Multiple Myeloma Clinical Trial

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Summary

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Capable of giving signed informed consent.
Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment.
Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (mg/dL) (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was >100 days prior to initiating study treatment; No active infection(s).
Adequate organ system functions as defined: Absolute neutrophil count (ANC) >=1.0*10^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x10^9/L; Total bilirubin <=1.5* Upper limit of normal (ULN) (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); ALT <=2.5*ULN; Estimated glomerular filtration rate (eGFR)>=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56 milligram per millimoles [mg/mmol]).
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year when having sexual intercourse with a pregnant woman or of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pomdex).
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a failure rate of <1 percent per year) which includes abstinence, preferably with low user dependency during the intervention period and for 4 months after last dose of study treatment. Arm 2 (pomdex): Due to pomalidomide being a thalidomide analogue risk embryofetal toxicity prescribed under pregnancy preventioncontrolled distribution program, WOCBP participants will be eligible if they commit either abstain continuously from heterosexual sexual intercourse or use two methods reliable birth control (one method that is highly effective), beginning weeks prior initiating treatment pomalidomide, therapy, interruptions continuing at least following discontinuation Two negative tests must obtained therapy. The first test should performed within 10-14 days second 24 hours prescribing And agrees not donate eggs (ova, oocytes) purpose reproduction this period. investigator confirm effectiveness contraceptive method(s) ahead intervention.
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.

Exclusion Criteria:

Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening.
Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention.
Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention.
Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment.
Plasmapheresis within 7 days prior to the first dose of study intervention.
Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease [GvHD]).
Any major surgery within the last 4 weeks.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as described in inclusion criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
Evidence of active mucosal or internal bleeding.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease [including Gilbert's syndrome or asymptomatic gallstones] or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria)
Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. (Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction).
Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the components of the study intervention.
Pregnant or lactating female.
Active infection requiring treatment.
Known human immunodeficiency virus (HIV), unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copiesmL; CD4+ T-cell (CD4+) counts ≥350 cellsuL; No history of AIDS-defining opportunistic infections within the last 12 months.(Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction or overlapping toxicities with belantamab mafodotin other combination products as relevant)
Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment, exclusion of participants with cirrhosis and participants in Japan must test hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb ).
Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: Hepatitis C RNA test negative at Screening and successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks (Hepatitis RNA is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing).
Participants unable to tolerate thromboembolic prophylaxis.
Current corneal epithelial disease except for mild punctate keratopathy.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

338

Study ID:

NCT04162210

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 164 Locations for this study

