Clinical Scorecard: Findings from Arm A of the Phase 1/2 DREAMM-6 Study: Belantamab Mafodotin Combined with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

At a Glance

Key Highlights

• Overall response rate (ORR) was 67% with a complete response rate (CRR) of 29% in the all-treated population.
• Common Grade 3/4 adverse events included keratopathy (53%), decreased neutrophil count (22%), decreased platelet count (22%), and reduced visual acuity (22%).
• Median progression-free survival (PFS) was 18.4 months, with some cohorts not reaching median PFS at data cutoff.

Guideline-Based Recommendations

Diagnosis

• Assess response using International Myeloma Working Group (IMWG) criteria every 4 weeks.
• Monitor ocular events with slit lamp examination and best corrected visual acuity (BCVA) scoring.

Management

• Administer belantamab mafodotin at doses of 1.9 mg/kg or 2.5 mg/kg combined with standard lenalidomide and dexamethasone regimens.
• Manage ocular adverse events proactively with dose modifications and ophthalmic monitoring.
• Monitor and manage thrombocytopenia; dose modifications may not be required in all cases.

Monitoring & Follow-up

• Regular ophthalmic exams to detect keratopathy and visual acuity changes.
• Monitor blood counts for neutropenia and thrombocytopenia.
• Surveillance for infections, especially pneumonia.

Risks

• High incidence of ocular adverse events including keratopathy and reduced visual acuity.
• Risk of serious infections including pneumonia; some fatal serious adverse events reported.
• Potential for thrombocytopenia and neutropenia requiring monitoring.

Patient & Prescribing Data

Patients with RRMM, median age 68 years, majority male, with prior exposure to lenalidomide and daratumumab.

Belantamab mafodotin combined with lenalidomide and dexamethasone shows promising efficacy with manageable safety profile; ocular toxicity is common but often resolves.

Clinical Best Practices

• Use protocol-defined ocular grading scales alongside NCI-CTCAE for comprehensive ocular toxicity assessment.
• Schedule frequent ophthalmic evaluations to detect and manage ocular adverse events early.
• Consider dose splitting or extended dosing intervals to potentially reduce ocular toxicity.
• Educate patients on signs of ocular toxicity and infection for prompt reporting.
• Monitor hematologic parameters closely and adjust treatment as needed to manage cytopenias.

References

• DREAMM-6 Clinical Trial NCT03544281
• International Myeloma Working Group Response Criteria
• DREAMM-7 Phase 3 Trial NCT04246047
• DREAMM-8 Phase 3 Trial NCT04484623