Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

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.

Spots Global Cancer Trial Database for gsk2857916

Every month we try and update this database with for gsk2857916 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.

Spots Global Cancer Trial Database for gsk2857916

Every month we try and update this database with for gsk2857916 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 gsk2857916 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.