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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03544281
Registration number
NCT03544281
Ethics application status
Date submitted
30/04/2018
Date registered
1/06/2018
Titles & IDs
Public title
To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
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Scientific title
A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6
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Secondary ID [1]
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2017-004689-93
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Secondary ID [2]
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207497
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Universal Trial Number (UTN)
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Trial acronym
DREAMM 6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Belantamab mafodotin
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Bortezomib
Experimental: Arm A: Belantamab mafodotin+lenalidomide +dexamethasone - Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion.
SPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle.
STRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \& 22 of each cycle.
Experimental: Arm B: Belantamab mafodotin+bortezomib+dexamethasone - Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \& so on). Bortezomib will be administered at 1.3 mg/m\^2 SC/IV on Days 1,4,8, \& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \& 12 of every 21-day cycle.
Treatment: Drugs: Belantamab mafodotin
Selected doses of belantamab mafodotin will be administered as an infusion.
Treatment: Drugs: Lenalidomide
Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.
Treatment: Drugs: Dexamethasone
Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.
Treatment: Drugs: Bortezomib
Bortezomib will be administered as 1.3 mg/m\^2, as SC or IV, with belantamab mafodotin and dexamethasone.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A
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Assessment method [1]
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DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Number of Participants With DLTs, Treatment B
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Assessment method [2]
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DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist \>48 h despite supportive treatment or abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment).
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Timepoint [2]
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Up to 21 days
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Primary outcome [3]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [3]
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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. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
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Timepoint [3]
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Up to approximately 4.5 years
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Primary outcome [4]
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Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
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Assessment method [4]
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12-lead electrocardiogram (ECGs) were obtained using an automated ECG machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and \>60 msec, and \>530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Data of number of participants with worst-case increase post baseline is presented.
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Timepoint [4]
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Up to approximately 4.5 years
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Primary outcome [5]
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Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
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Assessment method [5]
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Blood samples were collected for analysis of following hematology parameters: Hemoglobin (hemoglobin increased and anemia), Lymphocytes (lymphocyte count increased and lymphocyte count decreased), Neutrophils, Platelets and Leukocytes (leukocytosis and white blood cells decreased). The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
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Timepoint [5]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [6]
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Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
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Assessment method [6]
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Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, erythrocytes and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
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Timepoint [6]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [7]
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Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
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Assessment method [7]
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Blood samples were collected for analysis of following clinical chemistry parameters: Hyperglycemia, Hypoglycemia, Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase, (AST), Bilirubin, Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Hyperkalemia, Hypokalemia, Hypermagnesemia, Hypomagnesemia, Phosphate, Hypernatremia, Hyponatremia, Urate, Hypercalcemia and Hypocalcemia. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
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Timepoint [7]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [8]
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Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
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Assessment method [8]
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Blood samples were collected for analysis of following clinical chemistry parameters: Direct Bilirubin (DB), Calcium, Chloride, Carbon Dioxide (CO2), lactate dehydrogenase (LDH) and Protein. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
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Timepoint [8]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [9]
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Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein
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Assessment method [9]
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Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, \>3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
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Timepoint [9]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [10]
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Change From Baseline in Urine Potential of Hydrogen (pH)
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Assessment method [10]
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Urine samples were collected to analyze urine pH levels. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
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Timepoint [10]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [11]
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Change From Baseline in Urine Specific Gravity
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Assessment method [11]
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Urine samples were collected to analyze urine specific gravity using dipstick method. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.
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Timepoint [11]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [12]
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Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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Assessment method [12]
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Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
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Timepoint [12]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [13]
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Change From Baseline in Vital Signs : Pulse Rate
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Assessment method [13]
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Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
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Timepoint [13]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [14]
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Change From Baseline in Vital Signs : Temperature
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Assessment method [14]
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Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
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Timepoint [14]
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Baseline (Day 1) and up to approximately 4.5 years
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Primary outcome [15]
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Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)
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Assessment method [15]
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ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasmacytomas in the bone marrow; sCR: stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR: \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. Confidence intervals were based on the exact method.
