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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510537-28-00 | EU Trial (CTIS) Number |
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This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) | Experimental |
| |
| Daratumumab and Bortezomib plus Dexamethasone (Arm B) | 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 |
|
| 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= 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 41 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | CRR is defined as percentage of participants with a confirmed complete response or better. | Up to 73 months |
| Overall Response Rate (ORR) | ORR is defined as percentage of participants with a confirmed partial response or better. |
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Inclusion Criteria:
Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Must have at least 1 aspect of measurable disease, defined as one of the following;
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrollment, except for alopecia.
Adequate organ function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Yuma | Arizona | 85364 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40763276 | Derived | Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949. | |
| 40680754 |
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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/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter^2 (m^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. |
| 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 | Sep 20, 2023 | Sep 27, 2024 |
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| Daratumumab | Drug | Anti-cluster of differentiation 38 [CD-38] monoclonal antibody |
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| Bortezomib | Drug | Proteasome Inhibitor |
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| Dexamethasone | Drug | Synthetic glucocorticoid with anti-tumor activity |
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| Up to 73 months |
| Clinical Benefit Rate (CBR) | CBR is defined as percentage of participants with a confirmed minimal response (MR) or better | Up to 73 months |
| Duration of Response (DoR) | DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first. | Up to 73 months |
| Time to Response (TTR) | TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better. | Up to 73 months |
| Time to Progression (TTP) | TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first. | Up to 73 months |
| Overall Survival (OS) | OS is defined as time from the date of randomization until the date of death due to any cause. | Up to 73 months |
| Progression-free Survival on Subsequent Line of Therapy (PFS2) | Progression-free survival on subsequent line of therapy is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. 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 73 months |
| Minimal Residual Disease (MRD) Negativity Rate | Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS). | Up to 73 months |
| 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. | Up to 73 months |
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Blood samples will be collected for the analysis of hematology parameters. | Up to 73 months |
| Number of Participants With Clinically Significant Changes in Clinical Chemistry | Blood samples will be collected for the analysis of clinical chemistry parameters. | Up to 73 months |
| Number of Participants With Clinically Significant Changes in Urine Dipstick | Urine samples will be collected for the urine dipstick analysis. | Up to 73 months |
| Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Up to 73 months |
| Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to 73 months |
| Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to 73 months |
| Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Up to 73 months |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples 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 73 months |
| Titers of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further to be characterized for antibody titers. | Up to 73 months |
| Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. | Up to 73 months |
| Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization 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 included 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 were 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 was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Up to 73 months |
| Change From Baseline in HRQoL as Measured by EORTC 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 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning. | Up to 73 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| GSK Investigational Site | Kansas City | Kansas | 66205 | United States |
| GSK Investigational Site | Fairfield | Ohio | 45242 | United States |
| GSK Investigational Site | Tyler | Texas | 75702 | United States |
| GSK Investigational Site | Liverpool | New South Wales | 2170 | Australia |
| GSK Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| GSK Investigational Site | Benowa | Queensland | 4217 | Australia |
| GSK Investigational Site | Brussels | 1090 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Roeselare | 8800 | Belgium |
| GSK Investigational Site | Beijing | 100191 | China |
| GSK Investigational Site | Jinan | 250012 | China |
| GSK Investigational Site | Shenyang | 110001 | China |
| GSK Investigational Site | Alexandroupoli | 68 100 | Greece |
| GSK Investigational Site | Athens | 11528 | Greece |
| GSK Investigational Site | Thessaloniki | 54007 | Greece |
| GSK Investigational Site | Tel Aviv | 64239 | Israel |
| GSK Investigational Site | Bergamo | 24127 | Italy |
| GSK Investigational Site | Meldola FC | 47014 | Italy |
| GSK Investigational Site | Milan | 20133 | Italy |
| GSK Investigational Site | Siena | 53100 | Italy |
| GSK Investigational Site | Aichi | 441-8570 | Japan |
| GSK Investigational Site | Aichi | 467-8602 | Japan |
| GSK Investigational Site | Aomori | 030-8553 | Japan |
| GSK Investigational Site | Ehime | 790-8524 | Japan |
| GSK Investigational Site | Fukuoka | 806-8501 | Japan |
| GSK Investigational Site | Fukuoka | 807-8555 | Japan |
| GSK Investigational Site | Fukuoka | 810-8563 | Japan |
| GSK Investigational Site | Fukuoka | 815-8555 | Japan |
| GSK Investigational Site | Gifu | 503-8502 | Japan |
| GSK Investigational Site | Gunma | 377-0280 | Japan |
| GSK Investigational Site | Hyōgo | 670-8540 | Japan |
| GSK Investigational Site | Kanagawa | 221-0855 | Japan |
| GSK Investigational Site | Kanagawa | 247-8533 | Japan |
| GSK Investigational Site | Kochi | 781-8555 | Japan |
| GSK Investigational Site | Nagano | 392-8510 | Japan |
| GSK Investigational Site | Okayama | 701-1192 | Japan |
| GSK Investigational Site | Osaka | 530-0012 | Japan |
| GSK Investigational Site | Osaka | 545-8586 | Japan |
| GSK Investigational Site | Shizuoka | 411-8777 | Japan |
| GSK Investigational Site | Dordrecht | 3318 AT | Netherlands |
| GSK Investigational Site | Groningen | 9713 GZ | Netherlands |
| GSK Investigational Site | Chorzów | 41-500 | Poland |
| GSK Investigational Site | Krakow | 30510 | Poland |
| GSK Investigational Site | Lodz | 93-513 | Poland |
| GSK Investigational Site | Lublin | 20-081 | Poland |
| GSK Investigational Site | Lublin | 20-090 | Poland |
| GSK Investigational Site | Nowy Sącz | 33-300 | Poland |
| GSK Investigational Site | Poznan | 60-569 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Moscow | 125284 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603126 | Russia |
| GSK Investigational Site | Novosibirsk | 630087 | Russia |
