Actively Recruiting
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
Led by GlaxoSmithKline · Updated on 2026-04-22
520
Participants Needed
181
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
CONDITIONS
Official Title
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old or legal age of consent
- Able to provide signed informed consent
- Newly diagnosed multiple myeloma requiring treatment according to IMWG criteria
- At least one measurable disease aspect: urine M-protein excretion ≥200 mg/24 hours, or serum M-protein concentration ≥0.5 g/dL, or serum free light-chain level ≥10 mg/dL with abnormal ratio
- Not eligible for high-dose chemotherapy with autologous stem cell transplant due to age restrictions or comorbid conditions
- ECOG performance status of 0 to 2
- Adequate organ function based on lab assessments
- Male participants must agree to contraception use or abstinence during treatment and for 6 months after last dose
- Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential
- Female participants of childbearing potential must have two negative pregnancy tests before starting treatment
You will not qualify if you...
- Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS syndrome, or Primary Plasma Cell Leukemia
- Prior systemic therapy for multiple myeloma or smoldering multiple myeloma
- Signs of meningeal or central nervous system involvement with multiple myeloma
- Major surgery within 2 weeks before first dose or not fully recovered from surgery (except kyphoplasty)
- Serious or unstable medical or psychiatric disorders interfering with safety or compliance
- Active liver or biliary disease except certain stable conditions
- Previous or concurrent malignancies other than multiple myeloma unless stable for at least 2 years
- Significant cardiovascular risk including untreated arrhythmias, recent myocardial infarction or acute coronary syndromes, or severe heart failure
- Known HIV infection unless stable on treatment with viral load <400 copies/mL and CD4+ count ≥350 cells/µL
- Positive hepatitis C tests unless successfully treated and viral load negative
- Participants with hepatitis B unless meeting defined criteria
- Current corneal epithelial disease except mild punctate keratopathy
- Intolerance or contraindication to antiviral prophylaxis
- Unable to tolerate antithrombotic prophylaxis
- Known hypersensitivity to belantamab mafodotin or study drug components
- Plasmapheresis within 7 days before first dose
- Receipt of live or live-attenuated vaccine within 30 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 181 locations
1
GSK Investigational Site
Mobile, Alabama, United States, 36607
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2
GSK Investigational Site
Phoenix, Arizona, United States, 85054
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3
GSK Investigational Site
Beverly Hills, California, United States, 90211
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4
GSK Investigational Site
Pasadena, California, United States, 91105
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5
GSK Investigational Site
Aurora, Colorado, United States, 80012
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6
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20007
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7
GSK Investigational Site
Englewood, Florida, United States, 34223
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8
GSK Investigational Site
Lady Lake, Florida, United States, 32159
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9
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
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10
GSK Investigational Site
Saint Augustine, Florida, United States, 32256
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11
GSK Investigational Site
Atlanta, Georgia, United States, 30322
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12
GSK Investigational Site
Portland, Maine, United States, 04074
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13
GSK Investigational Site
Worcester, Massachusetts, United States, 01655
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14
GSK Investigational Site
Ann Arbor, Michigan, United States, 48103
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15
GSK Investigational Site
Detroit, Michigan, United States, 48201
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16
GSK Investigational Site
Billings, Montana, United States, 59102
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17
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
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18
GSK Investigational Site
New York, New York, United States, 10065
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19
GSK Investigational Site
Stony Brook, New York, United States, 11790
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20
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
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21
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
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22
GSK Investigational Site
Columbus, Ohio, United States, 43214
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23
GSK Investigational Site
Providence, Rhode Island, United States, 02903
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24
GSK Investigational Site
Austin, Texas, United States, 78705
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25
GSK Investigational Site
Austin, Texas, United States, 78712
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26
GSK Investigational Site
Kingwood, Texas, United States, 77339
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27
GSK Investigational Site
San Antonio, Texas, United States, 78240
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28
GSK Investigational Site
Tyler, Texas, United States, 75702
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29
GSK Investigational Site
Fairfax, Virginia, United States, 22031
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30
GSK Investigational Site
Puyallup, Washington, United States, 98373
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31
GSK Investigational Site
Capital Federal, Argentina, C1426ANZ
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32
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1414
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33
GSK Investigational Site
Córdoba, Argentina
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34
GSK Investigational Site
Rosario, Argentina, S2002
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35
GSK Investigational Site
Viedma, Argentina, R8500ACE
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36
GSK Investigational Site
Gosford NSW, New South Wales, Australia, 2250
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37
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
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38
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
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39
GSK Investigational Site
Fitzroy, Australia
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40
GSK Investigational Site
Herston, Australia
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41
GSK Investigational Site
St Leonards, Australia
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42
GSK Investigational Site
Bruges, Belgium, 8000
