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Belantamab mafodotin for Multiple Myeloma

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 23 months
Awards & highlights

Study Summary

This trial is for people who have received or are currently receiving treatment with belantamab mafodotin for multiple myeloma. The purpose is to get a better understanding of the corneal events seen in some patients receiving this treatment. A small piece of the superficial corneal epithelial tissue will be removed and studied. The trial will last for 4 months and involve 25 patients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 23 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 23 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Abnormality in Composition of Corneal Epithelium After Administration of Belantamab Mafodotin
Number of Participants With Abnormality in Pathologic Characteristics After Administration of Belantamab Mafodotin
Secondary outcome measures
Number of Participants With Adverse Events (AEs)
Number of Participants With Imaging Data Showing Histopathologic Findings

Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants undergoing SKExperimental Treatment1 Intervention
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.
Group II: Participants undergoing ICExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,067,436 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,417 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,914 Total Patients Enrolled
25 Trials studying Multiple Myeloma
3,388 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Belantamab mafodotin been given the green light by the FDA?

"Belantamab mafodotin's safety is estimated to be a 3."

Answered by AI

Are there any available slots left for people who want to participate in this research?

"Yes, this is an ongoing study that was first posted on May 13th, 2021. The primary purpose of the clinical trial is to collect data from 25 participants spread out over 6 sites."

Answered by AI

Is this study being conducted at various locations around the city?

"There are six recruitment sites for this clinical trial, Chapel Hill, Westwood, New york and three other locations. If you are interested in participating in the trial, it would be best to select a site that is nearest to your location to minimize travel requirements."

Answered by AI

What is the standard course of treatment for patients with Belantamab mafodotin?

"Belantamab mafodotin is an immunomodulatory drug that has been approved to treat patients with relapsed or refractory multiple myeloma, as well as those who have previously received treatment with a proteasome inhibitor."

Answered by AI

How many people can sign up for this research project?

"Yes, this is an active clinical trial that was first posted on May 13th, 2021. The most recent update was on September 26th, 2022. They are looking for 25 patients total from 6 different locations."

Answered by AI

Is this a novel clinical study?

"As of now, there are 33 on-going trials for Belantamab mafodotin in 221 cities and 34 countries. The first clinical study was sponsored by Karyopharm Therapeutics Inc in 2015. This initial Phase 1 & 2 trial had 518 participants and completed drug approval stages quickly. In the years since, only 2 more trials have been conducted."

Answered by AI

Is this the first time Belantamab mafodotin has been trialed?

"Belantamab mafodotin was first studied in 2015 at Weill Cornell Medicine / NewYork Presbyterian Hospital. As of now, there are 2 completed trials and 33 active clinical trials. A notable amount of these studies taking place in Chapel Hill, North carolina."

Answered by AI

What are the goals that this clinical trial is hoping to achieve?

"The primary objective of this clinical trial, as stated by the sponsor GlaxoSmithKline, is to evaluate the pathologic characteristics of participants after 4 months. Secondary outcomes being measured over the same time frame include changes in best corrected visual acuity (BCVA) score, corneal symptoms, and corneal epithelial lesions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin
2020. "Characterization of Corneal Epithelial Changes in Participants Treated With Belantamab Mafodotin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549363.
~4 spots leftby Apr 2025
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