| GSK Investigational Site | Saint Petersburg | 191024 | Russia |
| GSK Investigational Site | Saint Petersburg | 197 089 | Russia |
| GSK Investigational Site | Saratov | 410028 | Russia |
| GSK Investigational Site | Ufa | 450083 | Russia |
| GSK Investigational Site | Pusan | 49241 | South Korea |
| GSK Investigational Site | Ulsan | 44033 | South Korea |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08916 | Spain |
| GSK Investigational Site | Cáceres | 10003 | Spain |
| GSK Investigational Site | Gijón | 33394 | Spain |
| GSK Investigational Site | L'Hospitalet de Llobrega | 08908 | Spain |
| GSK Investigational Site | Murcia | 30008 | Spain |
| GSK Investigational Site | PamplonaNavarra | 31008 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
| Derived |
| Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Martinez GA, Sureda Balari A, Sandhu I, Cerchione C, Ganly P, Dimopoulos MA, Fu C, Garg M, Abdallah AO, Gatt ME, Oriol Rocafiguera A, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Ficek J, Mantero A, Pirooz N, Varghese S, Lee J, McKeown A, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Mukhopadhyay P, Nielsen J, Opalinska J, Mateos MV; DREAMM-7 study investigators. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Aug;26(8):1067-1080. doi: 10.1016/S1470-2045(25)00330-4. Epub 2025 Jul 15. |
| 40680752 | Derived | Hungria V, Hus M, Fu C, Zherebtsova V, Ward C, Ho PJ, Mikulski D, Muronova L, Cerchione C, Loubert A, Bunod L, M'Hari M, Pirooz N, Rogers R, Lin CP, Roy-Ghanta S, Opalinska JB, Purser M, McKeown A, McNamara S, Baig H, Eccersley L, Pompilus F, Mateos MV; DREAMM-7 trial study group. Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Aug;12(8):e599-e610. doi: 10.1016/S2352-3026(25)00163-2. Epub 2025 Jul 15. |
| 38828933 | Derived | Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Ribas de Almeida AC, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Aparecida Martinez G, Sureda Balari AM, Sandhu I, Cerchione C, Ganly P, Dimopoulos M, Fu C, Garg M, Abdallah AO, Oriol A, Gatt ME, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Pirooz N, McKeown A, McNamara S, Zhou X, Nichols M, Lewis E, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Opalinska J, Mateos MV; DREAMM-7 Investigators. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. |
| FG001 | Daratumumab + Bor + Dex | Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. |
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| Safety Population | Participants randomized who took at least 1 dose of study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter^2 (m^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. |
| BG001 | Daratumumab + Bor + Dex | Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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= 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 of all randomized participants whether or not randomized treatment was administered. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 41 months |
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| Secondary | Complete Response Rate (CRR) | CRR is defined as percentage of participants with a confirmed complete response or better. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR is defined as percentage of participants with a confirmed partial response or better. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | CBR is defined as percentage of participants with a confirmed minimal response (MR) or better | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as time from the date of randomization until the date of death due to any cause. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Progression-free survival on subsequent line of therapy is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. 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 | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS). | Not Posted | Jun 2027 | Up to 73 months | 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. | Not Posted | Jun 2027 | Up to 73 months | 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 | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Chemistry | Blood samples will be collected for the analysis of clinical chemistry parameters. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Urine Dipstick | Urine samples will be collected for the urine dipstick analysis. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination | Not Posted | Jun 2027 | Up to 73 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Belantamab Mafodotin (Total Antibody) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points | Blood samples will be collected for PK analysis of belantamab mafodotin. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Serum samples 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 | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Titers of ADAs Against Belantamab Mafodotin | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be to be further tested in screening assay, and positive samples will be further to be characterized for antibody titers. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) | The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by EuropeanOrganization 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 included 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 were 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 was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. | Not Posted | Jun 2027 | Up to 73 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HRQoL as Measured by EORTC 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 to100. A high score for disease symptoms represents a high level of symptomatology or problems. A high score represents a high/healthy level of functioning. | Not Posted | Jun 2027 | Up to 73 months | Participants |
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 41 months. 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 took at least 1 dose of study treatment.
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 + Bortezomib (Bor) + Dexamethasone (Dex) | Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter^2 (m^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. | 50 | 242 | 121 | 242 | 238 | 242 |
| EG001 | Daratumumab + Bor + Dex | Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles. | 77 | 246 | 90 | 246 | 239 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Joint abscess | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Leishmaniasis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Gastrointestinal polyp haemorrhage | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Peroneal nerve injury | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA V(22) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA V(22) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Malignant neoplasm of conjunctiva | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V(22) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA V(22) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA V(22) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA V(22) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA V(22) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V(22) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA V(22) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V(22) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA V(22) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V(22) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V(22) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V(22) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA V(22) | 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 | Nov 17, 2023 | Sep 27, 2024 | 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 |
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|