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The New England Journal of MedicineDaratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

Daratumumab Enhances Efficacy of Standard Myeloma Regimen in Transplantation-Eligible Patients


A recent phase 3 clinical trial has shed light on the potential benefits of adding subcutaneous daratumumab, a monoclonal antibody targeting CD38, to a standard myeloma regimen (VRd: bortezomib, lenalidomide, and dexamethasone) in transplantation-eligible patients with newly diagnosed multiple myeloma. The study provides valuable insights into the efficacy and safety of this approach.

Study Design:

  • The trial involved 709 transplantation-eligible patients with newly diagnosed multiple myeloma.
  • Patients were randomly assigned to two groups: one received daratumumab combined with VRd (D-VRd group), and the other received VRd alone.
  • The primary endpoint was progression-free survival, with secondary endpoints being a complete response or better and minimal residual disease (MRD)–negative status.
  • The median follow-up period was 47.5 months.

Key Findings:

  • The D-VRd group showed a lower risk of disease progression or death, with 84.3% of patients having progression-free survival at 48 months, compared to 67.7% in the VRd group.
  • The D-VRd group also had a higher percentage of patients with a complete response or better (87.9% vs. 70.1%) and MRD-negative status (75.2% vs. 47.5%).
  • Most patients in both groups experienced grade 3 or 4 adverse events, with neutropenia and thrombocytopenia being the most common.
  • Serious adverse events occurred in 57.0% of the patients in the D-VRd group and 49.3% of those in the VRd group.

HCN Medical Memo
According to the American Cancer Society, about 35,730 new cases of multiple myeloma will be diagnosed in 2023, with estimated deaths numbering just under 12,600.


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