A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM) (DREAMM-10)

April 17, 2026 updated by: GlaxoSmithKline

A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Capital Federal, Argentina, C1426ANZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paola Ochoa
      • Ciudad Autonoma de Buenos Aire, Argentina, 1414
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanesa Caruso
      • Córdoba, Argentina
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Salinas
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herman Perroud
      • Viedma, Argentina, R8500ACE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rubén Kowalyszyn
  • Australia
      • Fitzroy, Australia
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hang Quach
        • Contact:
        • Contact:
      • Herston, Australia
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nicholas Weber
        • Contact:
        • Contact:
      • St Leonards, Australia
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chris Ward
    • New South Wales
      • Gosford NSW, New South Wales, Australia, 2250
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine Tang
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olga Motorna
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sueh-Li Lim
  • Belgium
      • Bruges, Belgium, 8000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jan Van Droogenbroeck
        • Contact:
        • Contact:
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marie-Christiane Vekemans
        • Contact:
        • Contact:
      • Ghent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas Kint
      • Hornu, Belgium, 7301
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julien Depaus
        • Contact:
        • Contact:
      • Roeselare, Belgium, 8800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rutger Callens
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mariana Bianchi Carneiro
      • Joinville, Brazil, 89201-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Pitombeira Lacerda
      • Porto Alegre, Brazil
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Capra
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jayr Schmidt Filho
        • Contact:
        • Contact:
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gracia Aparecida Martinez
      • São Paulo, Brazil, 04537-080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vania Hungria
      • São Paulo, Brazil
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abel Costa
      • Teresina, Brazil, 64049-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Lima Rocha
      • Vitória, Brazil, 29043-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Alves Aduan
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edvan de Queiroz Crusoe
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Fogliatto
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anthony Reiman
  • China
      • Beijing, China, 100191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongmei Jing
      • Chengdu, China, 610072
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • xiaobing huang
      • Chongqing, China, 400016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongbin Zhang
      • Guangzhou, China, 510060
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zhong-jun xia
        • Contact:
        • Contact:
      • Guangzhou, China, 510515
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yongqiang Wei
      • Hangzhou, China, 310003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jie Jin
      • Nanchang, China, 330000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • qingming Wang
      • Nanchang, China
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fei Li
        • Contact:
        • Contact:
      • Nanjing, China, 210008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bing Chen
      • Shanghai, China, 200032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peng Liu
      • Shanghia, China, 200080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Weijun Fu
        • Contact:
        • Contact:
      • Shenzhen, China, 518039
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xin Du
        • Contact:
        • Contact:
      • Shenzhen, China, 430022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yicheng Zhang
      • Tianjin, China, 300020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuhui Deng
      • Wenzhou, China, 325000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jiang songfu
      • Xi'an, China, 710004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wanhong Zhao
  • Czechia
      • Ostrava, Czechia, 708 52
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roman Hajek
      • Prague, Czechia, 100 34
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petr Pavlicek
  • France
      • Bobigny, France, 93009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thorsten Braun
        • Contact:
        • Contact:
      • Nantes, France, 44202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maud Voldoire
      • Villejuif, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alina Danu
  • Germany
      • Chemnitz, Germany, 9116
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mathias Haenel
      • Cologne, Germany, 50937
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Udo Holtick
      • Dresden, Germany, 01307
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thomas Illmer
        • Contact:
        • Contact:
      • Hamburg, Germany, 20246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katja Weisel
      • Hanover, Germany, 30625
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Annamaria Brioli
      • Mainz, Germany, 55131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Sebastian Michel
      • Würzburg, Germany, 97080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Martin Kortuem
        • Contact:
        • Contact:
    • Europe
      • Jena, Europe, Germany, 7747
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olaposi Yomade
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cyrus Khandanpour
  • Greece
      • Alexandroupoli, Greece, 68 100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanouil Spanoudakis
      • Athens, Greece, 106 76
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • SOSANA DELIMPASI
      • Athens, Greece, 115 28
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meletios Athanasios Dimopoulos
      • Athens, Greece
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vasiliki Pappa
      • Pátrai, Greece, 26504
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandros Spyridonidis
      • Thessaloniki, Greece, 54007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eirini Katodritou
  • India
      • Ahmedabad, India, 380009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandip Shah
      • Bangalore, India, 560054
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Santhosh Kumar Devadas
      • Hyderabad, India, 500033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • SVSS Prasad
      • Kolkata, India, 700014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tuphan Dolai
      • Kolkata, India, 700156
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeevan Kumar
      • Pune, India, 411001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sameer Melinkeri
      • Sushrut Hospital and Research, India, 400071
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Sangeeta Jiwatani
  • Ireland
      • Dublin, Ireland, D09V2N0
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Quinn
      • Galway, Ireland
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Janusz Krawczyk
      • Waterford, Ireland
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Senthil Kumar Ramesh Kumar
  • Israel
      • Beersheba, Israel, 84101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miri Zekster
      • Jerusalem, Israel, 91120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Revital Saban
      • Koranit, Israel, 2018100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Noa Lavi
        • Contact:
        • Contact:
      • Petah Tikva, Israel, 49100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • luliana Vaxman
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tamir Shragai
  • Italy
      • Ancona, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimo Offidani
      • Catania, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Di Raimondo
      • Meldola FC, Italy, 47014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Claudio Cerchione
        • Contact:
        • Contact:
      • Palermo, Italy, 90127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cirino Botta
      • Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silvia Mangiacavalli
      • Pisa, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriele Buda
      • Roma, Italy, 00161
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Teresa Petrucci
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 467-8602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinsuke Iida
      • Ehime, Japan, 790-0024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koichi Nakase
      • Ehime, Japan, 790-8524
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomoaki Fujisaki
        • Contact:
        • Contact:
      • Fukuoka, Japan, 815-8555
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazuki Tanimoto
      • Fukushima, Japan, 960-1295
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Takayuki Ikezoe
        • Contact:
        • Contact:
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hiroshi Handa
        • Contact:
        • Contact:
      • Hyōgo, Japan, 660-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mitsumasa Watanabe
      • Hyōgo, Japan, 670-8540
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yasushi Hiramatsu
        • Contact:
        • Contact:
      • Ibaraki, Japan, 300-0028
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • seiichi shimizu
      • Ishikawa, Japan, 920-8641
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Takamatsu
      • Kanagawa, Japan, 211-8510
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nobuhiro Ohno
      • Miyagi, Japan, 983-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • TORU IZUMI
      • Nara, Japan, 632-8552
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Akasaka
      • Numakunai, Japan, 028-3695
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigeki Ito
        • Contact:
        • Contact:
      • Osaka, Japan, 589-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kentaro Serizawa
      • Sapporo, Japan, 003-0006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuichi Ota
      • Suita, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michiko Ichii
        • Contact:
        • Contact:
      • Tokyo, Japan, 105-8471
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kazuhito Suzuki
        • Contact:
        • Contact:
      • Yamagata, Japan, 990-9585
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Satoshi Ito
        • Contact:
        • Contact:
    • Tokyo
      • Shibuya-Ku, Tokyo, Japan, 150-8935
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadao Ishida
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Galina Tsykunova
      • Lrenskog, Norway, 1470
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anette Loken Eilertsen
      • Oslo, Norway
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fredrik Schjesvold
  • Poland
      • Lodz, Poland, 93-513
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Pawel Robak
        • Contact:
        • Contact:
      • Lublin, Poland, 20-954
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Krzysztof Giannopoulos
        • Contact:
        • Contact:
      • Lublin, Poland
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marek Hus
      • Warsaw, Poland, 02-781
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joanna Romejko-Jarosinska
      • Wałbrzych, Poland, 58-309
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aleksandra Butrym
  • South Africa
      • Kuils River, South Africa, 7580
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Cass
      • Pretoria, South Africa, 0181
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucille Singh
  • South Korea
      • Hwasun, South Korea, 519-763
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • SUNG-HOON JUNG
        • Contact:
        • Contact:
      • Jeonju, South Korea, 561-712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • HoYoung Yhim
      • Seoul, South Korea, 03080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Youngil Koh
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Seok Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kihyun Kim
        • Contact:
        • Contact:
      • Seoul, South Korea, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • chang-ki min
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dok Hyun Yoon
        • Contact:
        • Contact:
      • Ulsan, South Korea, 44033
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jae-Cheol Jo
        • Contact:
        • Contact:
  • Spain
      • Badalona, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Abril
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mercedes Gironella Mesa
      • Gijón, Spain, 33394
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Esther Gonzalez Garcia
        • Contact:
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Joaquin Martinez
        • Contact:
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Encinas Rodriguez
        • Contact:
        • Contact:
      • Madrid, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aranzazu Alonso
      • Murcia, Spain, 30120
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • VALENTIN CABANAS
        • Contact:
        • Contact:
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • RICARDA GARCIA SANCHEZ
        • Contact:
        • Contact:
      • Salamanca, Spain
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Victoria Mateos Manteca
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrique Ocio San Miguel
      • Valladolid, Spain, 47003
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alfonso Garcia de Coca
        • Contact:
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shih-Feng Cho
      • Taichung, Taiwan, 407219
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Po-Hsien Li
      • Tainan, Taiwan, 704
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ya-Ting Hsu
      • Taipei, Taiwan, 10002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • SHANG YI Huang
      • Taoyuan District, Taiwan, 33305
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung Chang
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01330
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guldane Cengiz Seval
      • Ankara, Turkey (Türkiye), 06680
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meral Beksac
      • Sisli - Istanbul, Turkey (Türkiye), 34381
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Omur Sevindik
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • ANIL TOMBAK
        • Contact:
        • Contact:
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06170
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmet Kursad Gunes
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pinar Tarkun
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mamta Garg
        • Contact:
        • Contact:
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Horan
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karthik Ramasamy
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hannah Hunter
        • Contact:
        • Contact:
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Supratik Basu
        • Contact:
        • Contact:
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Furhan Yunus
        • Contact:
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Udit Yadav
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Afshin Gabayan
      • Pasadena, California, United States, 91105
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Amitabha Mazumder
        • Contact:
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Burke
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kimberley Doucette
        • Contact:
        • Contact:
    • Florida
      • Englewood, Florida, United States, 34223
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Blessy Jacob
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Cultrera
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isaac Levy
      • Saint Augustine, Florida, United States, 32256
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Bubis
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Vikas Gupta
        • Contact:
    • Maine
      • Portland, Maine, United States, 04074
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Rogers
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Muthalagu Ramanathan
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Pianko
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Craig Cole
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Siegel
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mateo Mejia Saldarriaga
      • Stony Brook, New York, United States, 11790
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Schuster
        • Contact:
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Raymond Thertulien
        • Contact:
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Raymond Thertulien
        • Contact:
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yvonne Efebera
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rabin Niroula
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Melear
      • Austin, Texas, United States, 78712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Matsui
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Saleha Sajid
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Renshaw
      • Tyler, Texas, United States, 75702
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Habte Yimer
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mitul Gandhi
        • Contact:
        • Contact:
    • Washington
      • Puyallup, Washington, United States, 98373
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sibel Blau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
  2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
  3. NDMM with a requirement for treatment as documented per IMWG criteria.

