Trial Outcomes & Findings for Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM (NCT NCT06160609)

Last Updated: 2024-03-12

Results Overview

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 DLTs.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2024-03-12

Participant Flow

This is a sub-study of the master study NCT04126200. This sub study was terminated due to lack of efficacy. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants were enrolled in CE phase as study was early terminated.

Participant milestones

Participant milestones
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
Overall Study STARTED	6	3
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.	Total n=9 Participants Total of all reporting groups
Age, Continuous	69.0 Years STANDARD_DEVIATION 11.15 • n=5 Participants	73.3 Years STANDARD_DEVIATION 2.31 • n=7 Participants	70.4 Years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: DLT Evaluable Population included participants in DE phase who received the first course of treatment containing both agents within a sub-study and followed up within cycle 1 (Each cycle is of 21 days) or withdrew within cycle 1 due to an AE meeting the definition of a DLT.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Adverse Events (AEs)	6 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

Blood samples were collected for the analysis of following hematology parameters: eosinophils, anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, leukocytosis and white blood cell decreased. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant. 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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White Blood Cell Decreased, Increase to G1	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Eosinophils, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Eosinophils, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Eosinophils, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to G1	0 Participants	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to G2	2 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin Increased, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin Increased, Increase to G2	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Decreased, Increase to G1	1 Participants	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Decreased, Increase to G2	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Decreased, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Increased, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Increased, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte Count Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil Count Decreased, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil Count Decreased, Increase to G2	2 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil Count Decreased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet Count Decreased, Increase to G1	2 Participants	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet Count Decreased, Increase to G2	2 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet Count Decreased, Increase to G3	2 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White Blood Cell Decreased, Increase to G2	3 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White Blood Cell Decreased, Increase to G3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and Serum OR Plasma Glomerular Filtration Rate (GFR) from creatinine adjusted for body surface area (BSA) SA (mL/sec/1.73m\^2)/chronic kidney disease. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. 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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GFR from creatinine/Chronic Kidney Disease, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GFR from creatinine/Chronic Kidney Disease, Increase to G2	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GFR from creatinine/Chronic Kidney Disease, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to G3	0 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to G1	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to G2	2 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALP Increased, Increase to G1	4 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALP Increased, Increase to G2	0 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALP Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALT Increased, Increase to G1	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALT Increased, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline ALT Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline AST Increase, Increase to G1	4 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline AST Increase, Increase to G2	0 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline AST Increase, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood bilirubin Increased, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood bilirubin Increased, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood bilirubin Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK Increased, Increase to G1	2 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK Increased, Increase to G2	0 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Creatinine Increased, Increase to G1	3 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Creatinine Increased, Increase to G2	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Creatinine Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GGT Increased, Increase to G1	3 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GGT Increased, Increase to G2	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline GGT Increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to G1	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline LDH increased, Increase to G1	2 Participants	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline LDH increased, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline LDH increased, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to G1	0 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to G1	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to G3	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to G2	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to G1	1 Participants	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to G2	1 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to G3	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to G1	0 Participants	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to G2	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 170 weeks

Population: Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated.

Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed PR or better as the best overall response (i.e., Partial Response \[PR\], 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). 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; 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; 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Overall Response Rate (ORR)	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated.

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 \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Stringent Complete Response (sCR)	0 Percentage of participants	0 Percentage of participants
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Complete response (CR)	0 Percentage of participants	0 Percentage of participants
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Very Good Partial Response (VGPR)	0 Percentage of participants	0 Percentage of participants
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)	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.

Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 1, Pre-Dose	0.0 nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0	0.0 nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 1, End Of Infusion	30100.0 nanogram/ millilitre (ng/mL) Interval 25900.0 to 36400.0	43400.0 nanogram/ millilitre (ng/mL) Interval 31400.0 to 50000.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 1, 2 hours	29450.0 nanogram/ millilitre (ng/mL) Interval 25100.0 to 32100.0	39700.0 nanogram/ millilitre (ng/mL) Interval 29800.0 to 45800.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 1, 24 hours	18300.0 nanogram/ millilitre (ng/mL) Interval 13700.0 to 27800.0	30900.0 nanogram/ millilitre (ng/mL) Interval 20000.0 to 31000.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 4	9925.0 nanogram/ millilitre (ng/mL) Interval 6240.0 to 15500.0	10700.0 nanogram/ millilitre (ng/mL) Interval 9420.0 to 15500.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 8	3880.0 nanogram/ millilitre (ng/mL) Interval 3530.0 to 4880.0	7180.0 nanogram/ millilitre (ng/mL) Interval 5170.0 to 8220.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 1 Day 22	1060.0 nanogram/ millilitre (ng/mL)	3130.0 nanogram/ millilitre (ng/mL)
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 2 Day 1, Pre-Dose	1415.0 nanogram/ millilitre (ng/mL) Interval 878.0 to 1700.0	1390.0 nanogram/ millilitre (ng/mL) Interval 679.0 to 2720.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 2 Day 1, End Of Infusion	27700.0 nanogram/ millilitre (ng/mL) Interval 24100.0 to 33000.0	42900.0 nanogram/ millilitre (ng/mL) Interval 32500.0 to 54000.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 4 Day 1, Pre-Dose	2635.0 nanogram/ millilitre (ng/mL) Interval 2190.0 to 3080.0	2190.0 nanogram/ millilitre (ng/mL)
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 4 Day 1, End Of Infusion	28200.0 nanogram/ millilitre (ng/mL) Interval 27200.0 to 29200.0	29900.0 nanogram/ millilitre (ng/mL)
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 6 Day 1, Pre-Dose	3600.0 nanogram/ millilitre (ng/mL)	2800.0 nanogram/ millilitre (ng/mL)
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) Cycle 6 Day 1, End Of Infusion	32100.0 nanogram/ millilitre (ng/mL)	27500.0 nanogram/ millilitre (ng/mL)

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: No participants were enrolled in CE Phase as study got terminated.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.

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

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 6 Day 1, End Of Infusion	47500.0 ng/mL	40400.0 ng/mL
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 1, Pre-Dose	0.0 ng/mL Interval 0.0 to 0.0	0.0 ng/mL Interval 0.0 to 0.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 1, End Of Infusion	32650.0 ng/mL Interval 29600.0 to 36400.0	49500.0 ng/mL Interval 38200.0 to 56800.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 1, 2 hours	34500.0 ng/mL Interval 30000.0 to 37000.0	46000.0 ng/mL Interval 37800.0 to 53000.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 1, 24 hours	23650.0 ng/mL Interval 18500.0 to 32900.0	36700.0 ng/mL Interval 26600.0 to 41000.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 4	15900.0 ng/mL Interval 9950.0 to 22000.0	21500.0 ng/mL Interval 16300.0 to 25100.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 8	9770.0 ng/mL Interval 7460.0 to 10400.0	18300.0 ng/mL Interval 10600.0 to 21500.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 1 Day 22	2620.0 ng/mL	—
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 2 Day 1, Pre-Dose	4105.0 ng/mL Interval 2600.0 to 5170.0	3740.0 ng/mL Interval 3070.0 to 8680.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 2 Day 1, End Of Infusion	34000.0 ng/mL Interval 29300.0 to 41800.0	52000.0 ng/mL Interval 40800.0 to 56200.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 4 Day 1, Pre-Dose	6910.0 ng/mL Interval 4560.0 to 11800.0	5430.0 ng/mL
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 4 Day 1, End Of Infusion	40500.0 ng/mL Interval 39100.0 to 40900.0	33200.0 ng/mL
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody Cycle 6 Day 1, Pre-Dose	13100.0 ng/mL	8720.0 ng/mL

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. No participants were enrolled in CE Phase as study got terminated.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.

