PMID- 26821931 OWN - NLM STAT- MEDLINE DCOM- 20161005 LR - 20181202 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 16 DP - 2016 Jan 28 TI - Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program. PG - 46 LID - 10.1186/s12885-016-2069-8 [doi] LID - 46 AB - BACKGROUND: The 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. METHODS: Chinese 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. RESULTS: Median 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). CONCLUSION: Long-term treatment with Rd has a predictable and manageable safety profile and provides sustained efficacy in Chinese patients with RRMM. TRIAL REGISTRATION: China 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. FAU - Du, Xin AU - Du X AD - Guangdong General Hospital, Guangzhou, China. miyadu@hotmail.com. FAU - Jin, Jie AU - Jin J AD - The 1st Affiliated Hospital, Zhejiang University, Hangzhou, China. jiej0503@163.com. FAU - Cai, Zhen AU - Cai Z AD - The 1st Affiliated Hospital, Zhejiang University, Hangzhou, China. caizhen1@sina.com. FAU - Chen, Fangping AU - Chen F AD - Xiangya Hospital of Central South University, Changsha, China. cnchenfp@hotmail.com. FAU - Zhou, Dao-bin AU - Zhou DB AD - Peking Union Medical College Hospital, Beijing, China. zhoudb@pumch.cn. FAU - Yu, Li AU - Yu L AD - The 301 Hospital-Chinese PLA General Hospital, Beijing, China. liyu301@vip.163.com. FAU - Ke, Xiaoyan AU - Ke X AD - Peking University Third Hospital, Beijing, China. xykbysy@163.com. FAU - Li, Xiao AU - Li X AD - Shanghai 6th Hospital, Shanghai, China. lixiao3326@yahoo.com.cn. FAU - Wu, Depei AU - Wu D AD - The 1st Affiliated Hospital of Soochow University, Suzhou, China. wudepei@medmail.com.cn. FAU - Meng, Fanyi AU - Meng F AD - Nanfang Hospital of Southern Medicine University in Guangzhou, Guangzhou, China. mengfu@medmail.com.cn. FAU - DeMarco, Dena AU - DeMarco D AD - Celgene Corporation, Summit, NJ, USA. ddemarco@celgene.com. FAU - Zhang, Jingshan AU - Zhang J AD - Celgene Corporation, Summit, NJ, USA. jizhang@celgene.com. FAU - Mei, Jay AU - Mei J AD - Celgene Corporation, Summit, NJ, USA. jmei@celgene.com. FAU - Hou, Jian AU - Hou J AD - Department of Hematology, Shanghai Changzheng Hospital, Shanghai, China. houjian@medmail.com.cn. LA - eng SI - ClinicalTrials.gov/NCT02348528 PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160128 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 4Z8R6ORS6L (Thalidomide) RN - 7S5I7G3JQL (Dexamethasone) RN - F0P408N6V4 (Lenalidomide) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols MH - China MH - Dexamethasone/*administration & dosage/adverse effects MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Drug Resistance, Neoplasm/genetics MH - Drug-Related Side Effects and Adverse Reactions/classification/*pathology MH - Female MH - Humans MH - Lenalidomide MH - Male MH - Middle Aged MH - Multiple Myeloma/*drug therapy/pathology MH - Neoplasm Recurrence, Local/*drug therapy/pathology MH - Thalidomide/administration & dosage/adverse effects/*analogs & derivatives MH - Treatment Outcome PMC - PMC4730718 EDAT- 2016/01/30 06:00 MHDA- 2016/10/07 06:00 PMCR- 2016/01/28 CRDT- 2016/01/30 06:00 PHST- 2015/09/06 00:00 [received] PHST- 2016/01/17 00:00 [accepted] PHST- 2016/01/30 06:00 [entrez] PHST- 2016/01/30 06:00 [pubmed] PHST- 2016/10/07 06:00 [medline] PHST- 2016/01/28 00:00 [pmc-release] AID - 10.1186/s12885-016-2069-8 [pii] AID - 2069 [pii] AID - 10.1186/s12885-016-2069-8 [doi] PST - epublish SO - BMC Cancer. 2016 Jan 28;16:46. doi: 10.1186/s12885-016-2069-8.