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43
GSK Investigational Site
Brussels, Belgium, 1200
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44
GSK Investigational Site
Ghent, Belgium, 9000
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45
GSK Investigational Site
Hornu, Belgium, 7301
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46
GSK Investigational Site
Roeselare, Belgium, 8800
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47
GSK Investigational Site
Salvador, Estado de Bahia, Brazil
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48
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
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49
GSK Investigational Site
Barretos, Brazil, 14784-400
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50
GSK Investigational Site
Joinville, Brazil, 89201-260
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51
GSK Investigational Site
Porto Alegre, Brazil
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52
GSK Investigational Site
São Paulo, Brazil, 01509-010
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53
GSK Investigational Site
São Paulo, Brazil, 04537-080
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54
GSK Investigational Site
São Paulo, Brazil, 05403-000
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55
GSK Investigational Site
São Paulo, Brazil
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56
GSK Investigational Site
Teresina, Brazil, 64049-200
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57
GSK Investigational Site
Vitória, Brazil, 29043-260
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58
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 4L2
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59
GSK Investigational Site
Beijing, China, 100191
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60
GSK Investigational Site
Chengdu, China, 610072
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61
GSK Investigational Site
Chongqing, China, 400016
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62
GSK Investigational Site
Guangzhou, China, 510060
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63
GSK Investigational Site
Guangzhou, China, 510515
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64
GSK Investigational Site
Hangzhou, China, 310003
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65
GSK Investigational Site
Nanchang, China, 330000
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66
GSK Investigational Site
Nanchang, China
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67
GSK Investigational Site
Nanjing, China, 210008
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68
GSK Investigational Site
Shanghai, China, 200032
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69
GSK Investigational Site
Shanghia, China, 200080
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70
GSK Investigational Site
Shenzhen, China, 430022
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71
GSK Investigational Site
Shenzhen, China, 518039
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72
GSK Investigational Site
Tianjin, China, 300020
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73
GSK Investigational Site
Wenzhou, China, 325000
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74
GSK Investigational Site
Xi'an, China, 710004
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75
GSK Investigational Site
Ostrava, Czechia, 708 52
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76
GSK Investigational Site
Prague, Czechia, 100 34
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77
GSK Investigational Site
Bobigny, France, 93009
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78
GSK Investigational Site
Nantes, France, 44202
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79
GSK Investigational Site
Villejuif, France, 94805
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80
GSK Investigational Site
Jena, Europe, Germany, 7747
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81
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany, 23538
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82
GSK Investigational Site
Chemnitz, Germany, 9116
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83
GSK Investigational Site
Cologne, Germany, 50937
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84
GSK Investigational Site
Dresden, Germany, 01307
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85
GSK Investigational Site
Hamburg, Germany, 20246
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86
GSK Investigational Site
Hanover, Germany, 30625
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87
GSK Investigational Site
Mainz, Germany, 55131
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88
GSK Investigational Site
Würzburg, Germany, 97080
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89
GSK Investigational Site
Alexandroupoli, Greece, 68 100
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90
GSK Investigational Site
Athens, Greece, 106 76
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91
GSK Investigational Site
Athens, Greece, 115 28
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92
GSK Investigational Site
Athens, Greece
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93
GSK Investigational Site
Pátrai, Greece, 26504
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94
GSK Investigational Site
Thessaloniki, Greece, 54007
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95
GSK Investigational Site
Ahmedabad, India, 380009
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96
GSK Investigational Site
Bangalore, India, 560054
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97
GSK Investigational Site
Hyderabad, India, 500033
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98
GSK Investigational Site
Kolkata, India, 700014
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99
GSK Investigational Site
Kolkata, India, 700156
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100
GSK Investigational Site
Pune, India, 411001
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101
GSK Investigational Site
Sushrut Hospital and Research, India, 400071
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102
GSK Investigational Site
Dublin, Ireland, D09V2N0
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103
GSK Investigational Site
Galway, Ireland
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104
GSK Investigational Site
Waterford, Ireland
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105
GSK Investigational Site
Beersheba, Israel, 84101
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106
GSK Investigational Site
Jerusalem, Israel, 91120
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107
GSK Investigational Site
Koranit, Israel, 2018100
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108
GSK Investigational Site
Petah Tikva, Israel, 49100
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109
GSK Investigational Site
Tel Aviv, Israel, 64239
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110
GSK Investigational Site
Ancona, Italy
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111
GSK Investigational Site
Catania, Italy
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112
GSK Investigational Site
Meldola FC, Italy, 47014
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113
