Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma (DREAMM 8)

October 31, 2023 updated by: GlaxoSmithKline

A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

357

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

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

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Edwin Lee
        • Contact:
        • Contact:
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Completed
        • GSK Investigational Site
      • Gosford, New South Wales, Australia, 2250
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cecily Forsyth
        • Contact:
        • Contact:
      • Port Macquarie, New South Wales, Australia, 2444
        • Completed
        • GSK Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mark Hertzberg
        • Contact:
        • Contact:
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Presgrave
        • Contact:
        • Contact:
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hanlon Sia
        • Contact:
        • Contact:
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ian Irving
        • Contact:
        • Contact:
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huey-Shin Cindy Lee
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hang Quach
        • Contact:
        • Contact:
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Philip Campbell
        • Contact:
        • Contact:
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrew Lim
        • Contact:
        • Contact:
      • Malvern, Victoria, Australia, 3144
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Melita Kenealy
        • Contact:
        • Contact:
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Bradley Augustson
        • Contact:
        • Contact:
  • Brazil
      • Curitiba, Brazil, 80530-010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francisco Cordeiro
        • Contact:
        • Contact:
      • Rio de Janeiro, Brazil, 22793-080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Angelo Maiolino
        • Contact:
        • Contact:
      • São Paulo, Brazil, 04537-080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vania Hungria
      • São Paulo, Brazil, 01509-900
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jayr Schmidt Filho
        • Contact:
        • Contact:
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Laura Maria Fogliatto
        • Contact:
        • Contact:
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Capra
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89201-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Pitombeira de Lacerda
  • Canada
      • Montreal, Canada, H2X 0A9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilie Lemieux-Blanchard
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arleigh McCurdy
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suzanne Trudel
  • China
      • Beijing, China, 100191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongmei Jing
      • Beijing, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhongxia Huang
      • Tianjin, China, 300020
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Weiwei Sui
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhongjun Xia
      • Shenzhen, Guangdong, China, 518029
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xin Du
        • Contact:
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chunyan Sun
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xin Li
        • Contact:
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zhiling Yan
        • Contact:
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fei Li
        • Contact:
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sujun Gao
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Wei Yang
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhen Cai
  • Czechia
      • Brno, Czechia, 625 00
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ludek Pour
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vladimir Maisnar
      • Praha 2, Czechia, 128 08
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ivan Spicka
  • France
      • Dijon cedex, France, 21079
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Denis Caillot
        • Contact:
        • Contact:
      • Marseille Cedex 9, France, 13273
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anne-Marie Stoppa
        • Contact:
        • Contact:
      • Périgueux cedex, France, 24019
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe Rodon
      • Toulouse cedex 9, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aurore Perrot
      • Vandeouvre-les-Nancy, France, 54500
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre Feugier
  • Germany
      • Berlin, Germany, 12351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maike de Wit
      • Hamburg, Germany, 20246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katja Weisel
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Raab
        • Contact:
        • Contact:
      • Tuebingen, Baden-Wuerttemberg, Germany, 72076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Britta Besemer
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Martin Kortuem
        • Contact:
        • Contact:
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55101
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Markus Munder
        • Contact:
        • Contact:
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wolfram Poenisch
    • Thueringen
      • Jena, Thueringen, Germany, 07747
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marie von Lilienfeld-Toal
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 10676
        • 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, 11525
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Konstantinos Anargyrou
        • Contact:
        • Contact:
      • Athens, Greece, 11527
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Athanasios Galanopoulos
        • Contact:
        • Contact:
      • Ioannina, Greece, 45 500
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eleftheria Hatzimichael
        • Contact:
        • Contact:
      • Larisa, Greece, 41110
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • George Vassilopoulos
        • Contact:
        • Contact:
      • Rio/Patras, Greece, 26504
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Argiris S. Symeonidis
      • Thessaloniki, Greece, 57010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michail Iskas
        • Contact:
        • Contact:
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Evdoxia Hatjiharissi
        • Contact:
        • Contact:
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Merav Leiba
        • Contact:
        • Contact:
      • Beer-Sheva, Israel, 84101
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ory Rouvio
        • Contact:
        • Contact:
      • Haifa, Israel, 31096
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Inna Tsoran-Rosenthal
        • Contact:
        • Contact:
      • Jerusalem, Israel, 91120
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Moshe Etzion Gatt
        • Contact:
        • Contact:
      • Jerusalem, Israel, 91031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosa Ruchlemer
      • Kfar Saba, Israel, 44281
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Osnat Jarchowsky Dolberg
        • Contact:
        • Contact:
      • Nahariya, Israel, 22100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Celia Suriu
        • Contact:
        • Contact:
      • Petach Tikva, Israel, 49100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Amos M Cohen
        • Contact:
        • Contact:
      • Ramat Gan, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hila Magen
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Irit Avivi
        • Contact:
        • Contact:
  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luca Baldini
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michele CAVO
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maurizio Martelli
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Silvia Mangiacavalli
    • Puglia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicola Cascavilla
  • Japan
      • Aichi, Japan, 467-8602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shinsuke Iida
      • Chiba, Japan, 296-8602
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kosei Matsue
        • Contact:
        • Contact:
      • Ehime, Japan, 790-8524
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomoaki Fujisaki
        • Contact:
        • Contact:
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hiromi Iwasaki
        • Contact:
        • Contact:
      • 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:
      • Gunma, Japan, 377-0280
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Morio Matsumoto
        • Contact:
        • Contact:
      • Hiroshima, Japan, 720-0001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Taiga Kuroi
        • Contact:
        • Contact:
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hideki Goto
        • Contact:
        • Contact:
      • Iwate, Japan, 028-3695
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shigeki Ito
        • Contact:
        • Contact:
      • Kumamoto, Japan, 860-0008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Toshiro Kawakita
        • Contact:
        • Contact:
      • Kyoto, Japan, 602-8566
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Junya Kuroda
      • Okayama, Japan, 701-1192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazutaka Sunami
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michiko Ichii
        • Contact:
        • Contact:
      • Saitama, Japan, 350-0495
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yasuhito Terui
        • Contact:
        • Contact:
      • Tokushima, Japan, 770-8539
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shuji Ozaki
        • Contact:
        • Contact:
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kazuhito Suzuki
        • Contact:
        • Contact:
      • Tokyo, Japan, 108-8639
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yoichi Imai
        • Contact:
        • Contact:
      • Tottori, Japan, 683-8504
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tetsuya Fukuda
        • Contact:
        • Contact:
      • Yamagata, Japan, 990-9585
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Satoshi Ito
        • Contact:
        • Contact:
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ho-Jin Shin
      • Gyeonggi-do, Korea, Republic of, 10408
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • HyeonSeok Eom
        • Contact:
        • Contact:
      • Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Je-Jung Lee
      • Incheon, Korea, Republic of, 405-760
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jae Hoon Lee
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin Seok Kim
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chang Ki Min
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kihyun Kim
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Youngil Koh
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jae-Cheol Jo
        • Contact:
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 2025
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sharon Jackson
        • Contact:
        • Contact:
      • Auckland, New Zealand, 622
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Merit Hanna
        • Contact:
        • Contact:
      • Christchurch, New Zealand, 8011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Ganly
        • Contact:
        • Contact:
      • Dunedin, New Zealand, 9001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kathryn Forwood
        • Contact:
        • Contact:
      • Grafton, Auckland, New Zealand, 1023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Browett
      • Hamilton, New Zealand, 2001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hugh Goodman
        • Contact:
        • Contact:
      • Tauranga, New Zealand, 3143
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marie Hughes
        • Contact:
        • Contact:
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaroslaw Czyz
      • Gdansk, Poland, 80-214
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Magdalena Dutka
        • Contact:
        • Contact:
      • Krakow, Poland, 31-501
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Artur Jurczyszyn
        • Contact:
        • Contact:
      • Lodz, Poland, 93-513
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tadeusz Robak
        • Contact:
        • Contact:
      • Lublin, Poland, 20-090
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Krzysztof Giannopoulos
        • Contact:
        • Contact:
      • Wroclaw, Poland, 50-367
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomasz Wrobel
  • Russian Federation
      • Kaluga, Russian Federation, 248007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elena Borisenkova
        • Contact:
        • Contact:
      • Moscow, Russian Federation, 125284
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sergey Semochkin
        • Contact:
        • Contact:
      • Nizhniy Novgorod, Russian Federation, 603126
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Olga Samoilova
        • Contact:
        • Contact:
      • Novosibirsk, Russian Federation, 630087
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yulia Dyachkova
        • Contact:
        • Contact:
      • Omsk, Russian Federation, 644013
        • Withdrawn
        • GSK Investigational Site
      • Saint Petersburg, Russian Federation, 197341
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yuriy Osipov
        • Contact:
        • Contact:
      • Samara, Russian Federation, 443099
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Igor Davydkin
        • Contact:
        • Contact:
      • Sochi, Russian Federation, 354057
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dmitriy Kirtbaya
        • Contact:
        • Contact:
      • St'Petersburg, Russian Federation, 191024
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sergey Voloshin
        • Contact:
        • Contact:
      • St. Petersburg, Russian Federation, 197 089
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Olga S. Uspenskaya
        • Contact:
        • Contact:
      • Tula, Russian Federation, 300053
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elena Volodicheva
        • Contact:
        • Contact:
  • Spain
      • Badalona, Spain, ?08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Rosinol Dachs
      • Barcelona, Spain, 8035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mercedes Gironella Mesa
      • Barcelona, Spain, 08908
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ana Maria Sureda Balarí
        • Contact:
        • Contact:
      • Gijon, Spain, 33204
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Esther González García
        • Contact:
        • Contact:
      • Madrid, Spain, 28006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Adrián Alegre Amor
        • Contact:
        • Contact:
      • Murcia, Spain, 30008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Felipe De Arriba de la Fuente
        • Contact:
        • Contact:
      • Palma de Mallorca, Spain, 07010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Antonia Sampol Mayol
        • Contact:
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Rodriguez Otero
        • Contact:
        • Contact:
      • Pozuelo De Alarcón/Madrid, Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carmen Martinez Chamorro
        • Contact:
        • Contact:
      • Salamanca, Spain, 37007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Victoria Mateos Manteca
      • Sevilla, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesús Martín Sánchez
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Javier de la Rubia Comos
        • Contact:
        • Contact:
    • Madrid
      • Móstoles, Madrid, Spain, 28933
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alberto Velasco Valdazo
        • Contact:
        • Contact:
    • Navarra
      • Madrid, Navarra, Spain, 28027
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Rodriguez Otero
        • Contact:
        • Contact:
  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mehmet Sinan Dal
        • Contact:
        • Contact:
      • Ankara, Turkey, 06560
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zubeyde Ozkurt
        • Contact:
        • Contact:
      • Ankara, Turkey, 6110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meral Beksac
      • Istanbul, Turkey, 34214
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Omur G Sevindik
        • Contact:
        • Contact:
      • Izmir, Turkey, 35100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Guray Saydam
        • Contact:
        • Contact:
      • Izmir, Turkey, 35340
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guner Hayri Ozsan
      • Kocaeli, Turkey, 41400
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Zafer Gulbas
        • Contact:
        • Contact:
      • Mersin, Turkey, 33343
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anil Tombak
        • Contact:
        • Contact:
      • Samsun, Turkey, 55139
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mehmet Turgut
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rachel Hall
        • Contact:
        • Contact:
      • London, United Kingdom, W12 0HS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aristeidis Chaidos
      • Plymouth, United Kingdom, PL6 8D8
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hannah Mary Hunter
        • Contact:
        • Contact:
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Matthew Jenner
        • Contact:
        • Contact:
    • Lanarkshire
      • Airdrie, Lanarkshire, United Kingdom, ML6 0JS
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Iain Singer
        • Contact:
        • Contact:
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kamaraj Karunanithi
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kevin Boyd
        • Contact:
        • Contact:
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Manuel R Modiano
        • Contact:
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Henning Schade
        • Contact:
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Syed Farhan Zafar
        • Contact:
        • Contact:
      • New Port Richey, Florida, United States, 34655
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustaro A Fonseca
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isaac Levy
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Danko Martincic
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Richardson
        • Contact:
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Suman Kambhampati
        • Contact:
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Santhosh Sadashiv
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jesus G Berdeja
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Edward Libby
        • Contact:
        • Contact:
      • Spokane, Washington, United States, 99202
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Brett Gourley
        • Contact:
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Binod Dhakal
        • Contact:
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Capable of giving signed informed consent.
  • Male or female, 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible).

