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.
| Trial | Title | GSK ID / Study Record Detail | Phase (Status) | Sponsor/Collaborator |
|---|---|---|---|---|
| DREAMM-1 | Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) | 117159 / NCT02064387 | Phase I (Completed) | GlaxoSmithKline |
| DREAMM-2 | A 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 Antibody | 205678 / NCT03525678 | Phase I (Ongoing; recruitment complete) | GlaxoSmithKline |
| DREAMM-3 | A 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 Myeloma | 207495 | Planned | GlaxoSmithKline |
| DREAMM-4 | Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma | 205207 / NCT03848845 | Phase I/II (Recruiting) | GlaxoSmithKline / Merck Sharp & Dohme Corp. |
| DREAMM-5 | A Phase I/II, Randomized, Open-label Platform Study of GSK2857916 with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma | 208887 | Phase I / II (Planned) | GlaxoSmithKline |
| DREAMM-6 | To 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/ NCT03544281 | Recruiting | GlaxoSmithKline / IQVIA |
| DREAMM-7 | Phase III study of GSK2857916, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in participants with relapsed/refractory multiple myeloma | 207503 | Planned | GlaxoSmithKline |
| DREAMM-8 | A 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 Myeloma | 207499 | Planned | GlaxoSmithKline |
| DREAMM-9 | A phase III study of GSK2857916 + Standard of Care (SOC) vs. SOC in first line transplant ineligible multiple myeloma patients | 209664 | Planned | GlaxoSmithKline |
| DREAMM-10 | GSK2857916 + novel agent vs. Standard of Care (SOC) | 207500 | Planned | GlaxoSmithKline |
Last editorial Update: June 30, 2019
