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The New England Journal of MedicineBelantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma

Combination Therapy for Relapsed Multiple Myeloma Shows Improved Progression-Free Survival

This phase 3 study evaluates the efficacy of a combination therapy using belantamab mafodotin, bortezomib, and dexamethasone (BVd) compared to daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma. The findings indicate that BVd therapy significantly improves progression-free survival, with important clinical implications for treatment strategies.

Study Design:

  • Participants: 494 patients with relapsed or refractory multiple myeloma after at least one line of therapy.
  • Randomization: 243 patients received BVd, and 251 received DVd.
  • Follow-up: Median of 28.2 months (range, 0.1 to 40.0).
  • Primary Endpoint: Progression-free survival.
  • Secondary Endpoints: Overall survival, response duration, and minimal residual disease (MRD)–negative status.

Key Findings:

  • Progression-Free Survival: Median of 36.6 months in the BVd group vs. 13.4 months in the DVd group (hazard ratio for disease progression or death, 0.41; P<0.001).
  • Overall Survival at 18 Months: 84% in the BVd group vs. 73% in the DVd group.
  • Response Duration: BVd group showed a significant advantage (P<0.001).
  • Complete Response or Better with MRD-Negative Status: Achieved by 25% in the BVd group vs. 10% in the DVd group.
  • Adverse Events: Grade 3 or higher adverse events occurred in 95% of the BVd group vs. 78% of the DVd group.
  • Ocular Events: More common in the BVd group (79%) compared to the DVd group (29%), managed with dose modifications.

HCN Medical Memo
For patients with relapsed or refractory multiple myeloma, the BVd regimen offers a significant improvement in progression-free survival. Clinicians should weigh the benefits against the higher incidence of adverse events, particularly ocular complications, and manage these proactively to optimize patient outcomes.

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