Sub-study of Belantamab Mafodotin (GSK2857916) in Combina... | NCT07150091

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

Label	Type	Description	Intervention Names
Belantamab mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Experimental		Drug: Belantamab mafodotin Drug: Nirogacestat Drug: Lenalidomide Drug: Dexamethasone

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

Measure	Description	Time Frame
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 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 143 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 the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. 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 increase 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.	Baseline (Day 1) and up to 143 weeks
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline

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		Boston	Massachusetts	02215	United States
GSK Investigational Site

ID	Title	Description
FG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 6, 2026

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Anticipated Posting Date

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Primary

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 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	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Units	Counts
Participants	OG0005 OG0015

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	OG0001 OG0012

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. 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 increase 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001

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 chemistry parameters. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; 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 increase 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. CPK = creatine kinase. GGT = gamma glutamyl transferase.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Primary

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

DE Phase: Overall Response Rate (ORR)

Safety population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

CE Phase: Clinical Benefit Rate (CBR)

Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as >= 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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] as 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

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

Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] as assessed by the investigator per IMWG (2016). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

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

Posted

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

DE Phase: Plasma Concentrations 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 analyzed. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Posted

Median

Full Range

Nanogram/ millilitre (ng/mL)

Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1; anytime samples at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and end of treatment (~143 weeks)

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

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

Blood samples were 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 or available for analysis at that particular time point for the respective Arms/Groups.

Posted

Median

Full Range

Nanogram/ millilitre (ng/mL)

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody

Blood samples were 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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

Median

Full Range

Picogram / millilitre (pg/mL)

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

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

Blood samples were 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin

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

Posted

Median

Full Range

ng/mL

Predose, 30 minutes, 1, 2, and 4 hours postdose on Cycle(C)1 Day -2; Predose on Day 1, 4, and 8 of C1; Predose, 30 minutes, 1, 2, and 4 hours postdose on C2 Day 1

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

Secondary

CE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin

Blood samples were to be collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.

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

Posted

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

DE Phase: Titer of ADAs Against Belantamab Mafodotin

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

Posted

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

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

Safety population

Posted

Count of Participants

Participants

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

Secondary

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

The corneal events were to be 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 were to be presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.

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

Posted

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001

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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

Secondary

CE Phase: Number of Participants With 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 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.

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: 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

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

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

Up to 143 weeks

ID	Title	Description
OG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
OG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG0008 events3 affected10 at risk EG0015 events3 affected10 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG00011 events1 affected10 at risk EG0010 events0 affected10 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG00018 events4 affected10 at risk EG0011 events1 affected10 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG00017 events4 affected10 at risk EG0013 events3 affected10 at risk
Pericardial effusion	Cardiac disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Sinus bradycardia	Cardiac disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected10 at risk
Sinus tachycardia	Cardiac disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Cataract	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Cataract subcapsular	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Diplopia	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected10 at risk
Dry eye	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0013 events3 affected10 at risk
Eye irritation	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0013 events3 affected10 at risk
Eye pain	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected10 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0013 events3 affected10 at risk
Glaucoma	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Keratitis	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Photophobia	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events2 affected10 at risk
Retinopathy	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Vision blurred	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0003 events1 affected10 at risk EG0014 events4 affected10 at risk
Visual acuity reduced	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0003 events1 affected10 at risk EG0013 events1 affected10 at risk
Visual impairment	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Vitreous detachment	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Vitreous floaters	Eye disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0012 events2 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG00015 events6 affected10 at risk EG0015 events2 affected10 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0004 events2 affected10 at risk EG0016 events5 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0004 events2 affected10 at risk EG0012 events2 affected10 at risk
Asthenia	General disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Chills	General disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Drug intolerance	General disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Face oedema	General disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Fatigue	General disorders	MedDRA v28.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0014 events4 affected10 at risk
Generalised oedema	General disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected10 at risk
Influenza like illness	General disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Oedema peripheral	General disorders	MedDRA v28.1	Systematic Assessment	EG0004 events1 affected10 at risk EG0012 events2 affected10 at risk
Pyrexia	General disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected10 at risk
COVID-19	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Cystitis	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected10 at risk
Fungal skin infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Herpes zoster	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Hordeolum	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Influenza	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0004 events1 affected10 at risk EG0010 events0 affected10 at risk
Norovirus infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Oral candidiasis	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Respiratory tract infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected10 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events1 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected10 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Alanine aminotransferase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0009 events1 affected10 at risk EG0018 events2 affected10 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0005 events1 affected10 at risk EG0014 events2 affected10 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Blood chloride increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0006 events1 affected10 at risk EG0010 events0 affected10 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0007 events1 affected10 at risk EG0010 events0 affected10 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0003 events1 affected10 at risk EG0014 events2 affected10 at risk
Blood phosphorus increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
C-reactive protein increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0003 events1 affected10 at risk EG0011 events1 affected10 at risk
Glomerular filtration rate decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Lymphocyte count decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected10 at risk
Neutrophil count decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG00111 events4 affected10 at risk
Platelet count decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG00112 events6 affected10 at risk
Weight decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
White blood cell count decreased	Investigations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0014 events2 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0013 events2 affected10 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected10 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0004 events2 affected10 at risk EG0018 events6 affected10 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected10 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v28.1	Systematic Assessment	EG0003 events2 affected10 at risk EG00112 events6 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0003 events2 affected10 at risk EG0012 events2 affected10 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected10 at risk
Brain fog	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected10 at risk
Cognitive disorder	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Dizziness	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected10 at risk
Headache	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Paraesthesia	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Presyncope	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Syncope	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Insomnia	Psychiatric disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected10 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Proteinuria	Renal and urinary disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v28.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0013 events3 affected10 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0012 events2 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected10 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events2 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected10 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected10 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected10 at risk
Hypertension	Vascular disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0015 events2 affected10 at risk
Hypotension	Vascular disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 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	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
BG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
BG002	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	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.	4	10	5	10	8	10
EG001	1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.0 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution infused over 30- 60 minutes Q4W for cycle 1 and then Q8W for cycle 2 onwards on day 1 of 28-day cycle in Q4W and 56-day cycle in Q8W in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28; with Lenalidomide 25 mg (10 mg if Estimated Glomerular Filtration (eGFR) is 40-60 milliLitre (mL)/minute/1.73 square meter (m)^2) administered orally once daily (QD) from Day 1 to Day 21; and Dexamethasone 40 mg (20 mg for participants >75 years old or BMI <18.5 kg/m^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.	3	10	8	10	10	10

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Cardiac amyloidosis	Cardiac disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Cardiac failure	Cardiac disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events2 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected10 at risk
Asthenia	General disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected10 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected10 at risk
Dengue fever	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
Febrile infection	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Pneumonia	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0003 events3 affected10 at risk EG0011 events1 affected10 at risk
Pneumonia legionella	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Sepsis	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Septic shock	Infections and infestations	MedDRA v28.1	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected10 at risk
C-reactive protein increased	Investigations	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA v28.1	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected10 at risk

ID	Term
C000631691	belantamab mafodotin
C550722	nirogacestat
D000077269	Lenalidomide
D003907	Dexamethasone