The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Belantamab mafodotin will be administered
Dexamethasone will be administered.
Bortezomib will be administered
Percentage of participants with grade greater than or equal to (>=)3 corneal events assessed by keratopathy visual acuity (KVA) scale
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.
Time frame: Up to approximately 4.5 years
Percentage of participants with grade >=3 corneal events assessed by KVA scale up to Month 6
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events.
Time frame: Up to Month 6
Percentage of Participants With Grade >=3 Corneal Events Assessed by KVA scale from 6 to 12 months
KVA scale ranges from 0 to 4 with higher score indicating greater severity of corneal events. Data will be presented for the total number of participants with corneal events in each study group during 6 to 12 months.
Time frame: From 6 to 12 months
Incidence of corneal events as assessed by KVA scale accounting for time on study treatment
KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Time frame: Up to approximately 4.5 years
Percentage of participants with corneal events as assessed by KVA scale
KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Time frame: Up to approximately 4.5 years
Number of recurrences of corneal events as assessed by KVA scale
Number of recurrences of corneal events is defined as the total count of individual corneal event occurrences per participant over the study period. KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Time frame: Up to approximately 4.5 years
Percentage of participants with post-baseline Best corrected visual acuity of 20/50, 20/100, 20/200
Best corrected visual acuity test results are expressed as a fraction, such as 20/50. The top number is the testing distance of 20 feet, and the bottom number is the distance at which a person with average vision could read the same line. 20/50 indicates mild visual impairment, 20/100 indicates moderate visual impairment and 20/200 indicates severe visual impairment.
Time frame: Up to approximately 4.5 years
Number of participants with ocular adverse events and adverse events of special interest by National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) Version 6.0
Time frame: Up to approximately 4.5 years
Number of participants with adverse events related dose modifications due to ocular toxicity by NCI-CTCAE Version 6.0
Time frame: Up to approximately 4.5 years
Number of participants with adverse events related dose modifications due to ocular toxicity by KVA scale
KVA scale ranges from 0 to 4 with higher scores indicating greater severity of corneal events.
Time frame: Up to approximately 4.5 years
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better as assessed by the investigator per International Myeloma Working Group (IMWG) criteria.
Time frame: Up to approximately 4.5 years
Percentage of participants with a confirmed Very good partial response (VGPR) or better
Time frame: Up to approximately 4.5 years
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate, defined as the percentage of participants who are MRD-negative by next-generation sequencing (NGS) at 10\^-5 sensitivity threshold during the time of confirmed complete response (CR) or better response as assessed by the investigator per IMWG criteria.
Time frame: Up to approximately 4.5 years
Progression-Free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of documented Progressive disease (PD) as assessed by the investigator per IMWG criteria or death due to any cause.
Time frame: Up to approximately 4.5 years
Number of participants with adverse events by NCI-CTCAE Version 6.0
Time frame: Up to approximately 4.5 years
Number of participants with clinically significant changes in hematology, chemistry, urinalysis parameters
Time frame: Up to approximately 4.5 years
Concentration at end of infusion (C-EOI) following administration of belantamab mafodotin
Time frame: Up to approximately 4.5 years
Area under the plasma concentration-time curve from time 0 to time t (AUC[0-t]) following administration of belantamab mafodotin
Time frame: Up to approximately 4.5 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of life questionnaire core 30 (EORTC QLQ-C30) score
The EORTC QLQ-C30 score ranges from 0 to 100 with higher score indicates better functioning or a better overall state of health.
Time frame: Baseline (Day 1) and up to approximately 4.5 years
Maximum Post-baseline Patient-reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials and is measured using a scale ranging from 0 to 100. Higher scores indicate poorer side effect experiences.
Time frame: Up to approximately 4.5 years
Mean change from Baseline in vision-related functioning as measured by ocular surface disease index (OSDI)
The OSDI scores range from 0 to 100. Higher score indicates greater symptom severity.
Time frame: Baseline (Day 1) and up to approximately 4.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.