. The purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (RRMM) treated with belantamab mafodotin. A superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (IC) or superficial keratectomy (SK) procedure in participants treated with belantamab mafodotin. The procedure will only be performed in one eye, most affected by the corneal epithelial changes. This specimen will undergo pathologic examination and composition analysis.
Interventions
DRUGBelantamab mafodotin
Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 years or older (at the time consent is obtained). * Capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form. * Participants with RRMM who have received or are currently receiving treatment with belantamab mafodotin and diagnosed with microcyst-like epithelial changes (MECs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least one eye. a) If participants only had superficial punctate keratopathy with no evidence of MEC's they are not eligible. * If undergoing SK procedure, treating provider has determined there is no excessive risk to the participant.
Exclusion criteria
* Any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant's safety. * Any excess risk of delayed wound healing (For example, diabetes mellitus). * Do not meet criteria specified by the study or program through which they would receive belantamab mafodotin. * Any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines). * Any participant with decreased corneal sensation. * Eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis. * An active uveitis including anterior, posterior, or panuveitis in either eye. * Permanent legal blindness in the fellow (non-study) eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin | Up to approximately 23 months | Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin. |
| Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin | Up to approximately 23 months | Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Imaging Data Showing Histopathologic Findings | Up to approximately 23 months | The eye was visualized using a slit-lamp microscope in a procedure room. |
| Number of Participants With Adverse Events (AEs) | Up to approximately 23 months | 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. |
Countries
United States
Participant flow
Recruitment details
The study has been terminated for reasons pertaining to feasibility.
Pre-assignment details
Out of the 16 participants enrolled, 7 were screen failures, 9 participants were allocated to undergo Impression Cytology (IC)/ Superficial Keratectomy (SK) procedure.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 3 |
| Total | 9 |
Baseline characteristics
| Characteristic | Participants Allocated to Undergo Impression Cytology Procedure | Participants Allocated to Undergo Superficial Keratectomy Procedure | Total |
|---|---|---|---|
| Age, Continuous | 68.5 Years STANDARD_DEVIATION 9.05 | 71.3 Years STANDARD_DEVIATION 8.5 | 69.4 Years STANDARD_DEVIATION 8.44 |
| Race/Ethnicity, Customized Not Hispanic or Latino | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
Corneal tissue samples were collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
Time frame: Up to approximately 23 months
Population: EICSK population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Allocated to Undergo Impression Cytology Procedure | Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin | 4 Participants |
| Participants Allocated to Undergo Superficial Keratectomy Procedure | Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin | 2 Participants |
Primary
Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
Time frame: Up to approximately 23 months
Population: EICSK population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Allocated to Undergo Impression Cytology Procedure | Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin | 4 Participants |
| Participants Allocated to Undergo Superficial Keratectomy Procedure | Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin | 2 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
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.
Time frame: Up to approximately 23 months
Population: ICSK population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Allocated to Undergo Impression Cytology Procedure | Number of Participants With Adverse Events (AEs) | 0 Participants |
| Participants Allocated to Undergo Superficial Keratectomy Procedure | Number of Participants With Adverse Events (AEs) | 0 Participants |
Secondary
Number of Participants With Imaging Data Showing Histopathologic Findings
The eye was visualized using a slit-lamp microscope in a procedure room.
Time frame: Up to approximately 23 months
Population: ICSK Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Allocated to Undergo Impression Cytology Procedure | Number of Participants With Imaging Data Showing Histopathologic Findings | 2 Participants |
| Participants Allocated to Undergo Superficial Keratectomy Procedure | Number of Participants With Imaging Data Showing Histopathologic Findings | 3 Participants |