Relapsed/refractory multiple myeloma
Conditions
Brief summary
Part 1 • Number of participants with dose-limiting toxicities (DLTs). • Number of participants with AEs and serious adverse events (SAEs). • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale). Part 2 • Overall Response Rate (ORR) as per IMWG by Investigator Assessment. • Number of participants with AEs and SAEs. • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale)., Part 2 • Overall Response Rate (ORR) as per IMWG by Investigator Assessment. • Number of participants with AEs and SAEs. • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale).
Detailed description
• Cumulative administered dose of belantamab mafodotin in combination with daratumumab, pomalidomide, and dexamethasone or in combination with pomalidomide and dexamethasone., • ORR as per IMWG (secondary endpoint for Part 1), • Very Good Partial Response (VGPR) or better (VGPR+) rate., • Time to Response (TTR) as per IMWG by Investigator assessment., • Duration of Response (DoR) as per IMWG by Investigator assessment., • Complete Response Rate (CRR) as per IMWG by Investigator assessment., • Minimal residual disease (MRD) negativity rate in the BM, Negative MRD is defined as the absence of tumor plasma cells in minimum 100,000 (105) BM cells. MRD will be assessed via next-generation flow (NGF) cytometry in participants with VGPR or better response., • Progression-Free Survival (PFS) as per IMWG by Investigator assessment., • Overall Survival (OS)., • Number of participants with abnormal ocular findings (on ophthalmic exam)., • Belantamab mafodotin dose holds., • Belantamab mafodotin observed plasma concentrations., • Number and proportion of participants with changes from baseline in ocular symptoms and related impacts as measured by the Vision Related Anamnestic Tool (only for Part 2).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 • Number of participants with dose-limiting toxicities (DLTs). • Number of participants with AEs and serious adverse events (SAEs). • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale). Part 2 • Overall Response Rate (ORR) as per IMWG by Investigator Assessment. • Number of participants with AEs and SAEs. • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale)., Part 2 • Overall Response Rate (ORR) as per IMWG by Investigator Assessment. • Number of participants with AEs and SAEs. • Number of participants with ocular toxicity of Grade ≥2 (per KVA scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Cumulative administered dose of belantamab mafodotin in combination with daratumumab, pomalidomide, and dexamethasone or in combination with pomalidomide and dexamethasone., • ORR as per IMWG (secondary endpoint for Part 1), • Very Good Partial Response (VGPR) or better (VGPR+) rate., • Time to Response (TTR) as per IMWG by Investigator assessment., • Duration of Response (DoR) as per IMWG by Investigator assessment., • Complete Response Rate (CRR) as per IMWG by Investigator assessment., • Minimal residual disease (MRD) negativity rate in the BM, Negative MRD is defined as the absence of tumor plasma cells in minimum 100,000 (105) BM cells. MRD will be assessed via next-generation flow (NGF) cytometry in participants with VGPR or better response., • Progression-Free Survival (PFS) as per IMWG by Investigator assessment., • Overall Survival (OS)., • Number of participants with abnormal ocular findings (on ophthalmic exam)., • Belantamab mafodotin dose holds., • Belantamab mafodotin | — |
Countries
Greece