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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

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04177823
67%
Blood lactate dehydrogenase increased
67%
Lymphocyte count decreased
67%
Platelet count decreased
67%
Hyponatraemia
50%
Hypocalcaemia
50%
White blood cell count decreased
50%
Aspartate aminotransferase increased
50%
Neutrophil count decreased
50%
Hyperphosphataemia
50%
Pyrexia
33%
Alanine aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Hypercalcaemia
33%
Hyperuricaemia
33%
Hypokalaemia
33%
Hypomagnesaemia
33%
Punctate keratitis
33%
Vision blurred
17%
Hyperglycaemia
17%
Myelosuppression
17%
Liver injury
17%
Adenosine deaminase increased
17%
Alpha hydroxybutyrate dehydrogenase increased
17%
Glycocholic acid increased
17%
Protein total decreased
17%
Crystal urine present
17%
Gamma-glutamyltransferase increased
17%
Leucine aminopeptidase increased
17%
Lymphocyte count increased
17%
Prealbumin decreased
17%
Total bile acids increased
17%
Urinary occult blood
17%
Visual impairment
17%
Leukocytosis
17%
Thrombocytopenia
17%
Mouth ulceration
17%
Lung disorder
17%
Hypertension
17%
Electrocardiogram QT prolonged
17%
Trigeminal neuralgia
17%
Purpura
17%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belantamab Mafodotin

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
4,758 Previous Clinical Trials
8,104,114 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,417 Patients Enrolled for Multiple Myeloma
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,924 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 May 2025
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