Phase
Condition
Multiple Myeloma
Cancer/tumors
Leukemia
Treatment
Pomalidomide
Belantamab mafodotin
Bortezomib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 InternationalMyeloma 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 alenalidomide-containing regimen and must have documented disease progression duringor after their most recent therapy. (Participants treated with lenalidomide ≥10 mgdaily for at least 2 consecutive cycles are eligible).
Must have at least 1 aspect of measurable disease defined as one of the following;
Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]),or
Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L)and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
Have undergone autologous stem cell transplant (ASCT) or are considered transplantineligible. Participants with a history of ASCT are eligible for study participationprovided the following eligibility criteria are met: a. ASCT was >100 days prior tothe first dose of study medication. b. No active bacterial, viral, or fungalinfection(s) present
All prior treatment-related toxicities (defined by National Cancer Institute CommonTerminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less thanor 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 contraceptiverequirements.
Exclusion
Exclusion Criteria:
Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy,organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skinchanges (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 studydrug; prior treatment with a monoclonal antibody drug within 30 days of receivingthe 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; participantexperienced progressive disease during treatment, or within 60 days of completingtreatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twiceweekly).
Evidence of cardiovascular risk including any of the following;
Evidence of current clinically significant untreated arrhythmias, includingclinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
Recent history within (3 months of screening) of myocardial infarction, acutecoronary syndromes (including unstable angina), coronary angioplasty, orstenting or bypass grafting .
Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
Uncontrolled hypertension.
Any major surgery within the last 4 weeks.
Previous or concurrent invasive malignancy other than multiple myeloma, except:
The disease must be considered medically stable for at least 2 years; or
The participant must not be receiving active therapy, other than hormonaltherapy for this disease.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction tobelantamab mafodotin or drugs chemically related to belantamab mafodotin, or any ofthe components of the study treatment.
Evidence of active mucosal or internal bleeding.
Cirrhosis or current unstable liver or biliary disease per investigator assessmentdefined 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 orhepatitis C will be excluded unless the protocol-defined criteria are met.
Presence of active renal conditions (such as infection, severe renal impairmentrequiring dialysis or any other condition that could affect participant's safety).
Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior torandomization 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-thromboticprophylaxis.
Current corneal disease except for mild punctate keratopathy.
Any serious and/or unstable pre-existing medical, psychiatric disorder or otherconditions (including laboratory abnormalities) that could interfere withparticipant's safety, obtaining informed consent or compliance to the studyprocedures.
Pregnant or lactating female.
Study Design
Connect with a study center
GSK Investigational Site
Canberra, Australian Capital Territory 2605
AustraliaSite Not Available
GSK Investigational Site
Garran, Australian Capital Territory 2605
AustraliaSite Not Available
GSK Investigational Site
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
GSK Investigational Site
Gosford, New South Wales 2250
