Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin (GSK2857916)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Belantamab mafodotin (Drug)
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.
干预措施: Belantamab mafodotin (Drug)
结局指标
主要结局
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
时间窗: 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
时间窗: Up to approximately 23 months
Corneal tissue samples were collected to evaluate pathologic characteristics observed in participants treated with belantamab mafodotin.
次要结局
- 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)