PMID- 33389656 OWN - NLM STAT- MEDLINE DCOM- 20210607 LR - 20210607 IS - 1865-3774 (Electronic) IS - 0925-5710 (Linking) VI - 113 IP - 3 DP - 2021 Mar TI - A study of carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma in China. PG - 422-429 LID - 10.1007/s12185-020-03044-z [doi] AB - The second-generation proteasome inhibitor carfilzomib produces superior outcomes in relapsed or refractory multiple myeloma (MM). We conducted a single-arm trial of twice-weekly carfilzomib (27 mg/m(2))-dexamethasone (Kd27) for relapsed and refractory MM in China. Kd27 was administered in 28-day cycles to 123 patients previously treated with >/= 2 other regimens, including treatment with bortezomib and an immunomodulatory drug, and refractory to their most recent therapy. Overall response rate (ORR) was the primary endpoint; progression-free survival (PFS) and overall survival (OS) were key secondary endpoints. Primary analysis was conducted when all patients received >/= 6 cycles of Kd27 or discontinued Kd27. Median age was 60 years; median number of prior regimens was 4; 74% were refractory to proteasome inhibitors and immunomodulatory drugs. ORR was 35.8% (95% CI 27.3-44.9), median PFS was 5.6 (95% CI 4.6-6.5) months, and median OS was 16.6 (95% CI 12.2-NE) months. Grade >/= 3 adverse events (AEs) occurred in 76.4% of patients. Grade >/= 3 AEs of interest included hypertension (13.8%), acute renal failure (3.3%), cardiac failure (0.8%), ischemic heart disease (0.0%), and peripheral neuropathy (0.0%); 5.7% of patients discontinued carfilzomib due to AEs. Carfilzomib-dexamethasone produced a clinically meaningful response without new safety findings in Chinese patients with previously treated MM.Trial registration: NCT03029234. FAU - Du, Juan AU - Du J AD - Department of Hematology, Shanghai Changzheng Hospital, Shanghai, China. FAU - Fang, Baijun AU - Fang B AD - Department of Hematology, Henan Cancer Hospital, Zhengzhou, Henan, China. FAU - Li, Jian AU - Li J AD - Department of Hematology, Peking Union Medical College Hospital, Beijing, China. FAU - Jin, Jie AU - Jin J AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China. FAU - Wang, Shunqing AU - Wang S AD - Department of Hematology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China. FAU - Zou, Dehui AU - Zou D AD - Department of Lymphoma and Myeloma, Institute of Hematology and Hospital of Blood Disease, Tianjin, China. FAU - Cai, Zhen AU - Cai Z AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang, China. FAU - Wang, Hongxiang AU - Wang H AD - Department of Hematology, Central Hospital of Wuhan, Wuhan, Hubei, China. FAU - Hu, Jianda AU - Hu J AD - Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, Fujian, China. FAU - Li, Wei AU - Li W AD - Department of Hematology, The First Hospital of Jilin University, Changchun , Jilin, China. FAU - Fu, Chengcheng AU - Fu C AD - Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China. FAU - Shao, Zonghong AU - Shao Z AD - Department of Hematology and Oncology, Tianjin Medical University General Hospital, Tianjin, China. FAU - Xia, Zhongjun AU - Xia Z AD - Department of Hematology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China. FAU - Liu, Peng AU - Liu P AD - Department of Hematology, Zhongshan Hospital Fudan University, Shanghai, China. FAU - Niu, Ting AU - Niu T AD - Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China. FAU - Tang, En-Tzu AU - Tang ET AD - Global Biometric Data Science, Amgen Inc., Shanghai, China. FAU - Kimball, Amy S AU - Kimball AS AD - Global Development, Amgen Inc, Thousand Oaks, CA, USA. FAU - Hou, Jian AU - Hou J AD - Department of Hematology, Shanghai Renji Hospital, 160 Pujian Road, Pudong New District, Shanghai, China. houjian@medmail.com.cn. FAU - Chen, Wenming AU - Chen W AD - Department of Hematology, Beijing Chao Yang Hospital, Capital Medical University, 8 Gongti South Road, Beijing, 100020, China. 13910107759@163.com. LA - eng SI - ClinicalTrials.gov/NCT03029234 PT - Journal Article DEP - 20210103 PL - Japan TA - Int J Hematol JT - International journal of hematology JID - 9111627 RN - 0 (Oligopeptides) RN - 72X6E3J5AR (carfilzomib) RN - 7S5I7G3JQL (Dexamethasone) SB - IM MH - Acute Kidney Injury/chemically induced MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - China MH - Combined Modality Therapy MH - Dexamethasone/administration & dosage/adverse effects MH - Drug Resistance, Neoplasm MH - Female MH - Heart Diseases/chemically induced MH - Hematopoietic Stem Cell Transplantation MH - Humans MH - Hypertension/chemically induced MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Multiple Myeloma/*drug therapy/therapy MH - Oligopeptides/administration & dosage/adverse effects MH - Peripheral Nervous System Diseases/chemically induced MH - Progression-Free Survival MH - Recurrence MH - *Salvage Therapy OTO - NOTNLM OT - Carfilzomib OT - China OT - Proteasome inhibitor OT - Relapsed and refractory multiple myeloma OT - Single-arm EDAT- 2021/01/04 06:00 MHDA- 2021/06/08 06:00 CRDT- 2021/01/03 20:42 PHST- 2020/07/02 00:00 [received] PHST- 2020/11/17 00:00 [accepted] PHST- 2020/11/16 00:00 [revised] PHST- 2021/01/04 06:00 [pubmed] PHST- 2021/06/08 06:00 [medline] PHST- 2021/01/03 20:42 [entrez] AID - 10.1007/s12185-020-03044-z [pii] AID - 10.1007/s12185-020-03044-z [doi] PST - ppublish SO - Int J Hematol. 2021 Mar;113(3):422-429. doi: 10.1007/s12185-020-03044-z. Epub 2021 Jan 3.