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A PHASE 1/2, DOSE AND SCHEDULE EVALUATION STUDY TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN ADMINISTERED IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE WITH OR WITHOUT DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA PREVIOUSLY TREATED WITH ONE TO THREE LINES OF THERAPY WHO ARE LENALIDOMIDE REFRACTORY

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516147-32-00
Acronym
EAE127
Enrollment
60
Registered
2024-11-27
Start date
2022-12-06
Completion date
Unknown
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory multiple myeloma

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

DRUGPOMALIDOMIDE
DRUGDEXAMETHASONE
DRUGDARZALEX 1800 mg solution for injection

Sponsors

Hellenic Society Of Hematology
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026