Sub-study of Belantamab Mafodotin (GSK2857916) in Combina... | NCT07217119

ID	Type	Description	Link
2023-509550-55-00	EU Trial (CTIS) Number

Label	Type	Description	Intervention Names
Belantamab mafodotin + Feladilimab	Experimental		Drug: Belantamab mafodotin Drug: Feladilimab

Name	Type	Description	Arm Group Labels	Other Names
Belantamab mafodotin	Drug	Belantamab mafodotin will be administered.	Belantamab mafodotin + Feladilimab

Measure	Description	Time Frame
Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLTs)	Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.	Up to 28 days
DE Phase: Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.	Up to approximately 281 weeks
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline	Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.

Measure	Description	Time Frame
DE Phase: Overall Response Rate (ORR)	Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as 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. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Atlanta	Georgia	30322	United States
GSK Investigational Site

ID	Title	Description
FG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 3, 2024	Apr 16, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLTs)

Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

DLT Evaluable Population included participants in DE Phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.

Posted

Count of Participants

Participants

Up to 28 days

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Units	Counts
Participants	OG0009 OG00110 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011 OG0020

Primary

DE Phase: Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety population included all participants who received at least one dose of any component of the combination therapy.

Posted

Count of Participants

Participants

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Primary

DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline

Blood samples were collected for evaluation of hematology parameters including Anemia, Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.

Safety population

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Primary

DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline

Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia (HypoG), hypoalbuminemia (HypoA), creatine kinase increased (CPKI), hyperkalemia, blood lactate dehydrogenase increased (LDHI), hypermagnesemia (HyperM), hypomagnesemia (HypoM), hypernatremia (HyperN), hypercalcemia (HyperC), hypocalcemia (HypoC) and chronic kidney disease (CKD). ). The laboratory parameters were graded according to CTCAE v 5.0. G1: mild; G2: moderate; G3: severe; G4: life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. The laboratory parameters were graded according to CTCAE v 5.0.

Safety population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).

Primary

Cohort Expansion (CE) Phase: Overall Response Rate (ORR)

Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as 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. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Secondary

DE Phase: Overall Response Rate (ORR)

Safety population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Secondary

CE Phase: Clinical Benefit Rate (CBR)

Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)

Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR defined as 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. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Safety population

Posted

Number

Percentage of Participants

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Secondary

CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Plasma Concentration of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. The "0" participants analyzed represents that data was not collected for analysis at that particular time point for the respective Arms/Groups.

Posted

Mean

Standard Deviation

Nanogram/ millilitre (ng/mL)

Predose, end of infusion (EOI), 2 and 24 hours postdose on Cycle (C) 1 Day (D) 1; anytime sample at C1 D4 and D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at end of treatment (EoT, up to approximately 281 weeks.)

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Secondary

CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.

PK population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected for analysis at that particular time point for the respective Arms/Groups.

Posted

Mean

Standard Deviation

Nanogram/ millilitre (ng/mL)

Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks.)

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody

Blood samples were planned to be collected for PK analysis of Belantamab mafodotin plasma total antibody.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).

Posted

Mean

Standard Deviation

Picogram / millilitre (pg/mL)

Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks)

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

Blood samples were planned to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Feladilimab Concentration When Administered in Combination With Belantamab Mafodotin

Blood samples were collected for PK analysis of Feladilimab when administered intravenously in combination with belantamab mafodotin.

Posted

Mean

Standard Deviation

ng/mL

Predose, EOI, 2 and 24 hours postdose on C1 D1, anytime sample at C1 D4, D8; Predose and EOI on D1 of C2, C4, C6, C9, C12; Predose on C18 D1; and at EoT (up to approximately 281 weeks)

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Feladilimab Concentration When Administered in Combination With Belantamab Mafodotin

Blood samples were planned to be collected for PK analysis Feladilimab when administered intravenously in combination with belantamab mafodotin.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.

Safety population.

Posted

Count of Participants

Participants

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin

Serum samples were to be 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.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Titer of ADAs Against Belantamab Mafodotin

Safety population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.

Posted

Median

Full Range

Titer

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Titer of ADAs Against Belantamab Mafodotin

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Number of Participants With Post-baseline Positive ADAs Against Feladilimab

Serum samples were 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.

Safety population.

Posted

Count of Participants

Participants

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With Post-baseline Positive ADAs Against Feladilimab

Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Titre of ADAs Against Feladilimab

Safety population. No participants were found positive for ADAs, hence participants were not analyzed for titer of ADAs.

Posted

Up to approximately 281 weeks

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Titer of ADAs Against Feladilimab

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)

Safety population

Posted

Count of Participants

Participants

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With AESI

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade

The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.

Safety population.

Posted

Count of Participants

Participants

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Secondary

CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Secondary

CE Phase: Progression-free Survival (PFS)

PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Duration of Response (DoR)

DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Time to Response (TTR)

TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Overall Survival (OS)

OS is defined as the time from randomization until death due to any cause.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With AEs and SAEs

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With AEs Leading to Discontinuation

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With AEs Leading to Dose Reduction or Delay

Number of participants with dose reduction or delay were to be evaluated.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

Secondary

CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters

Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant; Grade 4 (G4): Life-threatening consequences; Grade 5 (G5): Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Baseline (Day 1) and up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Secondary

CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters

Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: severe or medically significant; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Posted

Baseline (Day 1) and up to approximately 281 weeks.

