Spots Global Cancer Trial Database for A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
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Trial Identification
Brief Title: A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Official Title: A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma
Study ID: NCT05714839
Conditions
Study Description
Brief Summary: The study consists of three parts * Part 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM). * Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments. * Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Ciudadela, Buenos Aires, Argentina
GSK Investigational Site, Fitzroy, Victoria, Australia
GSK Investigational Site, Nedlands, Western Australia, Australia
GSK Investigational Site, Salvador, Bahía, Brazil
GSK Investigational Site, São Paulo, , Brazil
GSK Investigational Site, Aomori, , Japan
GSK Investigational Site, Osaka, , Japan
GSK Investigational Site, Seoul, Korea, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Mexico City, , Mexico
GSK Investigational Site, Gdansk, , Poland
GSK Investigational Site, Lublin, , Poland
GSK Investigational Site, Changhua, , Taiwan
GSK Investigational Site, Taipei, , Taiwan
GSK Investigational Site, Kayseri, , Turkey
GSK Investigational Site, Leicester, , United Kingdom
GSK Investigational Site, Oxford., , United Kingdom
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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