GSK Investigational Site
Palermo, Italy, 90127
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114
GSK Investigational Site
Pavia, Italy, 27100
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115
GSK Investigational Site
Pisa, Italy
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116
GSK Investigational Site
Roma, Italy, 00161
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117
GSK Investigational Site
Shibuya-Ku, Tokyo, Japan, 150-8935
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118
GSK Investigational Site
Aichi, Japan, 467-8602
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119
GSK Investigational Site
Ehime, Japan, 790-0024
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120
GSK Investigational Site
Ehime, Japan, 790-8524
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121
GSK Investigational Site
Fukuoka, Japan, 815-8555
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122
GSK Investigational Site
Fukushima, Japan, 960-1295
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123
GSK Investigational Site
Gunma, Japan, 371-8511
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124
GSK Investigational Site
Hyōgo, Japan, 660-8550
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125
GSK Investigational Site
Hyōgo, Japan, 670-8540
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126
GSK Investigational Site
Ibaraki, Japan, 300-0028
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127
GSK Investigational Site
Ishikawa, Japan, 920-8641
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128
GSK Investigational Site
Kanagawa, Japan, 211-8510
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129
GSK Investigational Site
Miyagi, Japan, 983-8520
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130
GSK Investigational Site
Nara, Japan, 632-8552
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131
GSK Investigational Site
Numakunai, Japan, 028-3695
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132
GSK Investigational Site
Osaka, Japan, 589-8511
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133
GSK Investigational Site
Sapporo, Japan, 003-0006
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134
GSK Investigational Site
Suita, Japan, 565-0871
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135
GSK Investigational Site
Tokyo, Japan, 105-8471
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136
GSK Investigational Site
Yamagata, Japan, 990-9585
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137
GSK Investigational Site
Bergen, Norway, 5021
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138
GSK Investigational Site
Lrenskog, Norway, 1470
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139
GSK Investigational Site
Oslo, Norway
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140
GSK Investigational Site
Lodz, Poland, 93-513
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141
GSK Investigational Site
Lublin, Poland, 20-954
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142
GSK Investigational Site
Lublin, Poland
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143
GSK Investigational Site
Warsaw, Poland, 02-781
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144
GSK Investigational Site
Wałbrzych, Poland, 58-309
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145
GSK Investigational Site
Kuils River, South Africa, 7580
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146
GSK Investigational Site
Pretoria, South Africa, 0181
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147
GSK Investigational Site
Hwasun, South Korea, 519-763
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148
GSK Investigational Site
Jeonju, South Korea, 561-712
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149
GSK Investigational Site
Seoul, South Korea, 03080
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150
GSK Investigational Site
Seoul, South Korea, 03722
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151
GSK Investigational Site
Seoul, South Korea, 06351
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152
GSK Investigational Site
Seoul, South Korea, 06591
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153
GSK Investigational Site
Seoul, South Korea, 138-736
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154
GSK Investigational Site
Ulsan, South Korea, 44033
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155
GSK Investigational Site
Badalona, Spain
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156
GSK Investigational Site
Barcelona, Spain, 08035
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157
GSK Investigational Site
Gijón, Spain, 33394
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158
GSK Investigational Site
Madrid, Spain, 28007
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159
GSK Investigational Site
Madrid, Spain, 28041
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160
GSK Investigational Site
Madrid, Spain
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161
GSK Investigational Site
Málaga, Spain, 29010
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162
GSK Investigational Site
Murcia, Spain, 30120
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163
GSK Investigational Site
Salamanca, Spain
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164
GSK Investigational Site
Santander, Spain, 39011
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165
GSK Investigational Site
Valladolid, Spain, 47003
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166
GSK Investigational Site
Kaohsiung City, Taiwan, 807
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167
GSK Investigational Site
Taichung, Taiwan, 407219
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168
GSK Investigational Site
Tainan, Taiwan, 704
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169
GSK Investigational Site
Taipei, Taiwan, 10002
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170
GSK Investigational Site
Taoyuan, Taiwan, 33305
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171
GSK Investigational Site
Samsun, Atakum, Turkey (Türkiye), 55200
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172
GSK Investigational Site
Kocaeli, İzmit, Turkey (Türkiye), 41001
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173
GSK Investigational Site
Ankara, Yenimahalle, Turkey (Türkiye), 06170
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174
GSK Investigational Site
Adana, Turkey (Türkiye), 01330
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175
GSK Investigational Site
Ankara, Turkey (Türkiye), 06680
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176
GSK Investigational Site
Sisli - Istanbul, Turkey (Türkiye), 34381
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177
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
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178
GSK Investigational Site
Middlesbrough, United Kingdom, TS4 3BW
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179
GSK Investigational Site
Oxford, United Kingdom, OX3 7LE
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180
GSK Investigational Site
Plymouth, United Kingdom, PL6 8DH
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181
GSK Investigational Site
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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