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GSK Investigational Site
Tucson Arizona, 85715, United States
GSK Investigational Site
Santa Barbara California, 93105, United States
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Pueblo Colorado, 81008, United States
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Plantation Florida, 33322, United States
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Detroit Michigan, 48202, United States
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Omaha Nebraska, 68130, United States
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Las Vegas Nevada, 89169, United States
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Albany New York, 12208, United States
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Lake Success New York, 10042, United States
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Cincinnati Ohio, 45236, United States
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Eugene Oregon, 97401, United States
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Salem Oregon, 97301, United States
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Dallas Texas, 75230, United States
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Dallas Texas, 75231, United States
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Tyler Texas, 75702, United States
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Milwaukee Wisconsin, 53226, United States
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Gosford New South Wales, 2250, Australia
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Liverpool New South Wales, 2170, Australia
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St Leonards New South Wales, 2065, Australia
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Wollongong New South Wales, 2500, Australia
GSK Investigational Site
North Adelaide South Australia, 5006, Australia
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Woodville South Australia, 5011, Australia
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Hobart Tasmania, 7000, Australia
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Clayton Victoria, 3168, Australia
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Fitzroy Victoria, 3065, Australia
GSK Investigational Site
Geelong Victoria, 3220, Australia
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Melbourne Victoria, 3004, Australia
GSK Investigational Site
Nedlands Western Australia, 6009, Australia
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St. Albans , 03021, Australia
GSK Investigational Site
Brugge , 8000, Belgium
GSK Investigational Site
Bruxelles , 1200, Belgium
GSK Investigational Site
Edegem , 2650, Belgium
GSK Investigational Site
Gent , 9000, Belgium
GSK Investigational Site
Jette , 1090, Belgium
GSK Investigational Site
Kortrijk , 8500, Belgium
GSK Investigational Site
Yvoir , 5530, Belgium
GSK Investigational Site
Fortaleza Ceará, 60115, Brazil
GSK Investigational Site
Curitiba Paraná, 03089, Brazil
GSK Investigational Site
Porto Alegre Rio Grande Do Sul, 90035, Brazil
GSK Investigational Site
Porto Alegre Rio Grande Do Sul, 90110, Brazil
GSK Investigational Site
Rio de Janeiro , 21941, Brazil
GSK Investigational Site
Rio de Janeiro , 22793, Brazil
GSK Investigational Site
São Paulo , 01321, Brazil
GSK Investigational Site
São Paulo , 01509, Brazil
GSK Investigational Site
São Paulo , 04537, Brazil
GSK Investigational Site
São Paulo , 05651, Brazil
GSK Investigational Site
Pleven , 5800, Bulgaria
GSK Investigational Site
Plovdiv , 4000, Bulgaria
GSK Investigational Site
Sofia , 01431, Bulgaria
GSK Investigational Site
Sofia , 1000, Bulgaria
GSK Investigational Site
Sofia , 1407, Bulgaria
GSK Investigational Site
Sofia , 1606, Bulgaria
GSK Investigational Site
Edmonton Alberta, T6G 1, Canada
GSK Investigational Site
Guangzhou Guangdong, 51008, China
GSK Investigational Site
Changchun Jilin, 13001, China
GSK Investigational Site
Beijing , 10019, China
GSK Investigational Site
Beijing , 10073, China
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Chengdu , 61004, China
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Hangzhou , 31000, China
GSK Investigational Site
Tianjin , 30002, China
GSK Investigational Site
Tianjin , 30006, China
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Zhengzhou , 45005, China
GSK Investigational Site
Amiens cedex 1 , 80054, France
GSK Investigational Site
Créteil cedex , 94010, France
GSK Investigational Site
Grenoble cedex 9 , 38043, France
GSK Investigational Site
Le Mans , 72015, France
GSK Investigational Site
Limoges cedex , 87042, France
GSK Investigational Site
Montpellier , 34295, France
GSK Investigational Site
Parris Cedex 12 , 75571, France
GSK Investigational Site
Poitiers cedex , 86021, France
GSK Investigational Site
Tuebingen Baden-Wuerttemberg, 72076, Germany
GSK Investigational Site
Ulm Baden-Wuerttemberg, 89081, Germany
GSK Investigational Site
Wuerzburg Bayern, 97080, Germany
GSK Investigational Site
Mainz Rheinland-Pfalz, 55101, Germany
GSK Investigational Site
Berlin , 13125, Germany
GSK Investigational Site
Hamburg , 20246, Germany
