Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma
By T. Facon, Shaji K. Kumar, T. Plesner, R. Orlowski, P. Moreau, N. Bahlis, S. Basu, H. Nahi, C. Hulin, H. Quach and 20 more. New England Journal of Medicine, 2019
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BACKGROUND Lenalidomide plus dexamethasone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. We sought to determine whether the addition of daratumumab would significantly reduce the risk of disease progression or death in this population. METHODS We randomly assigned 737 patients with newly diagnosed multiple myeloma who were ineligible for autologous stem-cell transplantation to receive daratumumab plus lenalidomide and dexamethasone (daratumumab group) or lenalidomide and dexamethasone alone (control group). Treatment was to continue until the occurrence of disease progression or unacceptable side effects. The primary end point was progression-free survival. RESULTS At a median follow-up of 28.0 months, disease progression or death had occurred in 240 patients (97 of 368 patients [26.4%] in the daratumumab group and 143 of 369 patients [38.8%] in the control group). The estimated percentage of patients who were alive without disease progression at 30 months was 70.6% (95% confidence interval [CI], 65.0 to 75.4) in the daratumumab group and 55.6% (95% CI, 49.5 to 61.3) in the control group (hazard ratio for disease progression or death, 0.56; 95% CI, 0.43 to 0.73; P<0.001). The percentage of patients with a complete response or better was 47.6% in the daratumumab group and 24.9% in the control group (P<0.001). A total of 24.2% of the patients in the daratumumab group, as compared with 7.3% of the patients in the control group, had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells) (P<0.001). The most common adverse events of grade 3 or 4 were neutropenia (50.0% in the daratumumab group vs. 35.3% in the control group), anemia (11.8% vs. 19.7%), lymphopenia (15.1% vs. 10.7%), and pneumonia (13.7% vs. 7.9%). CONCLUSIONS Among patients with newly diagnosed multiple myeloma who were ineligible for autologous stem-cell transplantation, the risk of disease progression or death was significantly lower among those who received daratumumab plus lenalidomide and dexamethasone than among those who received lenalidomide and dexamethasone alone. A higher incidence of neutropenia and pneumonia was observed in the daratumumab group. (Funded by Janssen Research and Development; MAIA ClinicalTrials.gov number, NCT02252172.)
Subfields: Hematology, Oncology
View Paper: https://www.semanticscholar.org/paper/cedb96048dc839c0ba3f1452ee1f3dd602953202
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Citations in the corpus
- Multiple myeloma: 2022 update on diagnosis, risk stratification, and management (2022, methodology): “DRd has been recently approved for patients with newly diagnosed myeloma, based on the results of an international multicenter randomized trial.(87) PFS at 30 months was higher with DRd compared with Rd, 70.”
- Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management (2020, methodology): “Daratumumab, lenalidomide, dexamethasone (DRd) has shown significant activity in patients who are not candidates for transplantation, and is an additional alternative to VRd.(88)”