Belantamab mafodotin vs HRC0202

NCT03525678 · Phase 2 · completed

This was a randomized but open-label phase 2 study in which all participants received belantamab mafodotin at one of two doses or formulations; there was no placebo or active comparator arm and no blinding. The primary endpoint was overall response rate by independent review, a clinical response measure, but the results are reported as per-arm rates with confidence intervals and no formal statistical comparison against a control, so the study cannot distinguish drug effect from natural history or placebo effect. The evidence is therefore descriptive phase 2 evidence of activity, not strong comparative evidence.

NCT04003168 · Phase 1 · status unknown

This is a small, single-arm, open-label safety study with no control group, so it cannot show whether the therapy works better than an alternative. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

The published report covers seven treated patients, fewer than the study's listed enrollment.