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Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin

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ClinicalTrials.gov Identifier: NCT04549363
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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. Study duration will be approximately 4 months. Approximately 25 participants will be enrolled in the study.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : February 16, 2022
Estimated Study Completion Date : February 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Participants undergoing IC
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
Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.

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




Primary Outcome Measures :
  1. Number of participants with abnormality in composition of corneal epithelium after administration of belantamab mafodotin [ Time Frame: Up to 4 months ]
    Corneal tissue samples will be collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.

  2. Number of participants with abnormality in pathologic characteristics after administration of belantamab mafodotin [ Time Frame: Up to 4 months ]
    Corneal tissue samples will be collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.


Secondary Outcome Measures :
  1. Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs) associated with IC or SK procedure [ Time Frame: Up to 4 months ]
    Non-SAEs and SAEs will be collected.

  2. Number of participants with abnormal best corrected visual acuity (BCVA) scores [ Time Frame: Up to 4 months ]
    Number of participants with abnormal BCVA scores will be evaluated. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of visual acuity.

  3. Number of participants with abnormal corneal symptoms [ Time Frame: Up to 4 months ]
    Number of participants with abnormal corneal symptoms will be evaluated.

  4. Number of participants with abnormal corneal epithelial lesions [ Time Frame: Up to 4 months ]
    Imaging of the corneal epithelial lesions will be done from slit-lamp examination and/or confocal microscopy, for evaluation of corneal epithelial lesions. Number of participants with abnormal corneal epithelial lesions will be evaluated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549363


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
San Francisco, California, United States, 94143
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sandy W Wong         
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Praneetha Thulasi         
United States, Kansas
GSK Investigational Site Recruiting
Westwood, Kansas, United States, 66205
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anjulie K Quick         
United States, Maryland
GSK Investigational Site Recruiting
Baltimore, Maryland, United States, 21201
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Wuqaas Mirza Munir         
United States, New York
GSK Investigational Site Recruiting
New York, New York, United States, 10065
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Malin Hultcrantz         
United States, North Carolina
GSK Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hussam Banna         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04549363    
Other Study ID Numbers: 214098
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Belantamab mafodotin
Impression cytology
Superficial keratectomy
Relapsed/Refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases