高级检索
当前位置: 首页 > 详情页

Efficacy and safety of pomalidomide and low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma: a multicenter, prospective, single-arm, phase 2 trial

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

机构: [1]Department of Hematology, Changzheng Hospital, Shanghai, China [2]Departmentof Hematology, Shanghai Fourth People’s Hospital, School of Medicine,Tongji University, Shanghai, China [3]Department of Hematology, TianjinMedical University Cancer Institute and Hospital, Tianjin, China [4]Departmentof Hematology, The Affiliated Hospital of Qingdao University, Qingdao,Shandong Province, China [5]Department of Hematology, West China Hospital,Sichuan University, Chengdu, China [6]Department of Hematology, AffiliatedCancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou,China [7]Department of Hematology, Shengjing Hospital of China MedicalUniversity, Shenyang, Liaoning, China [8]Department of Hematology, The940th Hospital of Joint Logistics Support Force of Chinese People’s LiberationArmy, Lanzhou, China [9]Department of Hematology, Peking University People’sHospital and Peking University Institute of Hematology, Beijing, China
出处:
ISSN:

关键词: Relapsed/Refractory Multiple Myeloma Chinese Patients Oral Pomalidomide Efficacy Safety

摘要:
Background: Pomalidomide in combination with dexamethasone has demonstrated positive results in patients with relapsed or refractory multiple myeloma (RRMM), but no data are available in China. We conducted a multicenter, single-arm trial to examine the efficacy and safety of bioequivalent generic pomalidomide plus low-dose dexamethasone in Chinese RRMM patients. Methods: Adult (>= 18 years of age) RRMM patients who progressed after at least two previous treatments, including bortezomib and lenalidomide, were eligible. Pomalidomide was given orally at 4 mg/day on days 1 to 21 of a 28-day cycle. Dexamethasone was given at 40 mg/day (either orally or intravenously; 20 mg/day at 75 years or older) on days 1, 8, 15, and 22 of each cycle. Treatment continued until disease progression or intolerable adverse events (AEs). The primary end point was objective response rate (ORR). Results: Seventy-four patients were enrolled between February 2017 and February 2019. All patients had progressed within 60 days of their last therapy. 74.3% of the patients were resistant to lenalidomide, 31.1% had renal insufficiency and 33.8% had high-risk cytogenetic RRMM. The median follow-up duration was 33.0 months (range 31.1-34.8 months). The ORR was 37.8% in the overall analysis, 32.7% in lenalidomide-refractory patients, 36.0% in patients with high-risk cytogenetics and 34.8% in RRMM patients with renal impairment. The median progression-free survival was 5.7 months (95% CI 3.7-8.8 months). The median overall survival was 24.3 months (95% CI 14.4-41.1 months). The most common grade 3 and 4 treatment-emergent adverse events (TEAEs) were neutropenia (63.5%), leukopenia (37.8%), thrombocytopenia (28.4%), and anemia (31.1%). Pulmonary infection (27.0%) was the most frequent grade 3 and 4 nonhematologic TEAE. No previously unreported AEs were observed. No venous thromboembolism was reported. Conclusions: Pomalidomide in combination with low-dose dexamethasone is effective and safe in Chinese RRMM patients.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2022]版:
大类 | 2 区 医学
小类 | 3 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 3 区 肿瘤学
JCR分区:
出版当年[2022]版:
Q2 ONCOLOGY
最新[2023]版:
Q2 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者:
第一作者机构: [1]Department of Hematology, Changzheng Hospital, Shanghai, China [2]Departmentof Hematology, Shanghai Fourth People’s Hospital, School of Medicine,Tongji University, Shanghai, China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

相关文献

[1]Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of LEPUS [2]Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial [3]The efficacy and safety of triplet regimens based on pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma: a systematic review and meta-analysis [4]Efficacy and safety of anti-CD38 monoclonal antibodies in patients with relapsed/refractory multiple myeloma: a systematic review and meta-analysis with trial sequential analysis of randomized controlled trials [5]Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study. [6]A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China [7]Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study [8]Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study. [9]Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT-MM301): a randomised, double-blinded, placebo-controlled, phase 3 trial [10]Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor-T-Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1)

资源点击量:46407 今日访问量:0 总访问量:3323 更新日期:2024-11-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 四川省肿瘤医院 技术支持:重庆聚合科技有限公司 地址:成都市人民南路四段55号