Myeloma MultipleNCT05887206
Corneal Toxicity in Patients Treated by Belantamab Mafodotin
An observational study of Myeloma Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
Trial summary
Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Collection of datas
- How many people
- 43 participants
- Where
- 10 sitesFrance
- Study dates
- 2 May 2022to 2 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with a refractory multiple myeloma, treated by Belantamab Mafodotin, and an ophthalmologic follow-up between January 2020 and February 2022 will be included.
Who may be able to join
- French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022
- Patients treated by Belantamab Mafodotin
Who cannot join
- Patients with more than 50% of missing ophthalmologic data.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Dijon
Dijon
CHU de Limoges - Hôpital Dupuytren
Limoges
HCL- Croix Rousse
Lyon
Clinique Monticelli-Vélodrome
Marseille
CHRU de Nancy
Nancy
CHU Nice
Nice
APHP - Kremlin-Bicêtre
Paris
CHU Saint-Etienne
Saint-Etienne
CHRU Strasbourg
Strasbourg
CHU Toulouse
Toulouse
About this study
Official title: Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?
Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody.
It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.
Read the detailed description
This study aims at analysing the refractive shifts caused by Microcyst-like Epithelial Changes (MECs) and whether it can be used to monitor patients and facilitate their follow up.
Constitution of a French multicenter cohort.
- Conditions
- Myeloma Multiple
- Being tested
- Collection of datas
- Keywords
- Myeloma, relapsed or refractory multiple myeloma (RRMM), Belantamab mafodotin, microcyst-like epithelial changes (MECs), microcyst, corneal toxicity, refractive shift
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of datasOther
The collected data are : sex, age, date of first immunotherapy cycle, dose, date of first consultation, objective refraction in spheric equivalent, keratometry, visual acuity, microcyst-like epithelial changes (MECs), location and density, corneal toxicity grade and complementary exams (topography, in vivo confocal microscopy).
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by Belantamab Mafodotin | patients treated by Belantamab Mafodotin with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022 will be included.
Data will be collected for patients coming from multiple French centers which followed patients treated by Belantamab Mafodotin between January 2020 and February 2022. They will be obtained by contacting centers through an email sent with a secure mail address. Receives: Other: Collection of datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratopathy and Visual Acuity (KVA) scale
This scale is defined by 4 values : G1, G2, G3 and G4 (the best value is G1)
The severity grade of microcyst-like epithelial changes (MECs) is rated using the Keratopathy and Visual Acuity (KVA) scale after slit lamp examination.
The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Refraction (no unit)
The refraction is measured in spheric equivalent (SEQ) with an automated refractometer
The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Secondary outcomes (4)
Monoyer scale
The score is from 10/10 (best visual acuity) to 1/10 (worth visual acuity) Correlation between visual acuity and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Parinaud scale
The score is from 10/10 (best visual acuity) to 1/10 (worth visual acuity) Correlation between visual acuity and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Keratometry (diopter = 1/m)
Keratometry is measured in diopter using an autorefractometer or a topograph. This device measures the curvature of the anterior corneal surface based on the power of a reflecting surface. It does this by measuring the size of an image reflected from 2 paracentral points and utilizes doubling prisms to stabilize the image enabling more accurate focusing.
Correlation between keratometry and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Epithelial pachymetry (µm)
Epithelial pachymetry is measured in micrometer (µm) using a topograph
Correlation between epithelial pachymetry and severity grade of microcyst-like epithelial changes (MECs)
Measured: Months: 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start2 May 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Caroline TRONE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887206
- Sponsor's protocol ID
- IRBN292021/CHUSTE
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Toxicity in Patients Treated by Belantamab Mafodotin : How to Improve and Facilitate Patients Follow-up Using Refractive Shift ?
- ClinicalTrials.gov ID
- NCT05887206
- Acronym / sponsor ID
- IRBN292021/CHUSTE
- Conditions
- Myeloma Multiple
- Keywords
- Myeloma, relapsed or refractory multiple myeloma (RRMM), Belantamab mafodotin, microcyst-like epithelial changes (MECs), microcyst, corneal toxicity, refractive shift
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Belantamab Mafodotin is the first antibody conjugate targeting B-cell maturation antigen (BCMA) in relapsed or refractory multiple myeloma (RRMM). It is used in multiple myeloma refractory to an immunomodulatory drug or proteasome inhibitor and refractory and/or intolerant to an anti-CD38 monoclonal antibody.
It has been found that the immunotherapy causes corneal side effects, Microcyst-like Epithelial Changes (MECs). They are round-shaped corneal inclusions that migrate from the peripheral cornea to the center, causing blurry vision, dryness and refractive shifts depending on their location and density.
Detailed description
This study aims at analysing the refractive shifts caused by Microcyst-like Epithelial Changes (MECs) and whether it can be used to monitor patients and facilitate their follow up.
Constitution of a French multicenter cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by Belantamab Mafodotin | – | Other: Collection of dataspatients treated by Belantamab Mafodotin with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022 will be included. Data will be collected for patients coming from multiple French centers which followed patients treated by Belantamab Mafodotin between January 2020 and February 2022. They will be obtained by contacting centers through an email sent with a secure mail address. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a refractory multiple myeloma, treated by Belantamab Mafodotin, and an ophthalmologic follow-up between January 2020 and February 2022 will be included.
Key inclusion criteria (2 listed)
- French patients with a refractory multiple myeloma and an ophthalmologic follow-up between January 2020 and February 2022
- Patients treated by Belantamab Mafodotin
Key exclusion criteria (1 listed)
- Patients with more than 50% of missing ophthalmologic data.
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 |
|---|---|---|
| Collection of datasThe collected data are : sex, age, date of first immunotherapy cycle, dose, date of first consultation, objective refraction in spheric equivalent, keratometry, visual acuity, microcyst-like epithelial changes (MECs), location and density, corneal toxicity grade and complementary exams (topography, in vivo confocal microscopy). | Other | Patients treated by Belantamab Mafodotin |
Primary outcome
Keratopathy and Visual Acuity (KVA) scale
Time frame: Months: 24
This scale is defined by 4 values : G1, G2, G3 and G4 (the best value is G1) The severity grade of microcyst-like epithelial changes (MECs) is rated using the Keratopathy and Visual Acuity (KVA) scale after slit lamp examination. The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
Refraction (no unit)
Time frame: Months: 24
The refraction is measured in spheric equivalent (SEQ) with an automated refractometer The aim is to show a correlation between refractive shift and severity grade of microcyst-like epithelial changes (MECs)
4 secondary outcomes
Monoyer scale
Time frame: Months: 24
Parinaud scale
Time frame: Months: 24
Keratometry (diopter = 1/m)
Time frame: Months: 24
Epithelial pachymetry (µm)
Time frame: Months: 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Marie Caroline TRONE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Keratopathy and Visual Acuity (KVA) scale (time frame: Months: 24). 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?
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 2 Jun 2023.