Multiple Myeloma Clinical Trial

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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;

Urine M-protein excretion >=200 mg per 24-hour, or
Serum M-protein concentration >=0.5 grams per deciliter (g/dL), or
Serum free light chain (FLC) assay: involved FLC level >=10 mg per dL (>=100 mg per liter) and an abnormal serum free light chain ratio (<0.26 or >1.65).
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:

Intolerant to daratumumab.
Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
Prior allogenic stem cell transplant.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
Corneal epithelial disease.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

571

Study ID:

NCT04246047

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 151 Locations for this study

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GSK Investigational Site
Yuma Arizona, 85364, United States
GSK Investigational Site
Denver Colorado, 80218, United States
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Westwood Kansas, 66205, United States
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Cincinnati Ohio, 45242, United States
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Tyler Texas, 75702, United States
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Roanoke Virginia, 24014, United States
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Camperdown New South Wales, 2050, Australia
GSK Investigational Site
Liverpool New South Wales, 2170, Australia
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St Leonards New South Wales, 2065, Australia
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Waratah New South Wales, 2298, Australia
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Wollongong New South Wales, 2500, Australia
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Benowa Queensland, 4217, Australia
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Herston Queensland, 4029, Australia
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Kurralta Park South Australia, 5037, Australia
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Box Hill Victoria, 3128, Australia
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Heidelberg Victoria, 3084, Australia
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Melbourne Victoria, 3004, Australia
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Murdoch Western Australia, 6150, Australia
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Nedlands Western Australia, 6009, Australia
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Brussel , 1090, Belgium
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Bruxelles , 1200, Belgium
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Gent , 9000, Belgium
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Roeselare , 8800, Belgium
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Natal Rio Grande Do Norte, 59075, Brazil
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Porto Alegre Rio Grande Do Sul, 90035, Brazil
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Florianopolis Santa Catarina, 88020, Brazil
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Joinville Santa Catarina, 89201, Brazil
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Rio de Janeiro , 22775, Brazil
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São Paulo , 04537, Brazil
GSK Investigational Site
São Paulo , 05403, Brazil
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Edmonton Alberta, T6G 1, Canada
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London Ontario, N6A 5, Canada
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Québec Ontario, G1J 1, Canada
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Toronto Ontario, M4N 3, Canada
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Montréal Quebec, H4J 1, Canada
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Guangzhou Guangdong, 51006, China
GSK Investigational Site
Nanjing Jiangsu, 21000, China
GSK Investigational Site
Changchun Jilin, 13001, China
GSK Investigational Site
Jianan Shandong, 25001, China
GSK Investigational Site
Hangzhou Zhejiang, 31000, China
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Beijing , 10002, China
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Beijing , 10004, China
GSK Investigational Site
Beijing , 10019, China
GSK Investigational Site
GuangZhou , 51051, China
GSK Investigational Site
Jiang Su Province , 21500, China
GSK Investigational Site
Shenyang , 11000, China
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Tianjin , 30002, China
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Tianjin , 30005, China
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Wuhan , 43002, China
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Zhengzhou , 45005, China
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Brno , 625 0, Czechia
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Hradec Kralove , 500 0, Czechia
GSK Investigational Site
Ostrava , 708 5, Czechia
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Praha 2 , 128 0, Czechia
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Amiens cedex 1 , 80054, France
GSK Investigational Site
Caen cedex 9 , 14033, France
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Nice , 06200, France
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Paris cedex 13 , 75651, France
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Rennes cedex 9 , 35033, France
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Ulm Baden-Wuerttemberg, 89081, Germany
GSK Investigational Site
Muenchen Bayern, 81377, Germany
GSK Investigational Site
Wuerzburg Bayern, 97080, Germany
GSK Investigational Site
Duesseldorf Nordrhein-Westfalen, 40225, Germany