  • Must have at least 1 aspect of measurable disease defined as one of the following;

    1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or
    2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter [L]), or
    3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than [<]0.26 or greater than [>]1.65) only if participant has no measurable urine or serum M spike.
  • Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was >100 days prior to the first dose of study medication. b. No active bacterial, viral, or fungal infection(s) present
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia.
  • Adequate organ system functions as mentioned in the protocol.
  • Male and female participants agree to abide by protocol-defined contraceptive requirements.

Exclusion Criteria:

  • Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
  • Prior allogeneic SCT.
  • Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
  • Plasmapheresis within 7 days prior to the first dose of study drug.
  • Received prior treatment with or intolerant to pomalidomide.
  • Received prior Beta cell maturation antigen (BCMA) targeted therapy.
  • Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square [m^2] twice weekly).

  • 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 (AV) 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 (NYHA) functional classification system
    4. Uncontrolled hypertension.
  • Any major surgery within the last 4 weeks.

  • Previous or concurrent invasive malignancy other than multiple myeloma, except:

    1. The disease must be considered medically stable for at least 2 years; or
    2. The participant must not be receiving active therapy, other than hormonal therapy for this disease.
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Evidence of active mucosal or internal bleeding.
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
  • Active infection requiring treatment.
  • Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met.
  • Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety).
  • Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy.
  • Active or history of venous and arterial thromboembolism within the past 3 months.
  • Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis.
  • Current corneal disease except for mild punctate keratopathy.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Pregnant or lactating female.

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 plus Pomalidomide and Dexamethasone
Drug: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity will be administered.
Drug: Pomalidomide
Immunomodulatory drug (IMiD) will be administered.
Active Comparator: Arm B: Bortezomib plus Pomalidomide and Dexamethasone
Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity will be administered.
Drug: Bortezomib
Proteasome Inhibitor will be administered.
Drug: Pomalidomide
Immunomodulatory drug (IMiD) will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 84 months
PFS will be defined as the time from the randomization until the earliest date of progressive disease (PD) based on Independent Review Committee (IRC) assessment per International Myeloma Working Group (IMWG) criteria, or death due to any cause
Up to 84 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to 84 months
Up to 84 months
Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters
Time Frame: Up to 84 months
Up to 84 months
Number of participants with abnormal ocular findings on ophthalmic examination
Time Frame: Up to 84 months
Up to 84 months
Plasma concentrations of belantamab mafodotin at indicated time points
Time Frame: Up to 84 months
Up to 84 months
Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points
Time Frame: Up to 84 months
Up to 84 months
Maximum observed concentration (Cmax) for pomalidomide
Time Frame: Up to 24 hours
Up to 24 hours
Time of Cmax (Tmax) for pomalidomide
Time Frame: Up to 24 hours
Up to 24 hours
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for pomalidomide
Time Frame: Up to 24 hours
Up to 24 hours
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Time Frame: Up to 84 months
Up to 84 months
Titers of ADAs against belantamab mafodotin
Time Frame: Up to 84 months
Up to 84 months
Change from Baseline in health related quality of life (HRQoL) as measured by European Organization for Research and Treatment of Cancer Quality of life Questionnaire 30-item core module (EORTC QLQ-C30)
Time Frame: Baseline and up to 84 months
EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.
Baseline and up to 84 months
Change from Baseline in HRQoL as measured by EORTC item library 52 (IL52)
Time Frame: Baseline and up to 84 months
EORTC QLQ- 20-item Multiple Myeloma Module (MY20) questionnaire will be referred to as the EORTC IL52. Only disease symptoms domain will be assessed. A high score represents a high level of symptoms or problems.
Baseline and up to 84 months
Change from Baseline in HRQoL as measured by EORTC QLQ-20-item Multiple Myeloma Module (MY20)
Time Frame: Baseline and up to 84 months
EORTC QLQ-MY20 is a questionnaire which will evaluate disease symptoms. In EORTC QLQ-MY20, domain scores will be averaged and will be transformed linearly to a score ranging from 0 to 100. Higher score represents high level of symptomatology or problems.
Baseline and up to 84 months
Number of participants with maximum post-baseline changes in patient-reported outcome version of the common terminology criteria for adverse events (PRO-CTCAE) scores for each item attribute
Time Frame: Baseline and up to 84 months
PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.
Baseline and up to 84 months
Duration of response (DoR)
Time Frame: Up to 84 months
DoR will be defined as the time from first documented evidence of partial response or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria.
Up to 84 months
Minimal residual disease (MRD) negativity rate
Time Frame: Up to 84 months
MRD negativity rate will be defined as the percentage of participants who achieve MRD negative status (as assessed by next-generation sequencing (NGS) at 10^5 threshold) at least once during the time of confirmed CR or better response, based on IRC assessment per IMWG.
Up to 84 months
Overall survival (OS)
Time Frame: Up to 84 months
OS will be defined as the interval of time from randomization to the date of death due to any cause.
Up to 84 months
Overall response rate (ORR)
Time Frame: Up to 84 months
ORR will be defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Up to 84 months
Complete response rate (CRR)
Time Frame: Up to 84 months
CRR will be defined as the percentage of participants with a confirmed complete response or better (i.e., CR and stringent complete respone (sCR) based on IRC-assessment per IMWG criteria.
Up to 84 months
Very good partial response (VGPR) or better rate
Time Frame: Up to 84 months
VGPR will be the defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria.
Up to 84 months
Time to best response (TTBR)
Time Frame: Up to 84 months
TTBR will be defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG.
Up to 84 months
Time to response (TTR)
Time Frame: Up to 84 months
TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG.
Up to 84 months
Time to progression (TTP)
Time Frame: Up to 84 months
TTP defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD.
Up to 84 months
Progression-free survival on subsequent line of therapy (PFS2)
Time Frame: Up to 84 months
PFS2 defined as time from randomization to disease progression (investigator-assessed response) after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new anti-myeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier.
Up to 84 months

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, 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)

October 1, 2020

Primary Completion (Estimated)

September 16, 2024

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207499
  • 2018-004354-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

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