Table 4.
Selected Trials of Belantamab Mafodotin in Multiple Myeloma (MM)
| Trial ID (References) | Treatment | Phase | Enrollment (N) | Trial Title |
|---|---|---|---|---|
| NCT02064387128 | BelMaf | I | 79 | A phase I open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of the antibody drug conjugate GSK2857916 in subjects with RRMM and other advanced hematologic malignancies expressing BCMA (DREAMM-1) |
| NCT03525678129,130 | BelMaf | II | 221 | A phase II, open label, randomized, two-arm study to investigate the efficacy and safety of two doses of the antibody drug conjugate GSK2857916 in participants with MM who had 3 or more prior lines of treatment, are refractory to a proteasome inhibitor and an immunomodulatory agent and have failed an anti-CD38 antibody (DREAMM 2) |
| NCT04162210131 | BelMaf vs (Pom + Dex) | III | 380 | A phase III, open-label, randomized study to evaluate the efficacy and safety of single agent belantamab mafodotin compared to pomalidomide plus low dose dexamethasone in participants with RRMM (DREAMM 3) |
| NCT03848845132 | BelMaf + Pembro | I/II | 41 | A phase I/II single arm open-label study to explore safety and clinical activity of GSK2857916 administered in combination with pembrolizumab in subjects with RRMM (DREAMM 4) |
| NCT03544281133,134 | BelMaf + Dex + (Len or Bort) | I/II | 152 | A phase I/II, open-label, dose escalation and expansion study to evaluate safety, tolerability, and clinical activity of GSK2857916 administered in combination with lenalidomide plus dexamethasone, or bortezomib plus dexamethasone in participants with RRMM (DREAMM-6) |
| NCT04246047135 | Bort + Dex + (BelMaf or Dara) | III | 478 | DREAMM 7: a multicenter, open-label, randomized phase III study to evaluate the efficacy and safety of the combination of belantamab mafodotin, bortezomib, and dexamethasone compared with the combination of daratumumab, bortezomib, and dexamethasone in participants with RRMM |
| NCT04484623136 | Pom + Dex + (BelMaf or Bort) | III | 450 | A phase III, multicenter, open-label, randomized study to evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone versus pomalidomide plus bortezomib and dexamethasone in participants with RRMM (DREAMM 8) |
| NCT04091126137 | Bort + Len + Dex (± BelMaf) | I | 144 | A Phase I, randomized, dose and schedule evaluation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin administered in combination with standard of care in participants with newly diagnosed MM (DREAMM 9) |
| NCT04398745 | BelMaf | I | 36 | A phase I study to evaluate the pharmacokinetics and safety of belantamab mafodotin monotherapy in participants with RRMM who have normal and varying degrees of impaired renal function (DREAMM 12) |
| NCT04398680 | BelMaf | I | 28 | A phase I study to evaluate the pharmacokinetics and safety of belantamab mafodotin monotherapy in participants with RRMM who have normal and varying degrees of impaired hepatic function (DREAMM 13) |
Abbreviations: BelMaf, belantamab mafodotin; Bort, bortezomib; Dara, daratumumab; Dex, dexamethasone; Len, lenalidomide; Pembro, pembrolizumab; Pom, pomalidomide.