This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
325
Belantamab mafodotin will be administered.
Pomalidomide and Dexamethasone will be administered.
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Pueblo, Colorado, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Clifton Park, New York, United States
Progression-free Survival (PFS) Based on Investigator-assessed Response as Per International Myeloma Working Group (IMWG)
PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter \[g/dL\]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured \>1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
Time frame: Up to 27 months
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: 60 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG.
Time frame: Up to 55 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG.
Time frame: Up to 55 months
Duration of Response (DoR)
DoR is defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better.
Time frame: Up to 55 months
Time to Response (TTR)
TTR is defined as the 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 frame: Up to 55 months
Time to Progression (TTP)
TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.
Time frame: Up to 55 months
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time frame: Up to 55 months
Change From Baseline in Hematology Parameters: Absolute White Blood Cell Count (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, and Neutrophils (Giga Cells Per Liter)
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count and Reticulocyte Count (Trillion Cells Per Liter)
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Grams Per Liter)
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Hematology Parameters: Hematocrit (Proportion of Red Blood Cells in Blood)
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Hematology Parameters: Mean Corpuscular Volume (MCV) [Femtoliter]
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms]
Blood samples will be collected for the analysis of hematology parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)
Blood samples will be collected for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH \[International units per Liter
Time frame: Baseline and up to 55 months
Change From Baseline in Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Magnesium, Blood Urea Nitrogen (BUN), and Phosphorous (Millimoles Per Liter)
Blood samples will be collected for the analysis of clinical chemistry parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin, Uric Acid (Micromoles Per Liter)
Blood samples will be collected for the analysis of clinical chemistry parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein (Grams Per Liter)
Blood samples will be collected for the analysis of clinical chemistry parameters.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Specific Gravity (Ratio)
Urine samples will be collected for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameters- Urine Potential of Hydrogen (pH) (Points on a Scale)
Urine samples will be collected for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Glucose (Millimole Per Liter)
Urine samples will be collected for the assessment of urinary glucose.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Protein (Grams Per Liter)
Urine samples will be collected for the assessment of urinary protein.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Ketones (Millimoles Per Liter)
Urine samples will be collected for the assessment of urinary ketones.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Blood (10^9 Cells Per Liter)
Urine samples will be collected for the assessment of urinary blood.
Time frame: Baseline and up to 55 months
Change From Baseline in Urinalysis Parameter: Creatinine/Albumin Ratio (Ratio)
Urine samples will be collected for the assessment of urinary creatinine/albumin ratio.
Time frame: Baseline and up to 55 months
Number of Participants With Abnormal Ocular Findings
Participants will be assessed for any abnormal ocular findings.
Time frame: Up to 55 months
Plasma Concentrations of Belantamab Mafodotin
Blood samples will be collected for the analysis.
Time frame: Up to 55 months
Plasma Concentrations of Total Monoclonal Antibody (mAb)
Blood samples will be collected for the analysis.
Time frame: Up to 55 months
Plasma Concentrations of Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF)
Blood samples will be collected for the analysis.
Time frame: Up to 55 months
Number of Participants With Anti-drug Antibody (ADAs) Against Belantamab Mafodotin
Blood samples will be collected for the analysis.
Time frame: Up to 55 months
Titer of ADAs Against Belantamab Mafodotin
Blood samples will be collected for the analysis.
Time frame: Up to 55 months
Number of Participants With Symptomatic Adverse Effects Measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Time frame: Up to 55 months
Number of Participants With Symptomatic Adverse Effects Measured by Ocular Surface Disease Index (OSDI)
OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. A higher score represents greater symptoms severity.
Time frame: Up to 55 months
European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) Score
The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning.
Time frame: Up to 55 months
Rate of Minimal Residual Disease (MRD)
MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method.
Time frame: Up to 55 months
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