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Timepoint [15]
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Up to approximately 4.5 years
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Secondary outcome [1]
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Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC), Treatment A
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Assessment method [1]
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Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [1]
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Pre-Dose, 0, 2 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [2]
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Area Under the Concentration Time Curve (AUC) From Time 0 to 504 Hours (0-504h) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [2]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [2]
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Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
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Secondary outcome [3]
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AUC (0-672h) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [3]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [3]
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Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
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Secondary outcome [4]
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Time to Reach Maximum Observed Concentration (Tmax) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [4]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [4]
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0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [5]
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Time of Last Observed Quantifiable Concentration (Tlast) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [5]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
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Timepoint [5]
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Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28
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Secondary outcome [6]
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Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [6]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [6]
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0
Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
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Secondary outcome [7]
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Observed Plasma Concentration at the End of Infusion (C-EOI) for Belantamab Mafodotin ADC, Treatment A
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Assessment method [7]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [7]
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Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
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Secondary outcome [8]
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Cmax for Belantamab Mafodotin ADC, Treatment B
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Assessment method [8]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [8]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [9]
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0
AUC (0-504h) for Belantamab Mafodotin ADC, Treatment B
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Assessment method [9]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [9]
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0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
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Secondary outcome [10]
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0
AUC (0-1008h) for Belantamab Mafodotin ADC, Treatment B
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Assessment method [10]
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Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.
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Timepoint [10]
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0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7
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Secondary outcome [11]
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0
Tmax for Belantamab Mafodotin ADC, Treatment B
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Assessment method [11]
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0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [11]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [12]
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0
Tlast for Belantamab Mafodotin ADC, Treatment B
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Assessment method [12]
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0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
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Timepoint [12]
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0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 5 Day 1
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Secondary outcome [13]
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0
Ctrough for Belantamab Mafodotin ADC, Treatment B
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Assessment method [13]
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0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [13]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
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Secondary outcome [14]
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0
C-EOI for Belantamab Mafodotin ADC, Treatment B
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Assessment method [14]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [14]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8
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Secondary outcome [15]
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0
Cmax for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [15]
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0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [15]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [16]
0
0
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [16]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [16]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
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Secondary outcome [17]
0
0
AUC (0-672h) for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [17]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [17]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
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Secondary outcome [18]
0
0
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [18]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
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Timepoint [18]
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0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7
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Secondary outcome [19]
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0
AUC(0-1344h) for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [19]
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0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1344) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
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Timepoint [19]
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0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7
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Secondary outcome [20]
0
0
Tmax for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [20]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [20]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
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Secondary outcome [21]
0
0
Tlast for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [21]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
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Timepoint [21]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8
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Secondary outcome [22]
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0
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment A
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Assessment method [22]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
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Timepoint [22]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [23]
0
0
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment A
Query!
Assessment method [23]
0
0
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [23]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [24]
0
0
Cmax for Belantamab Mafodotin (Total Antibody) Treatment B
Query!
Assessment method [24]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [24]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [25]
0
0
AUC (0-504h) for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [25]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [25]
0
0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
Query!
Secondary outcome [26]
0
0
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [26]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008h) was derived only for Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex, Belantamab mafodotin 2.5 mg/kg StepDown STRETCH + Bor/Dex and Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex cohorts.
Query!
Timepoint [26]
0
0
Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7
Query!
Secondary outcome [27]
0
0
Tmax for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [27]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [27]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [28]
0
0
Tlast for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [28]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Query!
Timepoint [28]
0
0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 9 Day 1
Query!
Secondary outcome [29]
0
0
Ctrough for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [29]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [29]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [30]
0
0
C-EOI for Belantamab Mafodotin (Total Antibody), Treatment B
Query!
Assessment method [30]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [30]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [31]
0
0
Cmax for Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A
Query!
Assessment method [31]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [31]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [32]
0
0
AUC (0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Query!
Assessment method [32]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [32]
0
0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, and Cycle 1 Day 8
Query!
Secondary outcome [33]
0
0
AUC (0-336h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Query!
Assessment method [33]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC (0-336h) was derived only for the Belantamab mafodotin 2.5mg/kg + Len/Dex SPLIT cohort.
Query!
Timepoint [33]
0
0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14
Query!
Secondary outcome [34]
0
0
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Query!
Assessment method [34]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [34]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [35]
0
0
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Query!
Assessment method [35]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [35]
0
0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 1 Day 15
Query!
Secondary outcome [36]
0
0
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment A
Query!
Assessment method [36]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [36]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [37]
0
0
Cmax for Belantamab Mafodotin (Cys-mcMMAF) Treatment B
Query!
Assessment method [37]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [37]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [38]
0
0
AUC(0-168h) for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Query!
Assessment method [38]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [38]
0
0
Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7
Query!
Secondary outcome [39]
0
0
Tmax for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Query!
Assessment method [39]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [39]
0
0
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8
Query!
Secondary outcome [40]
0
0
Tlast for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Query!
Assessment method [40]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Query!
Timepoint [40]
0
0
Pre-Dose Cycle 1 Day 1 to pre-dose Cycle 2 Day 1
Query!
Secondary outcome [41]
0
0
C-EOI for Belantamab Mafodotin (Cys-mcMMAF), Treatment B
Query!
Assessment method [41]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [41]
0
0
Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8
Query!
Secondary outcome [42]
0
0
Cmax for Lenalidomide (25 mg), Treatment A
Query!
Assessment method [42]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [42]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [43]
0
0
AUC(0-24h) for Lenalidomide (25 mg), Treatment A
Query!
Assessment method [43]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [43]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [44]
0
0
AUC (0-4h) for Lenalidomide (25 mg), Treatment A
Query!
Assessment method [44]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [44]
0
0
Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [45]
0
0
Tmax for Lenalidomide (25 mg), Treatment A
Query!
Assessment method [45]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [45]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [46]
0
0
Tlast for Lenalidomide (25 mg), Treatment A
Query!
Assessment method [46]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [46]
0
0
Pre-Dose, Post dose on Cycle 1 Day 1
Query!
Secondary outcome [47]
0
0
Cmax for Lenalidomide (10 mg), Treatment A
Query!
Assessment method [47]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [47]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [48]
0
0
AUC(0-24h) for Lenalidomide (10 mg), Treatment A
Query!
Assessment method [48]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [48]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [49]
0
0
AUC (0-4h) for Lenalidomide (10 mg), Treatment A
Query!
Assessment method [49]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [49]
0
0
Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [50]
0
0
Tmax for Lenalidomide (10 mg), Treatment A
Query!
Assessment method [50]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [50]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
Query!
Secondary outcome [51]
0
0
Tlast for Lenalidomide (10 mg), Treatment A
Query!
Assessment method [51]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [51]
0
0
Pre-Dose, Post dose on Cycle 1 Day 1
Query!
Secondary outcome [52]
0
0
Cmax for Bortezomib, Treatment B
Query!
Assessment method [52]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [52]
0
0
Pre-Dose, 0.5, 1, 2, 4 and 24 Hours Post-Dose on Cycle 1 Day 1
Query!
Secondary outcome [53]
0
0
AUC (0-72h) for Bortezomib, Treatment B
Query!
Assessment method [53]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [53]
0
0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Query!
Secondary outcome [54]
0
0
AUC (0-t) for Bortezomib, Treatment B
Query!
Assessment method [54]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [54]
0
0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Query!
Secondary outcome [55]
0
0
Tmax for Bortezomib, Treatment B
Query!
Assessment method [55]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [55]
0
0
Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
Query!
Secondary outcome [56]
0
0
Tlast for Bortezomib, Treatment B
Query!
Assessment method [56]
0
0
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Query!
Timepoint [56]
0
0
Pre-Dose, Post dose on Cycle 1 Day 3
Query!
Secondary outcome [57]
0
0
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Query!
Assessment method [57]
0
0
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays.
Query!
Timepoint [57]
0
0
Up to approximately 4.5 years (End of Treatment [EoT])
Query!
Secondary outcome [58]
0
0
Titers of ADAs Against Belantamab Mafodotin
Query!
Assessment method [58]
0
0
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin using validated immunoassays. Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titers of anti-drug antibodies against belantamab mafodotin is presented.
Query!
Timepoint [58]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [59]
0
0
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Scores
Query!
Assessment method [59]
0
0
The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). Higher scores indicated greater disability. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [59]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [60]
0
0
Change From Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores
Query!
Assessment method [60]
0
0
The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [60]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [61]
0
0
Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Query!
Assessment method [61]
0
0
The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE like Anxious, Blurred Vision, Chills, Concentration, Constipation, Cough, Decreased Appetite, Discouraged, Dizziness, Fatigue, Heart Palpitations, Insomnia, Memory, Mouth/Throat Sores, Nausea, Nosebleed, Numbness \& Tingling, Pain, Ringing In Ears, Shortness Of Breath, Vomiting and Watery Eyes. Number of participants with symptomatic AEs measured by PRO-CTCAEs are presented.
Query!
Timepoint [61]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [62]
0
0
Number of Participants With AEs of Special Interest (AESI)
Query!
Assessment method [62]
0
0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI for belantamab mafodotin (corneal events, thrombocytopenia and infusion related reactions) are presented.
Query!
Timepoint [62]
0
0
Up to approximately 4.5 years
Query!
Secondary outcome [63]
0
0
Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Query!
Assessment method [63]
0
0
BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline \<0.12 logMAR score; a possible worsened vision was defined as a change from baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from baseline \>=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [63]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [64]
0
0
Number of Participants With Worst-case Post-baseline Change in BCVA Scores by Snellen Results
Query!
Assessment method [64]
0
0
BCVA score was assessed individually for better seeing eye and worse seeing eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change post baseline categories are presented for better seeing eye and worse seeing eye. BCVA test scores by Snellen results were categorized as improved BCVA, \<= 2 lines decline in visual acuity from baseline, \>= 3 lines decline in visual acuity from baseline. Number of lines change from baseline was defined as the following: Improved BCVA equates to a negative change in logMAR from baseline BCVA. \<= 2 lines decline in visual acuity equates to logMAR change from baseline =0.37. \>= 3 lines decline in visual acuity equates to logMAR change from baseline =0.38. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [64]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [65]
0
0
Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Query!
Assessment method [65]
0
0
Number of participants with a Decline in BCVA to 'Light Perception (LP)' or 'No Light Perception (NLP)' due to a Corneal Event Anytime Post-Baseline are presented. BCVA score was assessed individually for each eye (Left and Right). Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Number of participants analyzed were who have any post-baseline BCVA score, where the Visual Acuity is due to corneal findings.
Query!
Timepoint [65]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [66]
0
0
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
Query!
Assessment method [66]
0
0
Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial haze were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented.
Query!
Timepoint [66]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [67]
0
0
Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings
Query!
Assessment method [67]
0
0
Participants with worse grade punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Query!
Timepoint [67]
0
0
Baseline (Day 1) and up to approximately 4.5 years
Query!
Secondary outcome [68]
0
0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score
Query!
Assessment method [68]
0
0
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [68]
0
0
Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])
Query!
Secondary outcome [69]
0
0
Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Query!
Assessment method [69]
0
0
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Query!
Timepoint [69]
0
0
Baseline (Day 1) and up to approximately 4.5 years (End of treatment [EoT])
Query!
Eligibility
Key inclusion criteria
* Capable of giving signed informed consent.
* Male or female, 18 years or older (at the time consent is obtained).
* Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
* Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
* Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy.
* Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
* Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
* All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be Grade <= 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
* Adequate organ system functions as defined by the laboratory assessments.
* The contraceptions used by female participants be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of belantamab mafodotin and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
WOCBP Participants Assigned to Arm A:
* Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective; beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1% per year) for a further 3 months, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period: Two negative pregnancy tests must be obtained prior to initiating lenalidomide therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing lenalidomide therapy.
WOCBP Participants Assigned to Arm B
* WOCBP assigned to Arm B must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on C1D1 and agree to use effective contraception during the study and for 4 months after the last dose of belantamab mafodotin or 7 months from the last dose of bortezomib, whichever is longer.
* Male participants using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Male participants are eligible to participate if they agree to the following:
Arm A: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin 4 weeks after the last dose of lenalidomide, whichever is longer, to allow for clearance of any altered sperm.
Arm B: from the time of first dose of study until 6 months after the last dose of belantamab mafodotin or 4 months from the last dose of bortezomib (whichever is the longer) to allow for clearance of any altered sperm.
* Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below.
* Agree to use a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse. Male participants should also use a condom with pregnant females. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Systemic anti-myeloma therapy (including systemic steroids) within <=14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
* Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
* Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
* Prior allogenic stem cell transplant. Note: Participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD).
* Evidence of active mucosal or internal bleeding.
* Any major surgery within the last four weeks.
* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
* Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
* Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
* Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
* Pregnant or lactating female.
* Active infection requiring treatment.
* Known Human immunodeficiency virus (HIV) infection.
* Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
* Current corneal disease except for mild punctuate keratopathy.
* Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at Screening or within 3 months prior to first dose of study treatment.
* Current corneal disease except for mild punctute keratopathy.
* Participants Assigned to Treatment A (belantamab mafodotin plus Len/Dex): Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
* Participants Assigned to Treatment B (belantamab mafodotin plus Bor/Dex): Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/09/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/02/2024
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Sample size
Target
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Accrual to date
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Final
153
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
0
0
GSK Investigational Site - Wollongong
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GSK Investigational Site - Woodville
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GSK Investigational Site - Fitzroy
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GSK Investigational Site - Melbourne
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Recruitment hospital [5]
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GSK Investigational Site - Murdoch
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2500 - Wollongong
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5011 - Woodville
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3065 - Fitzroy
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3000 - Melbourne
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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0
0
United States of America
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Alabama
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0
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Arizona
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0
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United States of America
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0
0
Georgia
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0
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United States of America
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0
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Indiana
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0
0
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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0
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0
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South Carolina
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0
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United States of America
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0
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Texas
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0
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Canada
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0
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Quebec
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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United Kingdom
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Cornwall
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Iqvia Pty Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone \[Len/Dex (Treatment A)\] or Bortezomib Plus Dexamethasone \[Bor/Dex (Treatment B)\] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
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Trial website
https://clinicaltrials.gov/study/NCT03544281
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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0
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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Available to whom?
Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/81/NCT03544281/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT03544281/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03544281