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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001138-32 | EudraCT Number |
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The study was terminated due to lack of efficacy.
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The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is the sub study of the Master protocol (NCT04126200).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belantamab mafodotin + GSK3174998 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab Mafodotin | Drug | Belantamab Mafodotin will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DE Phase: Number of Participants With Dose Limiting Toxicities (DLT) | 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. | Up to 21 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. | Up to 170 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 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. | Baseline (Day 1) and up to 170 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fitzroy | Victoria | 3065 | Australia | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | DE Phase: Number of Participants With Dose Limiting Toxicities (DLT) | 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. | 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. | Posted | Count of Participants | Participants | Up to 21 days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Parainfluenzae virus infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratopathy | Eye disorders | MedDRA v25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2020 | Feb 23, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2022 | Jan 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
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| GSK3174998 | Drug | GSK3174998 will be administered. |
|
|
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.
| Baseline (Day 1) and up to 170 weeks |
| Cohort Expansion (CE) Phase: Overall Response Rate (ORR) | 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. | Up to 170 weeks |
| Up to 170 weeks |
| 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 >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%. | Up to 170 weeks |
| 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). 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. | Up to 170 weeks |
| 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. | Up to 170 weeks |
| 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). | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) | Blood samples were collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC). | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody | Blood samples were collected for PK analysis of Belantamab mafodotin total antibody. | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody | Blood samples were collected for PK analysis of Belantamab mafodotin plasma total antibody. | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| 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). | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| CE 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) | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin | Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin. | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| CE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin | Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin. | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
| DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 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. | Up to 170 weeks |
| CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | 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. | Up to 170 weeks |
| DE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40 | 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. | Up to 170 weeks |
| CE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40 | 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. | Up to 170 weeks |
| DE Phase: Concentration of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | Up to 170 weeks |
| CE Phase: Concentration of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | Up to 170 weeks |
| DE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | Up to 170 weeks |
| CE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | Up to 170 weeks |
| DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | 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. | Up to 170 weeks |
| CE Phase: Number of Participants With AESI | 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. | Up to 170 weeks |
| 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. 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. | Up to 170 weeks |
| CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade | Corneal Events were examined. | Up to 170 weeks |
| 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. | Up to 170 weeks |
| 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. | Up to 170 weeks |
| 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). | Up to 170 weeks |
| CE Phase: Overall Survival (OS) | OS is defined as the time from randomization until death due to any cause. | Up to 170 weeks |
| CE Phase: Number of Participants With AEs and SAEs | AEs and SAEs were collected. | Up to 170 weeks |
| CE Phase: Number of Participants With AEs Leading to Discontinuation | Number of participants with AEs leading to discontinuation were evaluated. | Up to 170 weeks |
| CE Phase: Number of Participants With Dose Reduction or Delay | Number of participants with dose reduction or delay were evaluated. | Up to 170 weeks |
| CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters | 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. | Up to 170 weeks |
| CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters | 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. | Up to 170 weeks |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| GSK Investigational Site | Stockholm | SE-141 86 | Sweden |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | 1.9 mg/kg Belantamab Mafodotin + 8mg OX40 | 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. |
| OG001 | 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. |
|
|
| 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Up to 170 weeks |
|
|
|
| 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 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to 170 weeks |
|
|
|
| Primary | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to 170 weeks |
|
|
|
| Primary | Cohort Expansion (CE) Phase: Overall Response Rate (ORR) | 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. | Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated. | Posted | Up to 170 weeks |
|
|
| Secondary | DE Phase: Overall Response Rate (ORR) | 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Number | Percentage of participants | Up to 170 weeks |
|
|
|
| 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 >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%. | Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated. | Posted | Up to 170 weeks |
|
|
| 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). 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Number | Percentage of participants | Up to 170 weeks |
|
|
|
| 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. | Intent to Treat (ITT) population included all the enrolled participants. No participants were enrolled in CE Phase as study got terminated. | Posted | Up to 170 weeks |
|
|
| 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). | Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. | Posted | Median | Full Range | nanogram/ millilitre (ng/mL) | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
|
| Secondary | CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) | Blood samples were collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC). | No participants were enrolled in CE Phase as study got terminated. | Posted | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
| Secondary | DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody | Blood samples were collected for PK analysis of Belantamab mafodotin total antibody. | Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. | Posted | Median | Full Range | ng/mL | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
|
| Secondary | CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody | Blood samples were collected for PK analysis of Belantamab mafodotin plasma total antibody. | 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. | Posted | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
| 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). | Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. | Posted | Median | Full Range | ng/mL | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
|
| Secondary | CE 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) | 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. | Posted | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
| Secondary | DE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin | Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin. | Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. | Posted | Median | Full Range | ng/mL | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
|
| Secondary | CE Phase: OX40 Concentration When Administered in Combination With Belantamab Mafodotin | Blood samples were collected for PK analysis of OX40 when administered intravenously in combination with belantamab mafodotin. | 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. | Posted | Up to Day 1 (End of Infusion) of Cycle 6 (Each Cycle consist of 21 days) |
|
|
| Secondary | DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Up to 170 weeks |
|
|
|
| Secondary | CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | 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. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | DE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40 | 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. | Data was not collected. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With Post-baseline Positive ADAs Against OX40 | 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. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | DE Phase: Concentration of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Concentration of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | DE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Concentration of ADAs Against OX40 When Administered in Combination With Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) | 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Up to 170 weeks |
|
|
|
| Secondary | CE Phase: Number of Participants With AESI | 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. | 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. | Posted | Up to 170 weeks |
|
|
| 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. 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. | Safety Population included all participants who received at least 1 dose of any component of the combination therapy. | Posted | Count of Participants | Participants | Up to 170 weeks |
|
|
|
| Secondary | CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade | Corneal Events were examined. | 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. | Posted | Up to 170 weeks |
|
|
| 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. | 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. | Posted | Up to 170 weeks |
|
|
| 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. | 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. | Posted | Up to 170 weeks |
|
|
