Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

NCT04549363 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 214098
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Myeloma

Keywords

Belantamab mafodotin; Impression cytology; Superficial keratectomy; Relapsed/Refractory multiple myeloma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Number of Participants With Imaging Data Showing Histopathologic Findings

  Up to approximately 23 months

• Number of Participants With Adverse Events (AEs)

  Up to approximately 23 months

Study Arms (2)

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.

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.

Drug: Belantamab mafodotin

Interventions

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.

Participants undergoing IC; Participants undergoing SK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

San Francisco, California, 94143, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30322, United States

Location

GSK Investigational Site

Westwood, Kansas, 66205, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (1)

• 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.

  PMID: 40338596 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: December 21, 2020
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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 Criteria: 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.

Locations

US (6)