GSK Investigational Site
Athens , 10676, Greece
GSK Investigational Site
Athens , 115 2, Greece
GSK Investigational Site
Haidari, Athens , 12462, Greece
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Larisa , 41 11, Greece
GSK Investigational Site
Patra , 26500, Greece
GSK Investigational Site
Thessaloniki , 54007, Greece
GSK Investigational Site
Thessaloniki , 57010, Greece
GSK Investigational Site
Budapest , 1083, Hungary
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Budapest , 1088, Hungary
GSK Investigational Site
Budapest , 1097, Hungary
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Debrecen , 4012, Hungary
GSK Investigational Site
Kaposvár , 7400, Hungary
GSK Investigational Site
Nyiregyhaza , 4400, Hungary
GSK Investigational Site
Catanzaro Calabria, 88100, Italy
GSK Investigational Site
Bologna Emilia-Romagna, 40138, Italy
GSK Investigational Site
Meldola (FC) Emilia-Romagna, 47014, Italy
GSK Investigational Site
Ravenna Emilia-Romagna, 48123, Italy
GSK Investigational Site
Roma Lazio, 00161, Italy
GSK Investigational Site
Brescia Lombardia, 25123, Italy
GSK Investigational Site
Milano Lombardia, 20141, Italy
GSK Investigational Site
Pavia Lombardia, 27100, Italy
GSK Investigational Site
Ancona Marche, 60126, Italy
GSK Investigational Site
San Giovanni Rotondo Puglia, 71013, Italy
GSK Investigational Site
Siena Toscana, 53100, Italy
GSK Investigational Site
Terni Umbria, 05100, Italy
GSK Investigational Site
Milano , 20122, Italy
GSK Investigational Site
Aichi , 467-8, Japan
GSK Investigational Site
Chiba , 277-8, Japan
GSK Investigational Site
Ehime , 790-8, Japan
GSK Investigational Site
Fukushima , 960-1, Japan
GSK Investigational Site
Gifu , 503-8, Japan
GSK Investigational Site
Gunma , 377-0, Japan
GSK Investigational Site
Hokkaido , 060-8, Japan
GSK Investigational Site
Kyoto , 602-8, Japan
GSK Investigational Site
Kyoto , 603-8, Japan
GSK Investigational Site
Osaka , 565-0, Japan
GSK Investigational Site
Saitama , 350-8, Japan
GSK Investigational Site
Tokushima , 770-8, Japan
GSK Investigational Site
Tokyo , 108-8, Japan
GSK Investigational Site
Tokyo , 135-8, Japan
GSK Investigational Site
Tokyo , 150-8, Japan
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Goyang-si, Gyeonggi-Do , 410-7, Korea, Republic of
GSK Investigational Site
Hwasun , 58128, Korea, Republic of
GSK Investigational Site
Incheon , 405-7, Korea, Republic of
GSK Investigational Site
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
GSK Investigational Site
Seoul , 03080, Korea, Republic of
GSK Investigational Site
Seoul , 05505, Korea, Republic of
GSK Investigational Site
Seoul , 06591, Korea, Republic of
GSK Investigational Site
Amersfoort , 3813 , Netherlands
GSK Investigational Site
Rotterdam , 3015 , Netherlands
GSK Investigational Site
Gdansk , 80-95, Poland
GSK Investigational Site
Krakow , 30510, Poland
GSK Investigational Site
Krakow , 31-50, Poland
GSK Investigational Site
Torun , 87-10, Poland
GSK Investigational Site
Warszawa , 02106, Poland
GSK Investigational Site
Ekaterinburg , 62010, Russian Federation
GSK Investigational Site
Kaluga , 24800, Russian Federation
GSK Investigational Site
Kemerovo , 65006, Russian Federation
GSK Investigational Site
Kirov , 61002, Russian Federation
GSK Investigational Site
Krasnoyarsk , 66002, Russian Federation
GSK Investigational Site
Nizhny Novgorod , 60313, Russian Federation
GSK Investigational Site
Novosibirsk , 63008, Russian Federation
GSK Investigational Site
Saint Petersburg , 19734, Russian Federation
GSK Investigational Site
Samara , 44302, Russian Federation
GSK Investigational Site
Sochi , 35405, Russian Federation
GSK Investigational Site
St'Petersburg , 19102, Russian Federation
GSK Investigational Site
Syktyvkar , 16790, Russian Federation
GSK Investigational Site
Tula , 30005, Russian Federation
GSK Investigational Site
Yaroslavl , 15006, Russian Federation
GSK Investigational Site
Badalona , 08916, Spain
GSK Investigational Site
Barcelona , 08036, Spain
GSK Investigational Site
Hospitalet de Llobregat (Barcelona) , 08908, Spain
GSK Investigational Site
Malaga , 29004, Spain
GSK Investigational Site
Pamplona , 31008, Spain
GSK Investigational Site
Pozuelo De Alarcón/Madrid , 28223, Spain
GSK Investigational Site
Salamanca , 37007, Spain
GSK Investigational Site
Santiago de Compostela , 15706, Spain
GSK Investigational Site
Valencia , 46017, Spain
GSK Investigational Site
Airdrie Lanarkshire, ML6 0, United Kingdom
GSK Investigational Site
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
GSK Investigational Site
Dundee , DD1 9, United Kingdom
GSK Investigational Site
Edinburgh , EH4 2, United Kingdom
GSK Investigational Site
London , EC1 7, United Kingdom
GSK Investigational Site
London , W12 0, United Kingdom
GSK Investigational Site
Manchester , M20 4, United Kingdom
GSK Investigational Site
Nottingham , NG5 1, United Kingdom
GSK Investigational Site
Oxford , OX3 7, United Kingdom
GSK Investigational Site
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

338

Study ID:

NCT04162210

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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