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.
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.
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There are 151 Locations for this study
Yuma Arizona, 85364, United States
Denver Colorado, 80218, United States
Westwood Kansas, 66205, United States
Cincinnati Ohio, 45242, United States
Tyler Texas, 75702, United States
Roanoke Virginia, 24014, United States
Camperdown New South Wales, 2050, Australia
Liverpool New South Wales, 2170, Australia
St Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
Benowa Queensland, 4217, Australia
Herston Queensland, 4029, Australia
Kurralta Park South Australia, 5037, Australia
Box Hill Victoria, 3128, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Brussel , 1090, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Roeselare , 8800, Belgium
Natal Rio Grande Do Norte, 59075, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Florianopolis Santa Catarina, 88034, Brazil
Joinville Santa Catarina, 89201, Brazil
Rio de Janeiro , 22775, Brazil
São Paulo , 04537, Brazil
São Paulo , 05403, Brazil
Edmonton Alberta, T6G 1, Canada
London Ontario, N6A 5, Canada
Québec Ontario, G1J 1, Canada
Toronto Ontario, M4N 3, Canada
Montréal Quebec, H4J 1, Canada
Guangzhou Guangdong, 51006, China
Nanjing Jiangsu, 21000, China
Changchun Jilin, 13001, China
Jianan Shandong, 25001, China
Hangzhou Zhejiang, 31000, China
Beijing , 10002, China
Beijing , 10004, China
Beijing , 10019, China
GuangZhou , 51051, China
Jiang Su Province , 21500, China
Shenyang , 11000, China
Tianjin , 30002, China
Tianjin , 30005, China
Wuhan , 43002, China
Zhengzhou , 45005, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Praha 2 , 128 0, Czechia
Amiens cedex 1 , 80054, France
Caen cedex 9 , 14033, France
Nice , 06200, France
Paris cedex 13 , 75651, France
Rennes cedex 9 , 35033, France
Ulm Baden-Wuerttemberg, 89081, Germany
Muenchen Bayern, 81377, Germany
Wuerzburg Bayern, 97080, Germany
Duesseldorf Nordrhein-Westfalen, 40225, Germany
Koeln Nordrhein-Westfalen, 50937, Germany
Jena Thueringen, 07747, Germany
Alexandroupolis , 68 10, Greece
Athens , 11528, Greece
Thessaloniki , 54007, Greece
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Tel Aviv , 64239, Israel
Tel Hashomer , 52621, Israel
Bologna Emilia-Romagna, 40138, Italy
Meldola Emilia-Romagna, 47014, Italy
Ravenna Emilia-Romagna, 48123, Italy
Roma Lazio, 00168, Italy
Bergamo Lombardia, 24127, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20133, Italy
Torino Piemonte, 10126, Italy
Catania Sicilia, 95123, Italy
Siena Toscana, 53100, Italy
Aichi , 441-8, Japan
Aichi , 446-8, Japan
Aichi , 467-8, Japan
Aomori , 030-8, Japan
Chiba , 296-8, Japan
Ehime , 790-8, Japan
Fukuoka , 806-8, Japan
Fukuoka , 807-8, Japan
Fukuoka , 810-8, Japan
Fukuoka , 815-8, Japan
Fukushima , 960-1, Japan
Gifu , 503-8, Japan
Gunma , 377-0, Japan
Hokkaido , 060-8, Japan
Hyogo , 670-8, Japan
Kanagawa , 221-0, Japan
Kanagawa , 247-8, Japan
Kochi , 781-8, Japan
Kyoto , 602-8, Japan
Nagano , 392-8, Japan
Okayama , 701-1, Japan
Osaka , 530-0, Japan
Osaka , 545-8, Japan
Shizuoka , 411-8, Japan
Busan , 49241, Korea, Republic of
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Dordrecht , 3318 , Netherlands
Groningen , 9713 , Netherlands
Christchurch , 8011, New Zealand
Dunedin , 9054, New Zealand
Newtown , 6021, New Zealand
Takapuna, Auckland , 1309, New Zealand
Chorzow , 41-50, Poland
Krakow , 30510, Poland
Lodz , 93-51, Poland
Lublin , 20-08, Poland
Lublin , 20-09, Poland
Nowy Sacz , 33-30, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Moscow , 12528, Russian Federation
Nizhniy Novgorod , 60312, Russian Federation
Novosibirsk , 63008, Russian Federation
Samara , 44302, Russian Federation
Saratov , 41002, Russian Federation
St'Petersburg , 19102, Russian Federation
St. Petersburg , 197 0, Russian Federation
Ufa , 45008, Russian Federation
Badalona , 08916, Spain
Barcelona , 08035, Spain
Cáceres , 10003, Spain
Gijón , 33394, Spain
Hospitalet de Llobregat (Barcelona) , 08908, Spain
Madrid , 28007, Spain
Murcia , 30008, Spain
Móstoles , 28933, Spain
Pamplona , 31008, Spain
Pozuelo De Alarcón/Madrid , 28223, Spain
Salamanca , 37007, Spain
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Bournemouth , BH7 7, United Kingdom
Cardiff , CF14 , United Kingdom
Dundee , DD1 9, United Kingdom
Leicester , LE1 5, United Kingdom
London , W12 0, United Kingdom
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