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 Full Description

Full Description

Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.

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:

575

Study ID:

NCT04246047

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 152 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
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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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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, 88034, 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
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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
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Changchun Jilin, 13001, China
GSK Investigational Site
Jianan Shandong, 25001, China
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Hangzhou Zhejiang, 31000, China
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Beijing , 10002, China
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Beijing , 10004, China
GSK Investigational Site
Beijing , 10019, China
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GuangZhou , 51051, China
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Jiang Su Province , 21500, China
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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
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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
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Muenchen Bayern, 81377, Germany
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Wuerzburg Bayern, 97080, Germany
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Duesseldorf Nordrhein-Westfalen, 40225, Germany
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Koeln Nordrhein-Westfalen, 50937, Germany
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Jena Thueringen, 07747, Germany
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Alexandroupolis , 68 10, Greece
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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
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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
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Aichi , 446-8, Japan
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Aichi , 467-8, Japan
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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
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Fukushima , 960-1, Japan
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Gifu , 503-8, Japan
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Gunma , 377-0, Japan
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Hokkaido , 060-8, Japan
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Hyogo , 650-0, Japan
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Hyogo , 670-8, Japan
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Kanagawa , 221-0, Japan
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Kanagawa , 247-8, Japan
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Kochi , 781-8, Japan
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Kyoto , 602-8, Japan
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Nagano , 392-8, Japan
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Okayama , 701-1, Japan
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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
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Seoul , 06351, Korea, Republic of
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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
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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
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Poznan , 60-56, Poland
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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
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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
Cáceres , 10003, Spain
GSK Investigational Site
Gijón , 33394, Spain
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Hospitalet de Llobregat (Barcelona) , 08908, Spain
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Madrid , 28007, Spain
GSK Investigational Site
Murcia , 30008, Spain
GSK Investigational Site
Móstoles , 28933, Spain
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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
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Bournemouth , BH7 7, United Kingdom
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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:

575

Study ID:

NCT04246047

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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