| Primary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | All treated population included all eligible participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Up to 24 months and 21 days | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; important medical events that may jeopardize the participant or may require medical or surgical intervention; is associated with liver injury and impaired liver function. | | Posted | | Count of Participants | | Participants | | Up to 24 months and 21 days | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Primary | Number of Participants With Dose Limited Toxicities (DLTs) | An event was considered DLT if it occurred within 21 days of treatment and met any of the following criteria within same period:
- Any Grade (Gr.) 3 or greater non-hematologic toxicity as described in NCI-CTCAE Version 5.0, other than corneal events that persists for >48 hours despite supportive treatment or leads to hospitalization.
- Hematologic toxicity such as Gr. 3 or greater febrile neutropenia lasting >48 hours despite adequate treatment (Gr. 3 defined as absolute neutrophil count (ANC) <1000/millimeter cube (mm^3) at a single temperature >38.3 degree celsius or a sustained temperature >=38 degree celsius for more than 1 hour) and, Gr. 4 thrombocytopenia defined as platelet count <25000/mm^3 with clinically significant bleeding, or if platelet transfusion is required.
- Gr. 4 per the corneal grading scale.
- Liver toxicity meeting pre-specified by GSK liver stopping criteria.
| DLT evaluable population included all the eligible participants who have received the 1st dose as planned and experienced a DLT during the cycle 1 or completed the cycle 1. | Posted | | Count of Participants | | Participants | | Day 1 to day 21 of cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC[0-t]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC[0-t] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. | Pharmacokinetic (PK) population, was defined as those participants in the "All treated" population from whom at least one PK sample was obtained, analyzed, and was measurable. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*microgram per milliliter (h*ug/mL) | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | AUC[0-t] of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC[0-t] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | AUC[0-t] of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC[0-t] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter (h*ng/mL) | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Area Under the Concentration-time Curve During the Dosing Interval (AUC[0-tau]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | AUC[0-tau] of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Area Under the Concentration-time Curve From Time 0 to 168h (AUC[0-168]) of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Up to 168 hours | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | AUC[0-infinity] of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | AUC[0-infinity] of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter (ug/mL) | | Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | CEOI of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | | Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Maximum Observed Concentration (Cmax) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Cmax of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Cmax of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle. | Pharmacokinetic (PK) population | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Time to Reach Maximum Observed Concentration (Tmax) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Tmax of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Tmax of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Tlast of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Tlast of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population | Posted | | Median | Full Range | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Systemic Clearance (CL) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/h) | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | CL of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/h | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Systemic Clearance Normalized by Body Weight (CL/Weight) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per hour per kilogram | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | CL/Weight of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per hour per kilogram | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Volume of Distribution at Steady State (Vss) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
|---|
| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Vss of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Volume of Distribution at Steady State Normalized by Body Weight (Vss/Weight) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per kilogram (mL/kg) | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Vss/Weight of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/kg | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Apparent Terminal Half-life (t1/2) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | t1/2 of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | t1/2 of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour | | Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC) | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 1, 3, 5, 8 and 11 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Ctrough of Belantamab Mafodotin Total Antibody | Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. | Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 1, 3, 5, 8 and 11 (each cycle is of 21 days) | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Number of Participants With Abnormal Vital Signs | Abnormal vital signs were defined as any abnormal findings in the vital signs parameters (temperature, blood pressure and pulse rate). | | Posted | | Count of Participants | | Participants | | Up to 21 months | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes | Blood samples were collected at indicated time points to assess change from baseline in hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Worst case grade increase from baseline grade was provided for all the hematology tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits. | | Posted | | Count of Participants | | Participants | | Baseline (day 1) and up to 21 months | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters | Blood samples were collected at indicated time points to assess change from baseline in albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatine kinase, gamma glutamyl transferase, potassium, lactate dehydrogenase, magnesium. Worst case grade (G) increase from baseline grade was provided for all the chemistry tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits. | | Posted | | Count of Participants | | Participants | | Baseline (day 1) and up to 21 months | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]) as assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016. PR=response greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg per 24 hours. CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. sCR=complete response below plus normal free light chain (FLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or 8-color, 2 tube multiparametric flow cytometry. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-component level <100 mg/24 h. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 21 months | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples were analyzed for the presence of anti-belantamab mafodotin antibodies by a validated electro chemiluminescent immunoassay. All samples were tested in a screening assay to identify potentially positive samples. | | Posted | | Count of Participants | | Participants | | Up to 24 months and 21 days | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Titers of ADAs Against Belantamab Mafodotin | Samples were analyzed for the presence of anti-belantamab mafodotin antibodies by a validated electro chemiluminescent immunoassay. All samples were tested in a screening assay to identify potentially positive samples. Screened positive was further characterized for the antibody titer values. | All Treated Population. Only the participants who showed positive results for ADAs were analyzed. | Posted | | Number | | Titer | | Up to 24 months and 21 days | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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| Secondary | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | The OSDI instrument measures vision-related function. The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). The 12 items questionnaire assessed ocular symptoms, visual-related functioning and environmental triggers. Scores ranged from 0 to 100, with higher scores indicating a worse status. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits. | | Posted | | Mean | Standard Deviation | Scores on Scale | | Baseline (day 1) Up to 24 months and 21 days | | | | ID | Title | Description |
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| OG000 | Belantamab Mafodotin | Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal. |
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