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[A multicenter, prospective, phaseⅡ, single-arm study on the treatment of newly diagnosed multiple myeloma with domestic bortezomib in combination with lenalidomide and dexamethasone].
Xie, L N; Wang, X; He, Q; Wang, H; Ma, J; Zhang, H Y; Liu, N; Jie, G T; Xiao, T W; Zhang, H; Zhang, H G; Li, Z J; Xing, L J.
Afiliação
  • Xie LN; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • Wang X; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • He Q; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • Wang H; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • Ma J; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • Zhang HY; Department of Hematology, Linyi City People's Hospital, Linyi 276003, China.
  • Liu N; Department of Hematology, Heze City Hospital, Heze 274031, China.
  • Jie GT; Department of Hematology, Linyi Central Hospital, Linyi 276400, China.
  • Xiao TW; Department of Hematology, Liaocheng City People's Hospital, Liaocheng 252000, China.
  • Zhang H; Department of Hematology, Jining Medical University Affiliated Hospital, Jining 272100, China.
  • Zhang HG; Department of Hematology, Jining First People's Hospital, Jining 272011, China.
  • Li ZJ; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
  • Xing LJ; Department of Lymphohematology, Cancer Hospital of Shandong First Medical University, Shandong Cancer Hospital, Jinan 250000, China.
Zhonghua Xue Ye Xue Za Zhi ; 45(6): 571-576, 2024 Jun 14.
Article em Zh | MEDLINE | ID: mdl-39134489
ABSTRACT

Objective:

To explore the efficacy and safety of domestic bortezomib in combination with lenalidomide and dexamethasone in the treatment of newly diagnosed multiple myeloma (NDMM) .

Methods:

This multicenter, prospective, single-arm clinical study included 126 patients with NDMM admitted to seven hospitals between December 2019 and January 2022. All patients received domestic bortezomib in combination with lenalidomide and dexamethasone (BLD regimen), and the efficacy, prognostic factors, and safety were analyzed.

Results:

Among the 126 patients with NDMM, 118 completed four cycles of treatment, with an overall response rate (ORR) of 93.22% (110/118) and a ≥very good partial response (VGPR) rate of 68.64% (81/118). Ultimately, 114 patients completed at least eight cycles of treatment, with an ORR of 92.98% (106/114) and a ≥VGPR rate of 77.19% (88/114). Eighteen patients underwent autologous hematopoietic stem cell transplantation after completing 6-8 cycles of the BLD regimen, with an ORR of 100% (18/18) and a ≥VGPR rate of 88.9% (16/18). The proportion of patients achieving ≥VGPR increased with the treatment duration, and factors such as staging and age did not significantly affect efficacy. Single-factor analysis showed that R2-ISS stage Ⅲ/Ⅳ, blood calcium >2.27 mmol/L, and failure to achieve VGPR after six cycles were adverse prognostic factors for progression-free survival (PFS) (P<0.05), whereas failure to achieve VGPR after six cycles was an adverse prognostic factor for overall survival (OS) (P<0.001). Multifactor analysis demonstrated that failure to achieve VGPR after six cycles is an independent adverse prognostic factor for PFS (P=0.002). The incidence of hematologic adverse reactions was 16.7% (19/114), and nonhematologic adverse reactions were mainly mild to moderate, with no significant cardiac or renal adverse reactions observed.

Conclusion:

The BLD regimen is effective in treating NDMM, in which patients with high-risk genetic features are still achieving a high ≥VGPR rate, and the overall safety is good.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dexametasona / Protocolos de Quimioterapia Combinada Antineoplásica / Bortezomib / Lenalidomida / Mieloma Múltiplo Limite: Female / Humans / Male / Middle aged Idioma: Zh Revista: Zhonghua Xue Ye Xue Za Zhi Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dexametasona / Protocolos de Quimioterapia Combinada Antineoplásica / Bortezomib / Lenalidomida / Mieloma Múltiplo Limite: Female / Humans / Male / Middle aged Idioma: Zh Revista: Zhonghua Xue Ye Xue Za Zhi Ano de publicação: 2024 Tipo de documento: Article País de afiliação: China