| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 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. | DLT Evaluable population included participants fulfilling the 'All Treated' population (all eligible participants who received at least 1 dose of study treatment) criteria, and those who received a complete infusion in 21- day Cycle 1. | Posted | | Count of Participants | | Participants | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Part 2: Arm A: Number of Participants With DLTs | 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. | DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of bortezomib/dexamethasone in 21-day Cycle 1. | Posted | | Count of Participants | | Participants | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
|
| Primary | Part 2: Arm B: Number of Participants With DLTs | 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. | DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of pomalidomide/dexamethasone in 28-day Cycle 1. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Primary | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | All Treated Population included all eligible participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | | Posted | | Count of Participants | | Participants | | Up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) |
|
| Primary | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | 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. | All treated population. Only those participants with data available at specified category have been analyzed. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 |
|
| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | 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. | All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | |
|
| Primary | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters | 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. | All treated population. Only those participants with data available at specified category have been analyzed. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
|
| Primary | Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | 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. | All treated population. Only those participants with data available at specified category have been analyzed. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
|
| Primary | Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
|
| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | 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. | All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg |
|
| Primary | Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) |
|
| Primary | Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | 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. | All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
|
| Primary | Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | 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. | All treated population. Only those participants with data available at specified category have been analyzed. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein | 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. | All treated population. Only those participants with data available at specified category have been analyzed. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | |
|
| Primary | Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH) | 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. | All treated population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Change From Baseline in Urine Potential of Hydrogen (pH) | 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. | All treated population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Primary | Part 1: Change From Baseline in Urine Specific Gravity by Dipstick | 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. | All treated population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Change From Baseline in Urine Specific Gravity by Dipstick | 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. | All treated population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Primary | 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) | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
|
| Primary | 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) | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | |
|
| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Primary | Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Primary | Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
|
| Primary | Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF | 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. | All treated population. Only those participants with data available at specified time points have been analyzed. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 |
|
| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
|
| Secondary | 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)) | Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram/millilitre (h*ug/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | 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) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per hour (mL/h) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Median | Full Range | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/hour (h) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | hour (h) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram/millilitre (h*ug/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/h | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Median | Full Range | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | hour (h) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | hour (h) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 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. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | 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. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 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. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | 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. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | 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. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/h | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | hour (h) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ). | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ). | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. AUC(0-inf) were not calculated for some participants since there were no sufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Vss was not calculated for some participants as sufficient data was not available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | hour (h) | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nanogram (ng)/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram (pg)/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | Day | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. | Posted | | Median | Full Range | h | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
| |
| Secondary | Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF) | Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. | Pharmacokinetic population | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23 | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
| |
| Secondary | Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin. | | Posted | | Count of Participants | | Participants | | Up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin. | | Posted | | Count of Participants | | Participants | | Up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 1: Titers of ADAs Against Belantamab Mafodotin | 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. | All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected. | Posted | | | | | | Up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. |
| |
| Secondary | Part 2: Titers of ADAs Against Belantamab Mafodotin | 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. | All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected. | Posted | | | | | | Up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|
| Secondary | Part 1 - Percentage of Participants With Overall Response Rate (ORR) | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | |
|
| Secondary | Part 2 - Percentage of Participants With ORR | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) |
|
| Secondary | Part 1: Clinical Benefit Rate (CBR) | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 141 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. | | OG001 | Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg |
|
| Secondary | Part 2: Clinical Benefit Rate (CBR) | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. |
|
| Primary | Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status | 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. | | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and up to approximately 212 weeks | | | | ID | Title | Description |
|---|
| OG000 | Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter^2 (m^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles. | | OG001 | Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression. |
|