Phase 2
Completed N=177
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT05064358 ↗Enrolled (actual)
177
Serious AEs
42.9%
Results posted
Oct 2025
Primary outcomePrimary: Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale — 64; 40; 44; 38 Percentage of participants
Summary
This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale |
64; 40; 44; 38 | — |
| SECONDARY Number of Participants With Corneal Events up to Week 16 |
26; 25; 23; 24; 12 | — |
| SECONDARY Incidence Rate of Corneal Events by Grade (KVA Scale) |
3; 10; 7; 10; 2; 10 | — |
| SECONDARY Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade |
4; 2; 4; 0; 3; 0 | — |
| SECONDARY Median Duration of All the Dose Delays |
39.0; 18.0; 51.0; 60.0; 59.0 | — |
| SECONDARY Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events |
31; 28; 26; 23; 35; 59 | — |
| SECONDARY Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale) |
59; 32; 36; 33; 53; 64 | — |
| SECONDARY Toxicity Index (TI) |
3.68; 3.83; 3.87; 3.43; 3.64 | — |
| SECONDARY Duration of Corneal Events of Grade 2 or Above |
63.0; 67.5; 46.5; 53.5; 44.0 | — |
| SECONDARY Percentage of Time on Study With Grade 2 or Above Corneal Events |
23.27; 24.86; 18.99; 23.67; 35.63 | — |
| SECONDARY Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores |
16; 20; 19; 27; 8; 2 | — |
| SECONDARY Objective Response Rate (ORR) |
33; 25; 28; 25; 18 | — |
| SECONDARY Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR) |
25; 18; 8; 15; 18 | — |
| SECONDARY Time to Response (TTR) |
0.8; 1.1; 0.7; 0.8; 1.5 | — |
| SECONDARY Duration of Response (DoR) |
15.9; 22.1; 6.2; 7.8; 15.9 | — |
| SECONDARY Time to Progression (TTP) |
6.0; 2.1; 2.8; 2.7; 2.9 | — |
| SECONDARY Progression Free Survival (PFS) |
5.7; 2.1; 2.8; 2.7; 2.8 | — |
| SECONDARY Overall Survival (OS) |
20.9; 15.0; 13.5; 14.5; NA | — |
| SECONDARY Percentage of Participants With AEs |
100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs |
8; 13; 5; 5; 18; 31 | — |
| SECONDARY Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline |
3; 1; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline |
9; 14; 12; 9; 2; 2 | — |
| SECONDARY Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin |
0; 0; 0; 0; 0 | — |
| SECONDARY Titers of ADAs Against Belantamab Mafodotin |
— | — |
| SECONDARY Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC) |
44.8; 33.1; 42.1; 33.1; 34.1 | — |
| SECONDARY Concentration at 21 Days for Belantamab Mafodotin ADC |
2.28; 1.5; 1.94; 1.69; 1.53 | — |
| SECONDARY Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC |
8.4; 5.98; 7.71; 6.3; 6.11 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC |
4233; 3013; 3886; 3173; 3079 | — |
| SECONDARY Half-life (t1/2) of Belantamab Mafodotin ADC |
13; 12; 12; 12; 13 | — |
| SECONDARY Clearance (CL) for Belantamab Mafodotin ADC |
0.8; 0.83; 0.84; 0.74; 0.86 | — |
| SECONDARY Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC |
10.0; 9.3; 9.4; 8.9; 10.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
- France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
- Participant has measurable disease per modified IMWG criteria.
- Life expectancy of at least 6 months, in the opinion of the investigator.
- Male and female participants agree to abide by protocol-defined contraceptive requirements.
- Participant is capable of giving signed informed consent.
- Participant meets country-specific inclusion criteria described in the protocol.
Exclusion Criteria
- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
- Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
- Evidence of active mucosal or internal bleeding.
- Presence of an active renal condition.
- Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
- Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- Evidence of cardiovascular risk as per the protocol criteria.
- Pregnant or lactating female.
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
- Hepatitis B and C will be excluded unless the criteria in protocol can be met.
- Cirrhosis or current unstable liver or biliary disease.
- Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
- Total Bilirubin >1.5×ULN.
- Systemic anti-MM therapy within 500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
- UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L
Data sourced from ClinicalTrials.gov (NCT05064358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.