AustraliaSite Not Available
GSK Investigational Site
Gosford NSW, New South Wales 2250
AustraliaSite Not Available
GSK Investigational Site
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
GSK Investigational Site
Randwick, New South Wales 2031
AustraliaSite Not Available
GSK Investigational Site
Wollongong, New South Wales 2500
AustraliaSite Not Available
GSK Investigational Site
Benowa, Queensland 4217
AustraliaSite Not Available
GSK Investigational Site
South Brisbane, Queensland 4101
AustraliaSite Not Available
GSK Investigational Site
Adelaide, South Australia 5000
AustraliaSite Not Available
GSK Investigational Site
Fitzroy, Victoria 3065
AustraliaSite Not Available
GSK Investigational Site
Geelong, Victoria 3220
AustraliaSite Not Available
GSK Investigational Site
Heidelberg, Victoria 3084
AustraliaSite Not Available
GSK Investigational Site
Malvern, Victoria 3144
AustraliaSite Not Available
GSK Investigational Site
Nedlands, Western Australia 6009
AustraliaSite Not Available
GSK Investigational Site
Curitiba, 01308-050
BrazilSite Not Available
GSK Investigational Site
Joinville, 89201-260
BrazilSite Not Available
GSK Investigational Site
Porto Alegre, 90035-903
BrazilSite Not Available
GSK Investigational Site
Rio de Janeiro, 22793-080
BrazilSite Not Available
GSK Investigational Site
SAo Paulo, 04537-081
BrazilSite Not Available
GSK Investigational Site
São Paulo, 01509-900
BrazilSite Not Available
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
GSK Investigational Site
Montreal, H2X 0A9
CanadaSite Not Available
GSK Investigational Site
Guangzhou, Guangdong 510060
ChinaSite Not Available
GSK Investigational Site
Shenzhen, Guangdong 518029
ChinaSite Not Available
GSK Investigational Site
Wuhan, Hubei 430022
ChinaSite Not Available
GSK Investigational Site
Xuzhou, Jiangsu 221004
ChinaSite Not Available
GSK Investigational Site
Beijing, 100191
ChinaSite Not Available
GSK Investigational Site
Changchun, 130012
ChinaSite Not Available
GSK Investigational Site
Changsha, 410013
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310003
ChinaSite Not Available
GSK Investigational Site
Jiangsu, 221004
ChinaSite Not Available
GSK Investigational Site
Nanchang, 330006
ChinaSite Not Available
GSK Investigational Site
Shenyang, 110004
ChinaSite Not Available
GSK Investigational Site
Tianjin, 300020
ChinaSite Not Available
GSK Investigational Site
Brno, 62500
CzechiaSite Not Available
GSK Investigational Site
Hradec Kralove, 50333
CzechiaSite Not Available
GSK Investigational Site
Praha 2, 12808
CzechiaSite Not Available
GSK Investigational Site
Dijon cedex, 21079
FranceSite Not Available
GSK Investigational Site
Marseille, 13273
FranceSite Not Available
GSK Investigational Site
Marseille Cedex 9, 13273
FranceSite Not Available
GSK Investigational Site
Périgueux cedex, 24019
FranceSite Not Available
GSK Investigational Site
Toulouse cedex 9, 31059
FranceSite Not Available
GSK Investigational Site
Vandeouvre-les-Nancy, 54500
FranceSite Not Available
GSK Investigational Site
Vandoeuvre-Les-Nancy, 54511
FranceSite Not Available
GSK Investigational Site
Vanduvre-lEs-Nancy, 54511
FranceSite Not Available
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg 69120
GermanyActive - Recruiting
GSK Investigational Site
Leipzig, Sachsen 04103
GermanySite Not Available
GSK Investigational Site
Jena, Thueringen 07747
GermanySite Not Available
GSK Investigational Site
Berlin, 12351
GermanySite Not Available
GSK Investigational Site
Hamburg, 20246
GermanySite Not Available
GSK Investigational Site
Mainz, 55131
GermanySite Not Available
GSK Investigational Site
Tuebingen, 72076
GermanySite Not Available
GSK Investigational Site
Wuerzburg, 97080
GermanySite Not Available
GSK Investigational Site
Athens, 10676
GreeceSite Not Available
GSK Investigational Site
Ioannina, 45 500
GreeceSite Not Available
GSK Investigational Site
Larisa, 41110
GreeceSite Not Available
GSK Investigational Site
Rio/Patras, 26504
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 57010
GreeceSite Not Available
GSK Investigational Site
Ashdod, 7747629
IsraelSite Not Available
GSK Investigational Site
Beer-Sheva, 84101
IsraelSite Not Available
GSK Investigational Site
Haifa, 3109601
IsraelSite Not Available
GSK Investigational Site
Jerusalem, 91031
IsraelSite Not Available
GSK Investigational Site
Kfar Saba, 4428164
IsraelSite Not Available
GSK Investigational Site
Nahariya, 2633737
IsraelSite Not Available
GSK Investigational Site
Petach Tikva, 49100
IsraelSite Not Available
GSK Investigational Site
Petach-Tikva, 4941492
IsraelSite Not Available
GSK Investigational Site
Ramat Gan, 52621
IsraelSite Not Available
GSK Investigational Site
Tel Aviv, 6423906
IsraelSite Not Available
GSK Investigational Site
San Giovanni Rotondo, Puglia 71013
ItalySite Not Available
GSK Investigational Site
Bologna, 40138
ItalySite Not Available
GSK Investigational Site
Milano, 20122
ItalySite Not Available
GSK Investigational Site
Pavia, 27100
ItalySite Not Available
GSK Investigational Site
Roma, 00161
ItalySite Not Available
GSK Investigational Site
Aichi, 467-8602
JapanSite Not Available
GSK Investigational Site
Chiba, 296-8602
JapanSite Not Available
GSK Investigational Site
Ehime, 790-8524
JapanSite Not Available
GSK Investigational Site
Fukuoka, 810-8563
JapanSite Not Available
GSK Investigational Site
Fukushima, 960-1295
JapanSite Not Available
GSK Investigational Site
Gunma, 377-0280
JapanSite Not Available
GSK Investigational Site
Hiroshima, 720-0001
JapanSite Not Available
GSK Investigational Site
Hokkaido, 060-8648
JapanSite Not Available
GSK Investigational Site
Iwate, 028-3695
JapanSite Not Available
GSK Investigational Site
Kumamoto, 860-0008
JapanSite Not Available
GSK Investigational Site
Kyoto, 602-8566
JapanSite Not Available
GSK Investigational Site
Okayama, 701-1192
JapanSite Not Available
GSK Investigational Site
Osaka, 565-0871
JapanSite Not Available
GSK Investigational Site
Saitama, 350-0495
JapanSite Not Available
GSK Investigational Site
Tokushima, 770-8539
JapanSite Not Available
GSK Investigational Site
Tokyo, 108-8639
JapanSite Not Available
GSK Investigational Site
Tottori, 683-8504
JapanSite Not Available
GSK Investigational Site
Yamagata, 990-9585
JapanSite Not Available
GSK Investigational Site
Busan, 49241
Korea, Republic ofSite Not Available
GSK Investigational Site
Gyeonggi-do, 10408
Korea, Republic ofSite Not Available
GSK Investigational Site
Hwasun, 58128
Korea, Republic ofSite Not Available
GSK Investigational Site
Hwasun-gun, Jeollanam-do, 58128
Korea, Republic ofSite Not Available
GSK Investigational Site
Incheon, 405-760
Korea, Republic ofSite Not Available
GSK Investigational Site
Inchon, 21565
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
GSK Investigational Site
Ulsan, 44033
Korea, Republic ofSite Not Available
GSK Investigational Site
Auckland, 2025
New ZealandSite Not Available
GSK Investigational Site
Christchurch, 8011
New ZealandSite Not Available
GSK Investigational Site
Dunedin, 9016
New ZealandSite Not Available
GSK Investigational Site
Grafton, 1023
New ZealandSite Not Available
GSK Investigational Site
Grafton, Auckland, 1023
New ZealandSite Not Available
GSK Investigational Site
Hamilton, 3204
New ZealandSite Not Available
GSK Investigational Site
Takapuna Auckland, 622
New ZealandSite Not Available
GSK Investigational Site
Tauranga, 3143
New ZealandSite Not Available
GSK Investigational Site
Bydgoszcz, 85-168
PolandSite Not Available
GSK Investigational Site
Gdansk, 80-214
PolandSite Not Available
GSK Investigational Site
Krakow, 31-501
PolandSite Not Available
GSK Investigational Site
Lodz, 93-513
PolandSite Not Available
GSK Investigational Site
Lublin, 20-090
PolandSite Not Available
GSK Investigational Site
Wroclaw, 50-367
PolandSite Not Available
GSK Investigational Site
Kaluga, 248007
Russian FederationSite Not Available
GSK Investigational Site
Moscow, 125284
Russian FederationSite Not Available
GSK Investigational Site
Nizhniy Novgorod, 603126
Russian FederationSite Not Available
GSK Investigational Site
Novosibirsk, 630087
Russian FederationSite Not Available
GSK Investigational Site
Omsk, 644013
Russian FederationSite Not Available
GSK Investigational Site
Saint Petersburg, 197341
Russian FederationSite Not Available
GSK Investigational Site
Samara, 443099
Russian FederationSite Not Available
GSK Investigational Site
Sochi, 354057
Russian FederationSite Not Available
GSK Investigational Site
St Petersburg, 191024
Russian FederationSite Not Available
GSK Investigational Site
St'Petersburg, 191024
Russian FederationSite Not Available
GSK Investigational Site
St-Petersburg, 194291
Russian FederationSite Not Available
GSK Investigational Site
St. Petersburg, 197 089
Russian FederationSite Not Available
GSK Investigational Site
Tula, 300053
Russian FederationSite Not Available
GSK Investigational Site
Móstoles, Madrid 28933
SpainSite Not Available
GSK Investigational Site
Badalona, ?08036
SpainSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Gijon, 33204
SpainSite Not Available
GSK Investigational Site
Hospitalet de Llobregat (Barcelona), 08908
SpainSite Not Available
GSK Investigational Site
L'Hospitalet De Llobrega, 08908
SpainSite Not Available
GSK Investigational Site
MOstoles Madrid, 28933
SpainSite Not Available
GSK Investigational Site
Madrid, 28027
SpainSite Not Available
GSK Investigational Site
Murcia, 30008
SpainSite Not Available
GSK Investigational Site
Palma de Mallorca, 07120
SpainSite Not Available
GSK Investigational Site
Pamplona, 31008
SpainSite Not Available
GSK Investigational Site
PamplonaNavarra, 31008
SpainSite Not Available
GSK Investigational Site
Pozuelo De AlarcOn Madr, 28223
SpainSite Not Available
GSK Investigational Site
Pozuelo De Alarcón/Madrid, 28223
SpainSite Not Available
GSK Investigational Site
Salamanca, 37007
SpainSite Not Available
GSK Investigational Site
Sevilla, 41013
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Ankara, 6560
TurkeySite Not Available
GSK Investigational Site
Istanbul, 34214
TurkeySite Not Available
GSK Investigational Site
Izmir, 35100
TurkeySite Not Available
GSK Investigational Site
Kocaeli, 41400
TurkeySite Not Available
GSK Investigational Site
Mersin, 33343
TurkeySite Not Available
GSK Investigational Site
Samsun, 55139
TurkeySite Not Available
GSK Investigational Site
Airdrie, Lanarkshire ML6 0JS
United KingdomSite Not Available
GSK Investigational Site
Stoke-on-Trent, Staffordshire ST4 6QG
United KingdomSite Not Available
GSK Investigational Site
Bournemouth, BH7 7DW
United KingdomSite Not Available
GSK Investigational Site
London, W12 0HS
United KingdomSite Not Available
GSK Investigational Site
Plymouth, PL6 8D8
United KingdomSite Not Available
GSK Investigational Site
Southampton, SO16 6YD
United KingdomSite Not Available
GSK Investigational Site
Stoke on Trent, ST4 6QG
United KingdomSite Not Available
GSK Investigational Site
Sutton, SM2 5PT
United KingdomSite Not Available
GSK Investigational Site
Tucson, Arizona 85712
United StatesSite Not Available
GSK Investigational Site
Denver, Colorado 80218
United StatesSite Not Available
GSK Investigational Site
Fort Myers, Florida 33901
United StatesSite Not Available
GSK Investigational Site
New Port Richey, Florida 34655
United StatesSite Not Available
GSK Investigational Site
Pembroke Pines, Florida 33024
United StatesSite Not Available
GSK Investigational Site
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02215
United StatesSite Not Available
GSK Investigational Site
Kansas City, Missouri 64132
United StatesSite Not Available
GSK Investigational Site
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
GSK Investigational Site
Nashville, Tennessee 37203
United StatesSite Not Available
GSK Investigational Site
Seattle, Washington 98109
United StatesSite Not Available
GSK Investigational Site
Spokane, Washington 99202
United StatesSite Not Available
GSK Investigational Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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