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
GlaxoSmithKline
Summary
The study consists of three parts: * Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place. * Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of treatment Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, , including lenalidomide, a proteasome inhibitor, and an anti-CD3…
Interventions
- DrugUnconjugated belantamab antibody
Unconjugated belantamab antibody will be administered.
- DrugBelantamab mafodotin
Belantamab mafodotin will be administered.
- DrugUnconjugated belantamab antibody and belantamab mafodotin
Unconjugated belantamab antibody and belantamab mafodotin used in combination (delivered as separate drugs) will be administered.
- DrugUnconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin
Unconjugated belantamab antibody and belantamab mafodotin in combination with pomalidomide-dexamethasone and Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone will be administered.
Locations (27)
- GSK Investigational SiteGrand Rapids, Michigan
- GSK Investigational SiteChapel Hill, North Carolina
- GSK Investigational SiteChattanooga, Tennessee
- GSK Investigational SiteNashville, Tennessee
- GSK Investigational SiteCiudadela
- GSK Investigational SiteSan Juan Bautista