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Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.

Blenrep

Thomas W LeBlanc, MD

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics.

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

Treatment use and treatment patterns (dose, length of treatment, delays and dose reductions, reasons for discontinuation) will be summarized using proportions.

Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.

Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.

Time (number of days) elapsed from treatment initiation with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation\[SD\]) and median (with interquartile range \[IQR\]) will be used to summarize duration across participants.

Number of cycles of treatment with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation\[SD\]) and median (with interquartile range \[IQR\]) will be used to summarize duration across participants.

Number of participants who discontinued treatment with BLENREP by reason.

The time from the start of BLENREP treatment until death, with censoring of participants who were alive when last seen or who were lost to follow up.

The percentage of participants with the best overall response: partial response (PR), very good partial response (VFPR), compete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group \[IMWG\] response criteria (if available) or clinician assessment.

The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.

The time from the start of BLENREP treatment to the date of first occurrence of response.

The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.

a. The number of eye exam visits during BLENREP treatment.

Number of participants with specific ocular adverse events of interest (e.g. keratopathy) during treatment with BLENREP

Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.

Distress is measured on a scale of 0-10 on the NCCN DT. The main outcome variable is the occurrence of actionable distress, defined as a NCCN DT score of 4 or higher. The analysis will describe the proportion of clinic visits where actionable distress is reported during treatment with BLENREP, and the frequency of actionable distress over time.

Sources of distress will be assessed using the NCCN DT Problem List by examining the proportion of visits where types of problems are reported (e.g., physical or emotional problems). The frequency of individual types of problems, and the most commonly-reported problems will be examined descriptively.

To the extent that they are available, HCRU (i.e., inpatient admissions, treatment-related outpatient visits, and emergency department visits) will be summarized by the mean (± SD) and median (with IQR) number of events per patient per year and by the proportion and frequency distribution of patients with any occurrence of the respective outcome. Likewise, mean (± SD) and median (with IQR) length of stay per year will be summarized for inpatient visits.

GlaxoSmithKline

Duke University

All Drugs and Chemicals

Antibodies

Immunoglobulins

Belantamab mafodotin will be administered.

Belantamab mafodotin

GSK Clinical Trials

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

Belantamab mafodotin will be administered using various dosing regimens.

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)

IPD for this study will be made available via the Clinical Study Data Request site.

KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea \[Grade 0\] to corneal ulcer \[Grade 4\]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity \[Grade 0\] to visual acuity worse than 1.0 logarithm of the minimum angle of resolution (\[logMAR\] (20/200) \[Grade 4\]). The KVA grade is driven by the most severe finding.

KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea \[Grade 0\] to corneal ulcer \[Grade 4\]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity \[Grade 0\] to visual acuity worse than 1.0 logMAR (20/200) \[Grade 4\]). The KVA grade is driven by the most severe finding.

The exposure adjusted incidence rate is defined as the number of participants with corneal events divided by the total exposure in subject years among participants in the respective treatment group at risk of an initial occurrence of the event.

Median duration of dose delay is defined as the median duration in time of all the dose delays in the respective treatment group.

Cumulative incidence of corneal events by grade is calculated using the KVA scale, as the number of new events divided by the total number of individuals in the population at risk for a specific time interval.

Toxicity Index score is defined as a function of the ordered toxicity grades, where the toxicity grades are represented in descending order by the sequence.

Duration of corneal events is defined as the sum of the duration of all the corneal events of a participant.

Percentage of time on study with corneal events is defined as the duration of corneal events divided by the total amount of time that a participant is on the study in percentage.

BCVA will be assessed as per Snellen (or Snellen-equivalent) chart.

Percentage of participants with a confirmed partial response (PR) or better per International Myeloma Working Group (IMWG) criteria.

Time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

Time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to any cause.

Time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.

Time from the date of randomization until the earliest date of documented PD (according to IMWG Response Criteria) or death due to any cause.

Time from the date of randomization until death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma	NCT05986682	Multiple Myelom...	Blenrep	18 Years - 89 Years	Duke University
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma	NCT05064358	Multiple Myelom...	Belantamab mafo...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for blenrep

Every month we try and update this database with for blenrep cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for blenrep

Every month we try and update this database with for blenrep cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blenrep cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.