PMID- 35778685 OWN - NLM STAT- MEDLINE DCOM- 20220706 LR - 20220716 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 22 IP - 1 DP - 2022 Jul 1 TI - 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. PG - 722 LID - 10.1186/s12885-022-09802-y [doi] LID - 722 AB - 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. TRIAL REGISTRATION: The study is registered at Chinese Clinical Trial Registry (ChiCTR) ( ChiCTR-OIC-17013234 , first registered on 03/11/2017). CI - (c) 2022. The Author(s). FAU - Fu, Wei-Jun AU - Fu WJ AD - Department of Hematology, Changzheng Hospital, Shanghai, China. AD - Department of Hematology, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China. FAU - Wang, Ya-Fei AU - Wang YF AD - Department of Hematology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. FAU - Zhao, Hong-Guo AU - Zhao HG AD - Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China. FAU - Niu, Ting AU - Niu T AD - Department of Hematology, West China Hospital, Sichuan University, Chengdu, China. FAU - Fang, Bai-Jun AU - Fang BJ AD - Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China. FAU - Liao, Ai-Jun AU - Liao AJ AD - Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China. FAU - Bai, Hai AU - Bai H AD - Department of Hematology, The 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou, China. FAU - Lu, Jin AU - Lu J AD - Department of Hematology, Peking University People's Hospital and Peking University Institute of Hematology, Beijing, China. jin1lu@sina.com. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20220701 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 4Z8R6ORS6L (Thalidomide) RN - 7S5I7G3JQL (Dexamethasone) RN - D2UX06XLB5 (pomalidomide) RN - F0P408N6V4 (Lenalidomide) SB - IM MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Dexamethasone MH - Humans MH - Lenalidomide/therapeutic use MH - *Leukopenia/chemically induced MH - *Multiple Myeloma MH - Prospective Studies MH - Thalidomide/analogs & derivatives PMC - PMC9250185 OTO - NOTNLM OT - Chinese Patients OT - Efficacy OT - Oral OT - Pomalidomide OT - Relapsed/Refractory Multiple Myeloma OT - Safety COIS- The authors declare that they have no competing interests. EDAT- 2022/07/02 06:00 MHDA- 2022/07/07 06:00 PMCR- 2022/07/01 CRDT- 2022/07/01 23:34 PHST- 2021/12/16 00:00 [received] PHST- 2022/06/16 00:00 [accepted] PHST- 2022/07/01 23:34 [entrez] PHST- 2022/07/02 06:00 [pubmed] PHST- 2022/07/07 06:00 [medline] PHST- 2022/07/01 00:00 [pmc-release] AID - 10.1186/s12885-022-09802-y [pii] AID - 9802 [pii] AID - 10.1186/s12885-022-09802-y [doi] PST - epublish SO - BMC Cancer. 2022 Jul 1;22(1):722. doi: 10.1186/s12885-022-09802-y.