  4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:

    1. Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or
    2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or
    3. Serum free light-chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

  5. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:

    1. Exclusion from treatment with ASCT due to country- or site-specific age restriction.
    2. Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  7. Adequate organ system function as defined by the laboratory assessments.

  8. Male participants:

    • Contraceptive use by men 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 Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:
    • Refrain from donating fresh unwashed semen

    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
    • Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.

  9. Female participants

    • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
    • Is not a WOCBP OR
    • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
    • A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention.
    • Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology.

Exclusion Criteria:

  1. Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells >5%).
  2. Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.
  3. Signs of meningeal or central nervous system involvement with multiple myeloma.
  4. Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.
  5. 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.
  6. Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment).
  7. Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are any other malignancy that has been considered medically stable for at least 2 years, after discussion with the GSK Medical Monitor. The participant must not be receiving active therapy, other than hormonal therapy for this disease.

  8. Evidence of cardiovascular risk including any of the following:

    1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block.
    2. Recent history (within 3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty or stenting, or bypass grafting.
    3. Class III or IV heart failure as defined by the New York Heart Association functional classification system.

  9. Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:

    1. Established antiretroviral therapy for at least 4 weeks and HIV viral load <400 copies/mL within Screening Period.
    2. CD4+ T-cell (CD4+) counts ≥350 cells/μL.
    3. No history of acquired immune deficiency syndrome-defining opportunistic infections within the last 12 months.

  10. 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 intervention unless the participant can meet the following criteria:

    1. RNA test negative.
    2. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C viral load RNA test after a washout period of at least 4 weeks.
  11. Participants with hepatitis B will be excluded unless the defined criteria can be met.
  12. Current corneal epithelial disease except for mild punctate keratopathy.
  13. Intolerance or contraindications to antiviral prophylaxis.
  14. Unable to tolerate antithrombotic prophylaxis.
  15. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention.
  16. Plasmapheresis within 7 days prior to the first dose of study intervention.
  17. Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone

Belantamab mafodotin, lenalidomide, and dexamethasone will be administered.

Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Lenalidomide
Lenalidomide will be administered.
Active Comparator: Arm B: Daratumumab + Lenalidomide + Dexamethasone

Daratumumab, lenalidomide, and dexamethasone will be administered.

Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Dexamethasone
Dexamethasone will be administered.
Drug: Lenalidomide
Lenalidomide will be administered.
Drug: Daratumumab
Daratumumab will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Up to approximately 7 years
Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first.
Up to approximately 7 years
Number of Participants Achieving MRD Negative Status
Time Frame: Up to approximately 7 years
Defined as achieving MRD negativity at 10^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC.
Up to approximately 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 7 years
Up to approximately 7 years
PFS2
Time Frame: Up to approximately 7 years
Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier.
Up to approximately 7 years
Number of Participants Achieving CR or Better (CR+)
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Number of Participants Achieving Very Good Partial Response (VGPR) or Better
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Number of Participants Achieving Sustained MRD Negative Status
Time Frame: Up to approximately 7 years
Defined as achieving MRD negative status at 10^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR+ response per IMWG criteria by IRC.
Up to approximately 7 years
Duration of Response (DoR)
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Time to Second Next Line Therapy (TTST)
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Number of Participants With Ocular Findings on Ophthalmic Exam
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Maximum Post-baseline Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) Score
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Change From Baseline in EORTC QLQ-MY20
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Plasma Concentrations of Belantamab Mafodotin
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Plasma Concentrations of Cysteine Maleimidocaproyl Monomethyl Auristatin F (cys-mcMMAF)
Time Frame: Up to approximately 7 years
Up to approximately 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

April 28, 2031

Study Completion (Estimated)

April 28, 2031

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214828
  • 2024-516030-35 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Belantamab mafodotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe