Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
NCT ID: NCT04246047
Last Updated: 2024-10-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
494 participants
INTERVENTIONAL
2020-05-07
2026-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Bortezomib
Proteasome Inhibitor
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Daratumumab and Bortezomib plus Dexamethasone (Arm B)
Daratumumab
Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
Bortezomib
Proteasome Inhibitor
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Interventions
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Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Daratumumab
Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
Bortezomib
Proteasome Inhibitor
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Eligibility Criteria
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Inclusion 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;
1. Urine M-protein excretion \>=200 mg per 24-hour, or
2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
3. 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Yuma, Arizona, United States
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Denver, Colorado, United States
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Fairfield, Connecticut, United States
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Kansas City, Kansas, United States
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Tyler, Texas, United States
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Roanoke, Virginia, United States
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Camperdown, New South Wales, Australia
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Waratah, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Benowa, Queensland, Australia
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Herston, Queensland, Australia
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Ashford, South Australia, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Roeselare, , Belgium
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Florianópolis, , Brazil
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Joinville, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Nanjing, , China
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Shenyang, , China
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Suzhou, , China
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Tianjin, , China
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Zhengzhou, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Amiens, , France
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Caen, , France
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Nice, , France
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Paris, , France
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Rennes, , France
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Cologne, , Germany
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Düsseldorf, , Germany
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Jena, , Germany
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München, , Germany
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Ulm, , Germany
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Würzburg, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Bergamo, , Italy
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Bologna, , Italy
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Brescia, , Italy
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Catania, , Italy
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Meldola FC, , Italy
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Milan, , Italy
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Ravenna, , Italy
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Roma, , Italy
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Siena, , Italy
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Torino, , Italy
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Aichi, , Japan
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Aichi, , Japan
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Aomori, , Japan
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Ehime, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Gifu, , Japan
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Gunma, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kochi, , Japan
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Nagano, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Shizuoka, , Japan
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Dordrecht, , Netherlands
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Groningen, , Netherlands
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Takapuna Auckland, , New Zealand
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Wellington, , New Zealand
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Chorzów, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Nowy Sącz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Ufa, , Russia
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Pusan, , South Korea
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Seongnam-si Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Ulsan, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Cáceres, , Spain
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Gijón, , Spain
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L'Hospitalet de Llobrega, , Spain
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Madrid, , Spain
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Madrid, , Spain
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MOstoles Madrid, , Spain
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Murcia, , Spain
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PamplonaNavarra, , Spain
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Pozuelo de AlarcOn Madr, , Spain
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Salamanca, , Spain
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Bournemouth, , United Kingdom
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Cardiff, , United Kingdom
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Dundee, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev VI, Lacerda MP, Martinez GA, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria VTM, Dimopoulos MA. Modification of Belantamab Mafodotin Dosing to Balance Efficacy and Tolerability in the DREAMM-7 and DREAMM-8 Trials. Blood Adv. 2025 Aug 5:bloodadvances.2025016949. doi: 10.1182/bloodadvances.2025016949. Online ahead of print.
Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Martinez GA, Sureda Balari A, Sandhu I, Cerchione C, Ganly P, Dimopoulos MA, Fu C, Garg M, Abdallah AO, Gatt ME, Oriol Rocafiguera A, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Ficek J, Mantero A, Pirooz N, Varghese S, Lee J, McKeown A, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Mukhopadhyay P, Nielsen J, Opalinska J, Mateos MV; DREAMM-7 study investigators. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Aug;26(8):1067-1080. doi: 10.1016/S1470-2045(25)00330-4. Epub 2025 Jul 15.
Hungria V, Hus M, Fu C, Zherebtsova V, Ward C, Ho PJ, Mikulski D, Muronova L, Cerchione C, Loubert A, Bunod L, M'Hari M, Pirooz N, Rogers R, Lin CP, Roy-Ghanta S, Opalinska JB, Purser M, McKeown A, McNamara S, Baig H, Eccersley L, Pompilus F, Mateos MV; DREAMM-7 trial study group. Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Aug;12(8):e599-e610. doi: 10.1016/S2352-3026(25)00163-2. Epub 2025 Jul 15.
Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Ribas de Almeida AC, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Aparecida Martinez G, Sureda Balari AM, Sandhu I, Cerchione C, Ganly P, Dimopoulos M, Fu C, Garg M, Abdallah AO, Oriol A, Gatt ME, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Pirooz N, McKeown A, McNamara S, Zhou X, Nichols M, Lewis E, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Opalinska J, Mateos MV; DREAMM-7 Investigators. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003993-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
207503
Identifier Type: -
Identifier Source: org_study_id
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