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This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone compared with that of combination of pomalidomide, bortezomib and dexamethasone in Japanese participants with relapsed/refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belantamab mafodotin plus Pomalidomide and Dexamethasone | Experimental |
| |
| Bortezomib plus Pomalidomide and Dexamethasone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin | Drug | Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis. | Up to approximately 120 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. | Up to approximately 407 weeks |
| Duration of Response (DoR) |
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Inclusion Criteria:
Capable of giving signed informed consent.
Male or female, 18 years or older.
Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).
Must have at least 1 aspect of measurable disease defined as one of the following;
Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
Adequate organ system functions as mentioned in the protocol.
Male and female participants agree to abide by protocol-defined contraceptive requirements.
In Japan, Hepatitis B participants who are hepatitis B surface antigen (HbsAg)- (e.g. HBsAb+/HbsAg-, HBcAb+/HbsAg-, HBcAb+/HBsAb+/HbsAg-) are eligible for inclusion in this study if hepatitis B virus (HBV) DNA is undetectable. A patient with HBsAg+ is eligible if HBV DNA is undetectable after assessing hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb) and HBV DNA, and if a hepatologist agrees with the participation into this study.
Exclusion Criteria:
Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
Prior allogeneic SCT.
Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
Plasmapheresis within 7 days prior to the first dose of study drug.
Received prior treatment with or intolerant to pomalidomide.
Received prior Beta cell maturation antigen (BCMA) targeted therapy.
Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).
Evidence of cardiovascular risk including any of the following;
Any major surgery within the last 4 weeks.
Previous or concurrent invasive malignancy other than multiple myeloma, except:
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Evidence of active mucosal or internal bleeding.
Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Active infection requiring treatment.
Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
Active or history of venous and arterial thromboembolism within the past 3 months.
Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
Current corneal disease except for mild punctate keratopathy.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Pregnant or lactating female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| GSK Investigational Site |
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
This study enrolled a total of 12 Japanese participants and the analyses included 9 Japanese participants that had been previously enrolled in the global study for 207499 (NCT04484623), resulting in a total of 21 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 24, 2025 | May 27, 2025 |
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| Pomalidomide | Drug | Immunomodulatory drug (IMiD) will be administered. |
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| Dexamethasone | Drug | Synthetic glucocorticoid with anti-tumor activity will be administered. |
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| Bortezomib | Drug | Proteasome Inhibitor will be administered. |
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Duration of Response (DoR) defined as the time from first documented evidence of partial response (PR) or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
| Up to approximately 407 weeks |
| Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. | Up to approximately 407 weeks |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Up to approximately 407 weeks |
| Complete Response Rate (CRR) | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. | Up to approximately 407 weeks |
| Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Up to approximately 407 weeks |
| Time to Best Response (TTBR) | Time to Best Response (TTBR) defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. | Up to approximately 407 weeks |
| Time to Response (TTR) | Time to Response (TTR) 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 (i.e., confirmed PR or better) based on IRC-assessment per IMWG. | Up to approximately 407 weeks |
| Time to Progression (TTP) | Time to Progression (TTP) defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. | Up to approximately 407 weeks |
| Progression-free Survival on Subsequent Line of Therapy (PFS2) | PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. | Up to approximately 407 weeks |
| 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 treatment, whether or not considered related to the study treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary). | Up to approximately 407 weeks |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples will be collected for the analysis of hematology parameters. | Up to approximately 407 weeks |
| Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples will be collected for the analysis of clinical chemistry parameters. | Up to approximately 407 weeks |
| Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to approximately 407 weeks |
| Plasma Concentrations of Belantamab Mafodotin (ADC) | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to approximately 407 weeks |
| Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to approximately 407 weeks |
| Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone | Up to approximately 407 weeks |
| Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 407 weeks |
| Maximum Concentration (Cmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 407 weeks |
| Time of Cmax (Tmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 407 weeks |
| Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 407 weeks |
| Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Up to approximately 407 weeks |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers. | Up to approximately 407 weeks |
| Titers of ADAs Against Belantamab Mafodotin | Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be further tested in screening assay, and positive samples will be further characterized for antibody titers. | Up to approximately 407 weeks |
| Number of Participants With Maximum Post-baseline Changes in Patient-reported Outcome Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores for Each Item Attribute | The PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 ("never," "none," "not at all," or "absent") to 4 ("almost constantly," "very severe," or "very much"), with a higher score indicating a higher frequency, severity, or interference of adverse events. | Up to approximately 407 weeks |
| Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Baseline and up to approximately 407 weeks |
| Change From Baseline in HRQoL as Measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Baseline and up to approximately 407 weeks |
| Change From Baseline in HRQoL as Measured by EORTC Item Library 52 (IL52) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Baseline and up to approximately 407 weeks |
| Kamogawa |
| Chiba |
| 296-8602 |
| Japan |
| GSK Investigational Site | Kashiwa | Chiba | 277-8567 | Japan |
| GSK Investigational Site | Matsuyama | Ehime | 790-8524 | Japan |
| GSK Investigation Site | Fukushima | Fukushima | 960-1295 | Japan |
| GSK Investigational Site | Maebashi | Gunma | 371-8511 | Japan |
| GSK Investigational Site | Shibukawa | Gunma | 377-0280 | Japan |
| GSK Investigational Site | Numakunai | Iwate | 028-3695 | Japan |
| GSK Investigational Site | Okayama | Okayama-ken | 701-1192 | Japan |
| GSK Investigational Site | Osaka | Osaka | 565-0871 | Japan |
| GSK Investigational Site | Tottori-shi | Tottori | 683-8504 | Japan |
| GSK Investigational Site | Yamagata | Yamagata | 990-9585 | Japan |
| GSK Investigational Site | Hokkaido | 060-8648 | Japan |
| FG001 | Bortezomib + Pomalidomide + Dexamethasone | Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| BG001 | Bortezomib + Pomalidomide + Dexamethasone | Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD is defined as increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5 grams per deciliter {g/dL}]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200 milligrams per 24 hours {mg/24h}]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved serum free light chains (sFLC) levels [absolute increase >10mg/dL]; appearance of new lesion,>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in longest diameter of previous lesion >1 centimeter (cm) in short axis. | Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 120 weeks |
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| Secondary | Overall Survival (OS) | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | Duration of Response (DoR) defined as the time from first documented evidence of partial response (PR) or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Best Response (TTBR) | Time to Best Response (TTBR) defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | Time to Response (TTR) 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 (i.e., confirmed PR or better) based on IRC-assessment per IMWG. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time to Progression (TTP) defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival on Subsequent Line of Therapy (PFS2) | PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 treatment, whether or not considered related to the study treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary). | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples will be collected for the analysis of hematology parameters. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Blood samples will be collected for the analysis of clinical chemistry parameters. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (C(Tlast)) [AUC (0-last)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time of Cmax (Tmax) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Pomalidomide | Blood samples will be collected for PK analysis of Pomalidomide in combination with belantamab mafodotin and dexamethasone. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Titers of ADAs Against Belantamab Mafodotin | Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be further tested in screening assay, and positive samples will be further characterized for antibody titers. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Post-baseline Changes in Patient-reported Outcome Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores for Each Item Attribute | The PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 ("never," "none," "not at all," or "absent") to 4 ("almost constantly," "very severe," or "very much"), with a higher score indicating a higher frequency, severity, or interference of adverse events. | Not Posted | Nov 2030 | Up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) | The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These includes five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Not Posted | Nov 2030 | Baseline and up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL as Measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score for Future Perspective and Body Image represents a high/healthy level of functioning. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Not Posted | Nov 2030 | Baseline and up to approximately 407 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL as Measured by EORTC Item Library 52 (IL52) | The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to 100. A high score for disease symptoms represents a high level of symptomatology or problems. Baseline is defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline is calculated by subtracting Baseline value from the post-dose visit value. | Not Posted | Nov 2030 | Baseline and up to approximately 407 weeks | Participants |
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 120 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Safety population included all randomized participants who received at least 1 dose of study intervention (any component).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belantamab Mafodotin+Pomalidomide+Dexamethasone | Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. | 2 | 10 | 5 | 10 | 10 | 10 |
| EG001 | Bortezomib + Pomalidomide + Dexamethasone | Japanese participants with RRMM received subcutaneous (SC) injection of 1.3 mg/meter^2(m^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first. | 1 | 11 | 4 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus node dysfunction | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Morganella infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Dermatophytosis of nail | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Oral contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Albumin urine present | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Basophil count increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Coagulation test abnormal | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Cytomegalovirus test positive | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v26.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2024 | May 27, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|