ID	Title	Description
OG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
OG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
OG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0004 events4 affected9 at risk EG0018 events6 affected10 at risk EG0022 events2 affected6 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0017 events5 affected10 at risk EG0023 events2 affected6 at risk
Atrial flutter	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Bradycardia	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Sinus bradycardia	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Sinus tachycardia	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Tachycardia	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Deafness	Ear and labyrinth disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Hypothyroidism	Endocrine disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Asthenopia	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Cataract	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0023 events3 affected6 at risk
Corneal cyst	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Corneal epithelial microcysts	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0007 events2 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Corneal opacity	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Corneal toxicity	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Dry eye	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected9 at risk EG0015 events3 affected10 at risk EG0028 events4 affected6 at risk
Eye irritation	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0029 events2 affected6 at risk
Eye pain	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0022 events2 affected6 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected9 at risk EG0012 events1 affected10 at risk EG0023 events1 affected6 at risk
Glaucoma	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0020 events0 affected6 at risk
Keratopathy	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0008 events4 affected9 at risk EG0017 events7 affected10 at risk EG0026 events3 affected6 at risk
Photophobia	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0003 events2 affected9 at risk EG0013 events3 affected10 at risk EG00212 events4 affected6 at risk
Retinal haemorrhage	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Vision blurred	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0007 events4 affected9 at risk EG0016 events6 affected10 at risk EG00211 events4 affected6 at risk
Visual acuity reduced	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Visual impairment	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0010 events0 affected10 at risk EG0023 events2 affected6 at risk
Vitreous floaters	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Vitreous haemorrhage	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Xerophthalmia	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0022 events1 affected6 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0020 events0 affected6 at risk
Constipation	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events2 affected10 at risk EG0021 events1 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0013 events2 affected10 at risk EG0022 events2 affected6 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Enteritis	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Gastritis	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Nausea	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0015 events3 affected10 at risk EG0021 events1 affected6 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Toothache	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0022 events1 affected6 at risk
Vomiting	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Asthenia	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Catheter site haemorrhage	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Chest pain	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Chills	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0020 events0 affected6 at risk
Fatigue	General disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0013 events3 affected10 at risk EG0022 events2 affected6 at risk
Gait disturbance	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Malaise	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Non-cardiac chest pain	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Oedema peripheral	General disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Pain	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Pyrexia	General disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0013 events3 affected10 at risk EG0020 events0 affected6 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Bronchitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
COVID-19	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Furuncle	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Herpes zoster	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Nasopharyngitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Perichondritis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Pneumonia	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0020 events0 affected6 at risk
Rash pustular	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Rhinitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Sepsis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Skin infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0020 events0 affected6 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events2 affected10 at risk EG0021 events1 affected6 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0021 events1 affected6 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0004 events3 affected9 at risk EG0013 events2 affected10 at risk EG0021 events1 affected6 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Ocular procedural complication	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Alanine aminotransferase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0011 events1 affected10 at risk EG0029 events3 affected6 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0014 events3 affected10 at risk EG0022 events2 affected6 at risk
Blood creatinine increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0013 events2 affected10 at risk EG0020 events0 affected6 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Lymphocyte count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0014 events3 affected10 at risk EG0024 events1 affected6 at risk
Neutrophil count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0013 events3 affected10 at risk EG0021 events1 affected6 at risk
Platelet count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Weight decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events2 affected10 at risk EG0020 events0 affected6 at risk
White blood cell count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events2 affected10 at risk EG0021 events1 affected6 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0003 events2 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0020 events0 affected6 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0014 events3 affected10 at risk EG0020 events0 affected6 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0013 events3 affected10 at risk EG0020 events0 affected6 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0021 events1 affected6 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected9 at risk EG0014 events3 affected10 at risk EG0024 events3 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0022 events1 affected6 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0022 events2 affected6 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Amnesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Cognitive disorder	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0020 events0 affected6 at risk
Disturbance in attention	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Dizziness	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected9 at risk EG0012 events2 affected10 at risk EG0023 events2 affected6 at risk
Dizziness postural	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Dysarthria	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Facial paresis	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Headache	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0021 events1 affected6 at risk
Hemianopia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Hemiparesis	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0020 events0 affected6 at risk
Lethargy	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Memory impairment	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Somnolence	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Spinal cord compression	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Taste disorder	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Tremor	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Confusional state	Psychiatric disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Hallucination	Psychiatric disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Proteinuria	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Urinary retention	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events1 affected10 at risk EG0024 events2 affected6 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events1 affected10 at risk EG0021 events1 affected6 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0014 events2 affected10 at risk EG0020 events0 affected6 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events1 affected10 at risk EG0020 events0 affected6 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected10 at risk EG0022 events1 affected6 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0023 events2 affected6 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0022 events1 affected6 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected10 at risk EG0021 events1 affected6 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected10 at risk EG0020 events0 affected6 at risk
Haematoma	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Hypertension	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0015 events2 affected10 at risk EG0022 events1 affected6 at risk
Hypotension	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected10 at risk EG0020 events0 affected6 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected10 at risk EG0021 events1 affected6 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Title	Description
BG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
BG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
BG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).	7	9	3	9	9	9
EG001	2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.	6	10	6	10	9	10
EG002	2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab	Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.	2	6	1	6	6	6