Multiple MyelomaPhase 3NCT04549363

Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

A Phase 3 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Belantamab mafodotin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 6 sitesUnited States
Study dates: 21 Dec 2020to 21 Nov 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

GSK Investigational Site
Atlanta, Georgia, 30322
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Chapel Hill, North Carolina, 27517
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
San Francisco, California, 94143
GSK Investigational Site
Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)

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.

Conditions: Multiple Myeloma
Being tested: Belantamab mafodotin
Keywords: Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Belantamab mafodotinDrug
Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.

Study groups in NCT04549363
Study group	Role	What they receive
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. Receives: Drug: Belantamab mafodotin
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. Receives: Drug: Belantamab mafodotin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to approximately 23 months

Secondary outcomes (2)

Number of Participants With Imaging Data Showing Histopathologic Findings
The eye was visualized using a slit-lamp microscope in a procedure room.
Measured: Up to approximately 23 months
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.
Measured: Up to approximately 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 202021 Nov 2022

First posted16 Sep 2020
Study start21 Dec 2020
Primary completion21 Nov 2022
Study completion21 Nov 2022

Why it stopped: The study has been terminated for reasons pertaining to feasibility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04549363
Sponsor's protocol ID: 214098
Status last verified: Nov 2023
First submitted: 8 Sep 2020
Last updated: 13 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Expanded access: Available

Publications

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.
PubMed 40338596

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
ClinicalTrials.gov ID: NCT04549363
Acronym / sponsor ID: 214098
Conditions: Multiple Myeloma
Keywords: Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study has been terminated for reasons pertaining to feasibility
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Dec 2020 (actual)
Primary completion: 21 Nov 2022 (actual)
Study completion: 21 Nov 2022 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 13 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Participants undergoing IC	Experimental	Drug: Belantamab mafodotinIC 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	Drug: Belantamab mafodotinSK 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
If undergoing SK procedure, treating provider has determined there is no excessive risk to the participant.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Belantamab mafodotinBelantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.	Drug	Participants undergoing IC, Participants undergoing SK

Primary outcome

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
Time frame: 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
Time frame: Up to approximately 23 months
Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.

2 secondary outcomes

Number of Participants With Imaging Data Showing Histopathologic Findings
Time frame: Up to approximately 23 months
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 23 months

Results and safety

Results posted to the registry on 13 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Allocated to Undergo Impression Cytology Procedure	6	6
Participants Allocated to Undergo Superficial Keratectomy Procedure	3	3

Primary outcome: Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin

Time frame: Up to approximately 23 months. Count of participants. Unit: Participants

Measure	Participants Allocated to Undergo Impression Cytology Procedure n = 4	Participants Allocated to Undergo Superficial Keratectomy Procedure n = 2
Value	4	2

Population analysed: EICSK population

Primary outcome: Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin

Time frame: Up to approximately 23 months. Count of participants. Unit: Participants

Measure	Participants Allocated to Undergo Impression Cytology Procedure n = 4	Participants Allocated to Undergo Superficial Keratectomy Procedure n = 2
Value	4	2

Population analysed: EICSK population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to approximately 23 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Allocated to Undergo Impression Cytology Procedure	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Participants Allocated to Undergo Superficial Keratectomy Procedure	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40338596Lee 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.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belantamab mafodotin in people with Multiple Myeloma, run by GlaxoSmithKline at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin (time frame: Up to approximately 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04549363, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.