Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program

BMC Cancer

Research Article

Jingshan Zhang¹  Dena DeMarco¹  Jay Mei¹  Jian Hou²  Xin Du³  Fanyi Meng⁴  Dao-bin Zhou⁵  Xiaoyan Ke⁶  Xiao Li⁷  Depei Wu⁸  Zhen Cai⁹  Jie Jin⁹  Li Yu^1,10  Fangping Chen^1,11 

[1] Celgene Corporation, Summit, NJ, USA;Department of Hematology, Shanghai Changzheng Hospital, Shanghai, China;Guangdong General Hospital, Guangzhou, China;Nanfang Hospital of Southern Medicine University in Guangzhou, Guangzhou, China;Peking Union Medical College Hospital, Beijing, China;Peking University Third Hospital, Beijing, China;Shanghai 6th Hospital, Shanghai, China;The 1st Affiliated Hospital of Soochow University, Suzhou, China;The 1st Affiliated Hospital, Zhejiang University, Hangzhou, China;The 301 Hospital-Chinese PLA General Hospital, Beijing, China;Xiangya Hospital of Central South University, Changsha, China;

关键词: Relapsed/refractory multiple myeloma;    Chinese patients;    Lenalidomide;    Low-dose dexamethasone;    Dexamethasone;   

DOI  :  10.1186/s12885-016-2069-8

 received in 2015-09-06, accepted in 2016-01-17,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021). MM-024 was an Extended Access Program (EAP) that allowed responding patients in the MM-021 trial to continue to receive Rd, and to provide additional safety and efficacy data with longer follow-up.MethodsChinese patients with RRMM who completed ≥1 year of Rd therapy in MM-021 and who remained progression-free under Rd entered the Treatment Phase of the MM-024 EAP, continuing Rd at the same dose and schedule. Patients in MM-021 who discontinued Rd treatment or progressed were allowed to enroll in the Safety Follow-Up Phase of the MM-024 EAP. Safety data, including the incidence of second primary malignancies (SPMs), were collected for ≥5 years from the time the last on-study patient enrolled in the MM-021 trial (primary end point). Efficacy outcomes (time to progression [TTP], progression-free survival [PFS], and overall survival [OS]) were secondary end points.ResultsMedian follow-up was 38.4 months for the safety population (n = 80) and 43.3 months for the treatment cohort (n = 41). In the safety population, Grade 3–4 adverse events (AEs) occurred in 60.0 % of patients; the most common grade 3–4 AEs were neutropenia (20.0 %), decreased neutrophil count (13.8 %), and anemia (11.3 %). There was no evidence of cumulative toxicity, and no patients discontinued Rd due to AEs; 2 patients had SPMs. In the treatment cohort, median duration of response was 35.1 months, median TTP was 36.9 months, and median PFS was 36.0 months; median OS was not reached due to the low number of deaths (n = 5).ConclusionLong-term treatment with Rd has a predictable and manageable safety profile and provides sustained efficacy in Chinese patients with RRMM.Trial registrationChina State Food and Drug Administration (SFDA) registration (CTA reference numbers: 209L10808; 209L10809; 209L10810; and 209L10811) and ClinicalTrials.gov Identifier: NCT02348528. First received January 23, 2015; last updated November 12, 2015; last verified November 2015; study start date September 2012.

【 授权许可】

CC BY   
© Du et al. 2016