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Koeln Nordrhein-Westfalen, 50937, Germany
GSK Investigational Site
Jena Thueringen, 07747, Germany
GSK Investigational Site
Alexandroupolis , 68 10, Greece
GSK Investigational Site
Athens , 11528, Greece
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Thessaloniki , 54007, Greece
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Jerusalem , 91120, Israel
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Kfar Saba , 44281, Israel
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Tel Aviv , 64239, Israel
GSK Investigational Site
Tel Hashomer , 52621, Israel
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Bologna Emilia-Romagna, 40138, Italy
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Meldola Emilia-Romagna, 47014, Italy
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Ravenna Emilia-Romagna, 48123, Italy
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Roma Lazio, 00168, Italy
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Bergamo Lombardia, 24127, Italy
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Brescia Lombardia, 25123, Italy
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Milano Lombardia, 20133, Italy
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Torino Piemonte, 10126, Italy
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Catania Sicilia, 95123, Italy
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Siena Toscana, 53100, Italy
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Aichi , 441-8, Japan
GSK Investigational Site
Aichi , 446-8, Japan
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Aichi , 467-8, Japan
GSK Investigational Site
Aomori , 030-8, Japan
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Chiba , 296-8, Japan
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Ehime , 790-8, Japan
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Fukuoka , 806-8, Japan
GSK Investigational Site
Fukuoka , 807-8, Japan
GSK Investigational Site
Fukuoka , 810-8, Japan
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Fukuoka , 815-8, Japan
GSK Investigational Site
Fukushima , 960-1, Japan
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Gifu , 503-8, Japan
GSK Investigational Site
Gunma , 377-0, Japan
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Hokkaido , 060-8, Japan
GSK Investigational Site
Hyogo , 670-8, Japan
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Kanagawa , 221-0, Japan
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Kanagawa , 247-8, Japan
GSK Investigational Site
Kochi , 781-8, Japan
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Kyoto , 602-8, Japan
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Nagano , 392-8, Japan
GSK Investigational Site
Okayama , 701-1, Japan
GSK Investigational Site
Osaka , 530-0, Japan
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Osaka , 545-8, Japan
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Shizuoka , 411-8, Japan
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Busan , 49241, Korea, Republic of
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Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
GSK Investigational Site
Seoul , 06351, Korea, Republic of
GSK Investigational Site
Seoul , 06591, Korea, Republic of
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Ulsan , 44033, Korea, Republic of
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Dordrecht , 3318 , Netherlands
GSK Investigational Site
Groningen , 9713 , Netherlands
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Christchurch , 8011, New Zealand
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Dunedin , 9054, New Zealand
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Newtown , 6021, New Zealand
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Takapuna, Auckland , 1309, New Zealand
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Chorzow , 41-50, Poland
GSK Investigational Site
Krakow , 30510, Poland
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Lodz , 93-51, Poland
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Lublin , 20-08, Poland
GSK Investigational Site
Lublin , 20-09, Poland
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Nowy Sacz , 33-30, Poland
GSK Investigational Site
Poznan , 60-56, Poland
GSK Investigational Site
Warszawa , 02-78, Poland
GSK Investigational Site
Moscow , 12528, Russian Federation
GSK Investigational Site
Nizhniy Novgorod , 60312, Russian Federation
GSK Investigational Site
Novosibirsk , 63008, Russian Federation
GSK Investigational Site
Samara , 44302, Russian Federation
GSK Investigational Site
Saratov , 41002, Russian Federation
GSK Investigational Site
St'Petersburg , 19102, Russian Federation
GSK Investigational Site
St. Petersburg , 197 0, Russian Federation
GSK Investigational Site
Ufa , 45008, Russian Federation
GSK Investigational Site
Badalona , 08916, Spain
GSK Investigational Site
Barcelona , 08035, Spain
GSK Investigational Site
Barcelona , 08908, Spain
GSK Investigational Site
Cáceres , 10003, Spain
GSK Investigational Site
Gijón , 33394, Spain
GSK Investigational Site
Madrid , 28007, Spain
GSK Investigational Site
Murcia , 30008, Spain
GSK Investigational Site
Móstoles , 28933, 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
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
GSK Investigational Site
Sutton Surrey, SM2 5, United Kingdom
GSK Investigational Site
Bournemouth , BH7 7, United Kingdom
GSK Investigational Site
Cardiff , CF14 , United Kingdom
GSK Investigational Site
Dundee , DD1 9, United Kingdom
GSK Investigational Site
Leicester , LE1 5, United Kingdom
GSK Investigational Site
London , W12 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

571

Study ID:

NCT04246047

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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