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Phase II clinical trial of personalized VCD-VTD sequential therapy using the Vulnerable Elders Survey-13 (VES-13) for transplant-ineligible patients with newly diagnosed multiple myeloma


The Vulnerable Elders Survey-13 (VES-13) is a well-studied simplified frailty screening tool for elderly patients in the oncology setting. We conducted a prospective clinical trial to evaluate the efficacy and safety of dose-adjusted treatment based on the VES-13 in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). In the Fit group (VES-13 <3), patients were treated with 4 cycles of standard-dose VCD (bortezomib, cyclophosphamide, and dexamethasone) followed by 4 cycles of standard-dose VTD (bortezomib, thalidomide, and dexamethasone). In the Frail group (VES-13 ≥3), patients were treated with 4 cycles of reduced-dose VCD followed by 4 cycles of reduced-dose VTD. The median age was 75 years (66–86 years), and 34% of the cases were classified as PS 3. Among the Fit group (n=16), the overall response rate (ORR) was 87.5%. Among the Frail group (n=31), the ORR was 87.1%. There were no significant differences in progression-free survival (PFS) and overall survival (OS) between the Fit and Frail groups (3-year PFS: 68.8% vs 53.3%, P = 0.658; 3-year OS: 70.0% vs 77.6%, P = 0.919). Personalized VCD-VTD sequential therapy based on the VES-13 was associated with high response rates and showed acceptable safety in elderly frail patients with MM. The study is registered as UMIN000011235.

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We gratefully acknowledge all the patients and families who participated in the study. We would also like to thank Takayuki Abe for the data analysis and Keiko Fukushima for the data management.

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Authors and Affiliations



T.N. wrote the manuscript, analyzed data, and performed the research. M.H., N.S., Y.T., R.I., S.T., A.W., K.T., R.S., T.K., J.H., M.I., and Y.A. recruited patients in the study and performed the research. S.F., K.M., S.I., E.T., and M.H. designed and performed the research and edited the manuscript.

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Correspondence to Tomonori Nakazato.

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The authors declare no competing interests.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from the patients. The study was approved by the Ethics Committee of Yokohama Municipal Citizen’s Hospital.

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Nakazato, T., Hagihara, M., Sahara, N. et al. Phase II clinical trial of personalized VCD-VTD sequential therapy using the Vulnerable Elders Survey-13 (VES-13) for transplant-ineligible patients with newly diagnosed multiple myeloma. Ann Hematol 100, 2745–2754 (2021).

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  • Multiple myeloma
  • VCD
  • VTD
  • VES-13
  • Personalized therapy