| 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). | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Overall Survival (OS) | OS is defined as the time from randomization until death due to any cause. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With AEs and SAEs | AEs and SAEs were collected. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With AEs Leading to Discontinuation | Number of participants with AEs leading to discontinuation were evaluated. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With Dose Reduction or Delay | Number of participants with dose reduction or delay were evaluated. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters | 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. | 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. | Posted | Up to 170 weeks |
|
|
| Secondary | CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters | 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. | 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. | Posted | Up to 170 weeks |
|
|
| 5 |
| 6 |
| 6 |
| 6 |
| 6 |
| 6 |
| EG001 | 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. | 2 | 3 | 1 | 3 | 3 | 3 |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA v25.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Exophthalmos | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
|
| Mass | General disorders | MedDRA v25.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v25.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA v25.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Systematic Assessment |
|
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.
| 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 |
| Eosinophils, Increase to G3 |
|
| Anemia, Increase to G1 |
|
| Anemia, Increase to G2 |
|
| Anemia, Increase to G3 |
|
| Hemoglobin Increased, Increase to G1 |
|
| Hemoglobin Increased, Increase to G2 |
|
| Hemoglobin Increased, Increase to G3 |
|
| Lymphocyte Count Decreased, Increase to G1 |
|
| Lymphocyte Count Decreased, Increase to G2 |
|
| Lymphocyte Count Decreased, Increase to G3 |
|
| Lymphocyte Count Increased, Increase to G1 |
|
| Lymphocyte Count Increased, Increase to G2 |
|
| Lymphocyte Count Increased, Increase to G3 |
|
| Neutrophil Count Decreased, Increase to G1 |
|
| Neutrophil Count Decreased, Increase to G2 |
|
| Neutrophil Count Decreased, Increase to G3 |
|
| Platelet Count Decreased, Increase to G1 |
|
| Platelet Count Decreased, Increase to G2 |
|
| Platelet Count Decreased, Increase to G3 |
|
| Leukocytosis, Increase to G1 |
|
| Leukocytosis, Increase to G2 |
|
| Leukocytosis, Increase to G3 |
|
| White Blood Cell Decreased, Increase to G1 |
|
| White Blood Cell Decreased, Increase to G2 |
|
| White Blood Cell Decreased, Increase to G3 |
|
| Hypoglycemia, Increase to G3 |
|
| Hypoalbuminemia, Increase to G1 |
|
| Hypoalbuminemia, Increase to G2 |
|
| Hypoalbuminemia, Increase to G3 |
|
| ALP Increased, Increase to G1 |
|
| ALP Increased, Increase to G2 |
|
| ALP Increased, Increase to G3 |
|
| ALT Increased, Increase to G1 |
|
| ALT Increased, Increase to G2 |
|
| ALT Increased, Increase to G3 |
|
| AST Increase, Increase to G1 |
|
| AST Increase, Increase to G2 |
|
| AST Increase, Increase to G3 |
|
| Blood bilirubin Increased, Increase to G1 |
|
| Blood bilirubin Increased, Increase to G2 |
|
| Blood bilirubin Increased, Increase to G3 |
|
| CPK Increased, Increase to G1 |
|
| CPK Increased, Increase to G2 |
|
| CPK Increased, Increase to G3 |
|
| Creatinine Increased, Increase to G1 |
|
| Creatinine Increased, Increase to G2 |
|
| Creatinine Increased, Increase to G3 |
|
| GGT Increased, Increase to G1 |
|
| GGT Increased, Increase to G2 |
|
| GGT Increased, Increase to G3 |
|
| Hyperkalemia, Increase to G1 |
|
| Hyperkalemia, Increase to G2 |
|
| Hyperkalemia, Increase to G3 |
|
| LDH increased, Increase to G1 |
|
| LDH increased, Increase to G2 |
|
| LDH increased, Increase to G3 |
|
| Hypermagnesemia, Increase to G1 |
|
| Hypermagnesemia, Increase to G2 |
|
| Hypermagnesemia, Increase to G3 |
|
| Hypomagnesemia, Increase to G1 |
|
| Hypomagnesemia, Increase to G2 |
|
| Hypomagnesemia, Increase to G3 |
|
| Hypernatremia, Increase to G1 |
|
| Hypernatremia, Increase to G2 |
|
| Hypernatremia, Increase to G3 |
|
| Hypercalcemia, Increase to G1 |
|
| Hypercalcemia, Increase to G2 |
|
| Hypercalcemia, Increase to G3 |
|
| Hypocalcemia, Increase to G1 |
|
| Hypocalcemia, Increase to G2 |
|
| Hypocalcemia, Increase to G3 |
|
| GFR from creatinine/Chronic Kidney Disease, Increase to G1 |
|
| GFR from creatinine/Chronic Kidney Disease, Increase to G2 |
|
| GFR from creatinine/Chronic Kidney Disease, Increase to G3 |
|
| Very Good Partial Response (VGPR) |
|
| Partial response (PR) |
|
| Cycle 1 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, 2 hours |
|
|
| Cycle 1 Day 1, 24 hours |
|
|
| Cycle 1 Day 4 |
|
|
| Cycle 1 Day 8 |
|
|
| Cycle 1 Day 22 |
|
|
| Cycle 2 Day 1, Pre-Dose |
|
|
| Cycle 2 Day 1, End Of Infusion |
|
|
| Cycle 4 Day 1, Pre-Dose |
|
|
| Cycle 4 Day 1, End Of Infusion |
|
|
| Cycle 6 Day 1, Pre-Dose |
|
|
| Cycle 6 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, 2 hours |
|
|
| Cycle 1 Day 1, 24 hours |
|
|
| Cycle 1 Day 4 |
|
|
| Cycle 1 Day 8 |
|
|
| Cycle 1 Day 22 |
|
|
| Cycle 2 Day 1, Pre-Dose |
|
|
| Cycle 2 Day 1, End Of Infusion |
|
|
| Cycle 4 Day 1, Pre-Dose |
|
|
| Cycle 4 Day 1, End Of Infusion |
|
|
| Cycle 6 Day 1, Pre-Dose |
|
|
| Cycle 6 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, 2 hours |
|
|
| Cycle 1 Day 1, 24 hours |
|
|
| Cycle 1 Day 4 |
|
|
| Cycle 1 Day 8 |
|
|
| Cycle 1 Day 22 |
|
|
| Cycle 2 Day 1, Pre-Dose |
|
|
| Cycle 2 Day 1, End Of Infusion |
|
|
| Cycle 4 Day 1, Pre-Dose |
|
|
| Cycle 4 Day 1, End Of Infusion |
|
|
| Cycle 6 Day 1, Pre-Dose |
|
|
| Cycle 6 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, End Of Infusion |
|
|
| Cycle 1 Day 1, 24 hours |
|
|
| Cycle 1 Day 1, 2-4 hours |
|
|
| Cycle 1 Day 4 |
|
|
| Cycle 1 Day 8 |
|
|
| Cycle 1 Day 22 |
|
|
| Cycle 2 Day 1, Pre-Dose |
|
|
| Cycle 4 Day 1, Pre-Dose |
|
|
| Cycle 6 Day 1, Pre-Dose |
|
|
| Grade 3 |
|