An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03828292
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Belantamab mafodotin Monotherapy Belantamab mafodotin - Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone Dexamethasone - Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone Pomalidomide - Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone Bortezomib - Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone Dexamethasone - Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone Belantamab mafodotin - Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone Belantamab mafodotin -
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) Up to Day 21 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\^3accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment for abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03.
Part 2: Arm A: Number of Participants With DLTs Up to Day 21 DLT is an 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 clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Part 2: Arm B: Number of Participants With DLTs Up to Day 28 DLT is an 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 clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to approximately 141 weeks An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. SAEs are subset of AEs.
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to approximately 212 weeks 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.
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters Baseline (Day 1) and up to approximately 141 weeks Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-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. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters Baseline (Day 1) and up to approximately 141 weeks Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. 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 v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters Baseline (Day 1) and up to approximately 212 weeks Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to NCI-CTCAE v 4.03. G1: 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. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters Baseline (Day 1) and up to approximately 212 weeks Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. 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 v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Baseline (Day 1) and up to approximately 141 weeks Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: 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. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Baseline (Day 1) and up to approximately 141 weeks Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), erythrocytes, Hematocrit, monocytes and reticulocytes. 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 have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters Baseline (Day 1) and up to approximately 212 weeks Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: 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. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters Baseline (Day 1) and up to approximately 212 weeks Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, MCHC, MCH, MCV, erythrocytes, Hematocrit, monocytes and reticulocytes. 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, changes to normal or no changes, and increases to high from baseline values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein Baseline (Day 1) and up to approximately 141 weeks 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, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein Baseline (Day 1) and up to approximately 212 weeks 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, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) Baseline (Day 1) and up to approximately 141 weeks Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) Baseline (Day 1) and up to approximately 212 weeks Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Change From Baseline in Urine Specific Gravity by Dipstick Baseline (Day 1) and up to approximately 141 weeks Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Change From Baseline in Urine Specific Gravity by Dipstick Baseline (Day 1) and up to approximately 212 weeks Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Baseline (Day 1) and up to approximately 141 weeks DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Baseline (Day 1) and up to approximately 212 weeks DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature Baseline (Day 1) and up to approximately 141 weeks Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature Baseline (Day 1) and up to approximately 212 weeks Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate Baseline (Day 1) and up to approximately 141 weeks Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate Baseline (Day 1) and up to approximately 212 weeks Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) Baseline (Day 1) and up to approximately 141 weeks 12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF Baseline (Day 1) and up to approximately 212 weeks 12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline (Day 1) and up to approximately 141 weeks The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status Baseline (Day 1) and up to approximately 212 weeks Any change in ECOG Performance status that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported.
- Secondary Outcome Measures
Name Time Method Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC)) Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B) Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin Up to approximately 141 weeks Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin Up to approximately 212 weeks Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Part 1: Titers of ADAs Against Belantamab Mafodotin Up to approximately 141 weeks Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Part 2: Titers of ADAs Against Belantamab Mafodotin Up to approximately 212 weeks Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Part 1 - Percentage of Participants With Overall Response Rate (ORR) Up to approximately 141 weeks ORR is 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 \[sCR\]) of best response, 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= 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 hour (h); PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h.
Part 2 - Percentage of Participants With ORR Up to approximately 212 weeks ORR is defined as the percentage of participants with a confirmed PR or better (i.e. PR, VGPR, CR, and sCR) of best response, according to the 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= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h.
Part 1: Clinical Benefit Rate (CBR) Up to approximately 141 weeks CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the 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= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Part 2: Clinical Benefit Rate (CBR) Up to approximately 212 weeks CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the 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= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Trial Locations
- Locations (1)
GSK Investigational Site
🇯🇵Tokyo, Japan