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

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 1, Pre-Dose	0.00 ng/mL Interval 0.0 to 0.0	0.00 ng/mL Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 1, End Of Infusion	404.00 ng/mL Interval 352.0 to 741.0	623.00 ng/mL Interval 343.0 to 735.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 1, 2 hours	489.00 ng/mL Interval 338.0 to 811.0	527.00 ng/mL Interval 515.0 to 832.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 1, 24 hours	766.50 ng/mL Interval 449.0 to 1760.0	1020.00 ng/mL Interval 722.0 to 1050.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 4	360.50 ng/mL Interval 288.0 to 752.0	492.00 ng/mL Interval 309.0 to 615.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 8	120.00 ng/mL Interval 107.0 to 235.0	234.00 ng/mL Interval 172.0 to 292.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 1 Day 22	0.00 ng/mL	0.00 ng/mL
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 2 Day 1, Pre-Dose	0.00 ng/mL Interval 0.0 to 0.0	0.00 ng/mL Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 2 Day 1, End Of Infusion	384.00 ng/mL Interval 262.0 to 676.0	625.00 ng/mL Interval 353.0 to 796.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 4 Day 1, Pre-Dose	0.00 ng/mL Interval 0.0 to 0.0	0.00 ng/mL
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 4 Day 1, End Of Infusion	548.00 ng/mL Interval 268.0 to 679.0	268.00 ng/mL
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 6 Day 1, Pre-Dose	0.00 ng/mL	0.00 ng/mL
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) Cycle 6 Day 1, End Of Infusion	291.00 ng/mL	179.00 ng/mL

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Population: Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.

Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 1, Pre-Dose	0.0 ng/mL Interval 0.0 to 0.0	0.0 ng/mL Interval 0.0 to 0.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 1, End Of Infusion	1199.5 ng/mL Interval 0.0 to 1478.0	1759.0 ng/mL Interval 1746.0 to 2671.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 1, 24 hours	1078.0 ng/mL Interval 712.0 to 1305.0	1540.0 ng/mL Interval 1427.0 to 1974.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 1, 2-4 hours	1576.0 ng/mL Interval 1137.0 to 1659.0	1888.0 ng/mL Interval 1785.0 to 1889.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 4	576.5 ng/mL Interval 428.0 to 770.0	889.0 ng/mL Interval 751.0 to 1087.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 8	358.0 ng/mL Interval 0.0 to 545.0	737.0 ng/mL Interval 487.0 to 874.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 1 Day 22	0.0 ng/mL	326.0 ng/mL
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 2 Day 1, Pre-Dose	0.0 ng/mL Interval 0.0 to 0.0	0.0 ng/mL Interval 0.0 to 0.0
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 4 Day 1, Pre-Dose	0.0 ng/mL Interval 0.0 to 551.0	0.0 ng/mL
DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin Cycle 6 Day 1, Pre-Dose	0.0 ng/mL	346.0 ng/mL

SECONDARY outcome

Timeframe: Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days)

Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

Serum samples 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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were found positive for ADAs, hence participants were not analyzed for concentration of ADAs.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. There were no participants with positive ADA results. Hence participants were not analyzed for the concentration of ADA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

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. Adverse Events of Special Interest (whether serious or non serious) were collected.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy.

The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. 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.

Outcome measures

Outcome measures
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 Participants Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 Participants Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 1	1 Participants	0 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 2	3 Participants	1 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 3	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Corneal Events were examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

AEs and SAEs were collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Number of participants with AEs leading to discontinuation were evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Number of participants with dose reduction or delay were evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 170 weeks

Population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

Outcome measures

Outcome data not reported

Adverse Events

1.9 mg/kg Belantamab Mafodotin + 8mg OX40

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

2.5 mg/kg Belantamab Mafodotin + 8mg OX40

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	1.9 mg/kg Belantamab Mafodotin + 8mg OX40 n=6 participants at risk Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.	2.5 mg/kg Belantamab Mafodotin + 8mg OX40 n=3 participants at risk Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
Infections and infestations Parainfluenzae virus infection	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Infections and infestations Staphylococcal infection	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Infections and infestations Urosepsis	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Injury, poisoning and procedural complications Femur fracture	16.7% 1/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Injury, poisoning and procedural complications Subdural haemorrhage	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Nervous system disorders Haemorrhage intracranial	16.7% 1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	0.00% 0/3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.
Vascular disorders Peripheral vascular disorder	0.00% 0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.	33.3% 1/3 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 170 weeks. Safety set included all participants who received at least one dose of any component of the combination therapy in the combination arm.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER