Belantamab Mafodotin | GSK2857916 | Clinical Trials

Belantamab mafodotin, previously known as GSK2857916, is an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate in Phase II clinical development for patients with relapsed/refractory multiple myeloma and other advanced hematologic malignancies expressing BCMA. The drug is currently evaluated in various clinical trials.


TrialTitleGSK ID / Study Record DetailPhase (Status)Sponsor/Collaborator
DREAMM-1Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916)117159 / NCT02064387Phase I

(Completed)

GlaxoSmithKline
DREAMM-2A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Subjects With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody205678 / NCT03525678Phase I

(Ongoing; recruitment complete)

GlaxoSmithKline
DREAMM-3A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK’916 Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma207495PlannedGlaxoSmithKline
DREAMM-4Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma205207 / NCT03848845Phase I/II

(Recruiting)

GlaxoSmithKline / Merck Sharp & Dohme Corp.
DREAMM-5A Phase I/II, Randomized, Open-label Platform Study of GSK2857916 with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma208887Phase I / II

(Planned)

GlaxoSmithKline
DREAMM-6To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)207497/ NCT03544281RecruitingGlaxoSmithKline / IQVIA
DREAMM-7Phase III study of GSK2857916, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in participants with relapsed/refractory multiple myeloma207503PlannedGlaxoSmithKline
DREAMM-8A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GSK2857916 in Combination with Pomalidomide and Low-Dose Dexamethasone (GSK2857916 + Pd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma207499PlannedGlaxoSmithKline
DREAMM-9A phase III study of GSK2857916 + Standard of Care (SOC) vs. SOC in first line transplant ineligible multiple myeloma patients209664PlannedGlaxoSmithKline
DREAMM-10GSK2857916 + novel agent vs. Standard of Care (SOC)207500PlannedGlaxoSmithKline

Last editorial Update: June 30, 2019