Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05714839 | A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments | PHASE1 | RECRUITING | 152 | — | — | Jun 14, 2023 | Dec 3, 2029 | May 22, 2026 | 30 | United States, Argentina +8 |
VGPR+ is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, complete response, stringent complete response)
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose escalation and expansion of the unconjugated belantamab antibody monotherapy | EXPERIMENTAL | Unconjugated belantamab antibody will be administered in participants with RRMM until progressive disease (PD) |
| Part 2:Unconjugated belantamab antibody and belantamab mafodotin-given separately dose range finding | EXPERIMENTAL | Participants with RRMM will receive unconjugated belantamab antibody and belantamab mafodotin |
| Part 3: Unconjugated belantamab +/- belantamab mafodotin +pomalidomide/dexamethasone in 2L+ RRMM | EXPERIMENTAL | Participants with second line (2L+) RRMM will receive Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin. |
| Part 1b:Optional belantamab mafodotin | EXPERIMENTAL | Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin. |
| Name | Type | Description |
|---|---|---|
| Unconjugated belantamab antibody | DRUG | Unconjugated belantamab antibody will be administered. |
| Belantamab mafodotin | DRUG | Belantamab mafodotin will be administered. |
| Unconjugated belantamab antibody and belantamab mafodotin | DRUG | Unconjugated belantamab antibody and belantamab mafodotin used in combination (delivered as separate drugs) will be administered. |
| Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin | DRUG | Unconjugated belantamab antibody and belantamab mafodotin in combination with pomalidomide-dexamethasone and Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone will be administered. |
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 Myel...