Back to resultsCharacterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Belantamab mafodotin
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Myeloma focused on measuring Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma
Eligibility 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.
Sites / Locations
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Participants undergoing IC
Participants undergoing SK
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of participants with abnormality in composition of corneal epithelium after administration of belantamab mafodotin
Corneal tissue samples will be 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
Corneal tissue samples will be collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
Secondary Outcome Measures
Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs) associated with IC or SK procedure
Non-SAEs and SAEs will be collected.
Number of participants with abnormal best corrected visual acuity (BCVA) scores
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.
Number of participants with abnormal corneal symptoms
Number of participants with abnormal corneal symptoms will be evaluated.
Number of participants with abnormal corneal epithelial lesions
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04549363
Brief Title
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
Official Title
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Anticipated)
Study Completion Date
June 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Belantamab mafodotin, Impression cytology, Superficial keratectomy, Relapsed/Refractory multiple myeloma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants undergoing IC
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants undergoing SK
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Belantamab mafodotin
Intervention Description
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 Measure Information:
Title
Number of participants with abnormality in composition of corneal epithelium after administration of belantamab mafodotin
Description
Corneal tissue samples will be collected to evaluate the composition of microcyst-like epithelium observed in participants treated with belantamab mafodotin.
Time Frame
Up to 4 months
Title
Number of participants with abnormality in pathologic characteristics after administration of belantamab mafodotin
Description
Corneal tissue samples will be collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Number of participants with non-serious adverse events (non-SAEs) and serious adverse events (SAEs) associated with IC or SK procedure
Description
Non-SAEs and SAEs will be collected.
Time Frame
Up to 4 months
Title
Number of participants with abnormal best corrected visual acuity (BCVA) scores
Description
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.
Time Frame
Up to 4 months
Title
Number of participants with abnormal corneal symptoms
Description
Number of participants with abnormal corneal symptoms will be evaluated.
Time Frame
Up to 4 months
Title
Number of participants with abnormal corneal epithelial lesions
Description
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.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sandy W Wong
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Praneetha Thulasi
Facility Name
GSK Investigational Site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Anjulie K Quick
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Bennie Hau Jeng
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Malin Hultcrantz
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Hussam Banna
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://clinicalstudydatarequest.com
Learn more about this trial
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
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