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The study has been terminated for reasons pertaining to feasibility
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing IC | Experimental | IC will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination and who do not agree to undergo SK. |
|
| Participants undergoing SK | Experimental | SK will be performed on some participants who received or are receiving treatment with belantamab mafodotin for RRMM and have objective evidence of keratopathy with corneal deposits on slit-lamp and/or confocal microscopy examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin | Drug | Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 23 months |
| 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. | Up to approximately 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Imaging Data Showing Histopathologic Findings | The eye was visualized using a slit-lamp microscope in a procedure room. | Up to approximately 23 months |
| Number of Participants With Adverse Events (AEs) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Francisco | California | 94143 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40338596 | Derived | Lee V, Hultcrantz M, Petrone S, Lewis EW, Banna H, Lichtman E, Thulasi P, Quick AA, Jeng BH, Sunshine SB, Francis JH, Canestraro J, Farooq AV, Clements P, Robertson N, Burman M, McKevitt T, Struemper H, Weir L. Characterization of Belantamab Mafodotin-Induced Corneal Changes in Patients With Multiple Myeloma. JAMA Ophthalmol. 2025 Jun 1;143(6):507-514. doi: 10.1001/jamaophthalmol.2025.1008. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Out of the 16 participants enrolled, 7 were screen failures, 9 participants were allocated to undergo Impression Cytology (IC)/ Superficial Keratectomy (SK) procedure.
The study has been terminated for reasons pertaining to feasibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | EICSK population | Posted | Count of Participants | Participants | Up to approximately 23 months |
|
All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 23 months.
Impression cytology or superficial keratectomy procedure (ICSK) population included participants from all-treated population who had a tissue sample collected using IC or SK procedure, whether or not the specimen is evaluable.
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2021 | Nov 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2022 | Nov 21, 2023 | SAP_001.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 |
|---|---|
| C000631691 | belantamab mafodotin |
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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.
| Up to approximately 23 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| GSK Investigational Site | Westwood | Kansas | 66205 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27517 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| 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. |
|
|
| 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. | EICSK population | Posted | Count of Participants | Participants | Up to approximately 23 months |
|
|
|
| Secondary | Number of Participants With Imaging Data Showing Histopathologic Findings | The eye was visualized using a slit-lamp microscope in a procedure room. | ICSK Population | Posted | Count of Participants | Participants | Up to approximately 23 months |
|
|
|
| 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. | ICSK population | Posted | Count of Participants | Participants | Up to approximately 23 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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.
| 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 |