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学科主题: 临床医学
题名:
A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial
作者: Hou, Jian1; Du, Xin2; Jin, Jie3; Cai, Zhen3; Chen, Fangping4; Zhou, Dao-bin5; Yu, Li6; Ke, Xiaoyan7; Li, Xiao8; Wu, Depei9; Meng, Fanyi10; Ai, Huisheng11; Zhang, Jingshan12; Wortman-Vayn, Honeylet12; Chen, Nianhang12; Mei, Jay12; Wang, Jianmin13
关键词: Relapsed/Refractory Multiple Myeloma ; Chinese Patients ; Lenalidomide ; Low-dose Dexamethasone
刊名: JOURNAL OF HEMATOLOGY & ONCOLOGY
发表日期: 2013-06-19
DOI: 10.1186/1756-8722-6-41
卷: 6
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology ; Hematology
研究领域[WOS]: Oncology ; Hematology
关键词[WOS]: DEEP VENOUS THROMBOSIS ; RENAL IMPAIRMENT ; SALVAGE THERAPY ; THALIDOMIDE ; COMBINATION ; BORTEZOMIB ; SURVIVAL ; THROMBOEMBOLISM
英文摘要:

Background: There is an unmet need for treatment options in Chinese patients with relapsed or refractory multiple myeloma (RRMM). Lenalidomide plus low-dose dexamethasone is effective and generally well tolerated in Caucasian RRMM patients, but no previous study has evaluated this regimen in Chinese RRMM patients.

Methods: MM-021 is a phase 2, multicenter, single-arm open-label registration trial conducted to assess the efficacy, safety, and pharmacokinetics of lenalidomide plus low-dose dexamethasone in Chinese patients with RRMM. Patients with >= 1 prior antimyeloma therapy received lenalidomide plus low-dose dexamethasone until disease progression or discontinuation. Follow-up of surviving patients continued for >= 1 year after enrollment. The lenalidomide dose was 25 mg/day, and was adjusted according to baseline renal function. Most patients had advanced disease (85.6% had Durie-Salmon stage III) and were heavily pretreated (56.7% had received >= 4 prior regimens; 69.5% prior thalidomide and 63.1% prior bortezomib); 5.3% had immunoglobulin D (IgD) disease.

Results: The safety population comprised 199 eligible patients. In the efficacy population (n = 187), the disease control rate (at least stable disease) was 94.7%, and the overall response rate (at least partial response) was 47.6%. High response rates were also achieved in patients who had renal impairment and in those with IgD disease. After a median study follow-up of 15.2 months, the median response duration was 8.8 months (range, 0.4-18.8 months) and median progression-free survival was 8.3 months (95% CI 6.5-9.8). The most common grade 3-4 adverse events (AEs) were anemia (26.1%), neutropenia (25.1%), thrombocytopenia (14.6%), pneumonia (13.1%), leukopenia (9.5%), and decreased neutrophil count (8.5%). AEs led to lenalidomide dose reduction and/or interruption in 40.2% of patients, and treatment discontinuation in about 9% of patients. The pharmacokinetic profile of lenalidomide was similar to that reported in Caucasian and Japanese patients.

Conclusions: Lenalidomide plus low-dose dexamethasone was associated with a high response rate and acceptable safety profile in heavily pretreated Chinese patients with RRMM, including those with renal impairment and IgD subtype. These findings highlight the clinical potential of this regimen in Chinese RRMM patients who have exhausted current treatment options.

Trial registration: China State Food and Drug Administration (SFDA) registration (CTA reference numbers: 209 L10808; 209 L10809; 209 L10810; and 209 L10811) and ClinicalTrials.gov identifier: NCT01593410.

语种: 英语
项目资助者: Celgene Corporation
WOS记录号: WOS:000321206800001
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/60473
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: 1.Guangdong Gen Hosp, Guangzhou, Guangdong, Peoples R China
2.Cent S Univ, Xiangya Hosp, Changsha, Hunan, Peoples R China
3.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
4.Shanghai 6th Hosp, Shanghai, Peoples R China
5.Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China
6.307 PLA Hosp, Beijing, Peoples R China
7.Celgene Corp, Summit, NJ USA
8.Changhai Hosp, Shanghai, Peoples R China
9.Shanghai Changzheng Hosp, Dept Hematol, Shanghai 200003, Peoples R China
10.Zhejiang Univ, Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
11.Beijing Union Med Coll Hosp, Beijing, Peoples R China
12.Chinese Peoples Liberat Army Gen Hosp, Hosp 301, Beijing, Peoples R China
13.Southern Med Univ Guangzhou, Nanfang Hosp, Guangzhou, Guangdong, Peoples R China

Recommended Citation:
Hou, Jian,Du, Xin,Jin, Jie,et al. A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial[J]. JOURNAL OF HEMATOLOGY & ONCOLOGY,2013,6.
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