The CACA Guidelines was summarized by Hematology Oncology Committee of China Anti- Cancer Association. This portion of the CACA Guidelines for adult acute myeloid leukemia (AML) not only focuses on diagnosis, the treatment options for younger (age < 60 years) and older (age ≥ 60 years) patients (including non-APL, APL, R/R AML), but also pay attention to the treatment of AML complications, including central nervous system leukemia (CNSL), cardiotoxicity, agranulocytosis and fever, hepatitis B virus reactivation, uric acid nephropathy, bleeding and coagulation disorders, and nursing for patients with AML from the perspective of holistic integrative medicine to enhance the quality of life and treatment effects.

Diffuse large B cell lymphoma (DLBCL) is the most common aggressive lymphoid malignancy, with an immunosuppressive microenvironment affecting clinical outcome. Interleukin (IL)‐13 overexpression is observed in multiple solid tumors and contributes to tumor progression. This study aims to investigate pretreatment serum IL‐13 levels and their relationship with the prognosis of DLBCL patients. One hundred and sixty‐six patients with newly diagnosed DLBCL from June 2015 to July 2017 were included. Patients with elevated pretreatment serum IL‐13 levels (IL‐13≥1.63 pg/ml) were classified into the high IL‐13 group and they had significantly lower complete remission rate (60% vs. 74%, p = 0.0059), higher progression rate (43% vs. 23%, p = 0.0051), and poor progression‐free survival (2‐year PFS, 63% vs. 78%, p = 0.0078) and overall survival (2‐year OS, 75% vs. 92%, p = 0.0027), when compared to those in the low IL‐13 group (IL‐13<1.63 pg/ml). Meanwhile, increased Treg cell ratio in peripheral blood ( p = 0.0147) and elevated serum IL‐2 levels ( p = 0.0272) were observed in the high IL‐13 group. Moreover, RNA sequencing data showed that patients in the high IL‐13 group had significantly elevated expression of chemokines and chemokine receptors (CCR4, CCL19, CCL21, CXCL2) related to Treg activation and recruitment. Consistent with the chemokine profile, tumor immunophenotyping analysis revealed that higher Treg cells recruitment in the high IL‐13 group than the low IL‐13 group ( p = 0.0116). In vitro, when lymphoma cells co‐cultured with peripheral blood monocytes of healthy controls, metformin down‐regulated both IL‐13 level and Treg cell ratio, in consistent with the decreased serum IL‐13 levels of patients after 6 months of metformin maintenance therapy in the high IL‐13 group. Taken together, pretreatment serum IL‐13 level is related to the immunosuppressive microenvironment and poor clinical outcome of DLBCL patients and could be targeted by metformin, thus providing a new therapeutic strategy in treating DLBCL with high serum IL‐13 levels.

Targeted therapy with Bruton tyrosine kinase (BTK) inhibitors have revolutionized the treatment of patients with various B-cell malignancies. BTK inhibitors such as ibrutinib, zanubrutinib, orelabrutinib, and acalabrutinib have shown good clinical efficacy and better safety profiles than those of traditional chemotherapy and chemoimmunotherapy regimens. Multiple studies on new BTK inhibitors are ongoing, which may provide more therapeutic options for the treatment of B-cell malignancies. Considering the unmet need of evidence on BTK inhibitors in all clinical settings and to standardize the use of BTK inhibitors available in mainland China, Taiwan, Hong Kong, and Macau regions, this consensus has been formulated for the treatment of various B-cell malignancies based on the clinical practice and available evidences on the use of BTK inhibitors. The recommendations of this consensus will provide guidance to physicians and clinical researchers on the effective treatment of B-cell malignancies with BTK inhibitors.

目的·总结接受伊马替尼治疗后符合停药标准的慢性髓系白血病(chronic myeloid leukemia,CML)慢性期(chronic phase,CP)患者在规范监测下尝试无治疗缓解(treatment-free remission,TFR)的结局,并分析可能影响TFR的预后因素和微滴式数字聚合酶链式反应(droplet digital polymerase chain reaction,ddPCR)在TFR监测中的作用.方法·对入组CML-CP患者在停药后定期进行规范监测.通过定量聚合酶链式反应(quantitative polymerase chain reaction,QPCR)检测BCR-ABL转录本评估分子学反应和复发;采用流式细胞仪检测淋巴细胞亚群,分析其对TFR的影响;采用ddPCR检测BCR-ABL,分析其在TFR中的预示作用.结果·①42例符合停药标准的CML-CP患者,中位随访时间41(5～93)个月;32例(76.2％)患者仍维持TFR状态.12、24和48个月的预期TFR率分别为85.1％、75.1％和70.1％.中位TFR时间为41(2～93)个月.停药后最常见的不良反应为肌肉关节疼痛(31.0％),均为Ⅰ～Ⅱ级.可评估的8例重启治疗患者100％达深层次分子学反应(deep molecular response,DMR).②停药后持续ddPCR阳性的患者中,7例(58.3％)出现分子学复发,而ddPCR结果为阴性的患者均未出现复发(P＜0.01).③停药前复发组的CD8+CD28-细胞百分比低于TFR组(6.2％vs 12.6％,P=0.026),停药后复发组CD4+CD25+细胞百分比高于TFR组(3.2％vs 2.1％,P=0.021).结论·长期持续接受伊马替尼治疗,并符合停药标准的CML-CP患者可以获得持续的TFR;ddPCR有助于提示TFR的预后,并更早识别可能发生分子学复发的患者;不同的T细胞亚群可能在TFR过程中参与了免疫调节以防止CML疾病复发.

哺乳期妇女发生的乳腺脓肿称为哺乳期脓肿,是一种常见的乳腺脓肿.发病初期患者临床症状不甚严重,多数患者采用负压吸乳器或乳房按摩.但由于乳腺内乳汁出现淤积,导致乳腺管内细菌感染,使患者表现出乳腺肿胀、疼痛等不适症状.尤其在病情发展阶段,乳腺出现感染化脓症状,而金黄色葡萄球菌是较为多见的乳腺脓肿致病菌之一,一旦感染可对乳腺管、乳腺实质造成直接影响.对于哺乳期脓肿的治疗,临床常用乳脓肿切开引流术方式,但是需要较长的换药时间,伤口愈合十分缓慢,容易增加术后并发症的发生概率,对患者的生活带来不利影响.在医疗技术水平日益提升的今天,超声引导作用下,介入治疗方式已经完全取代手术切开引流术,但是引流不通,依旧能够使乳腺脓肿病症反复发作,且负压封闭引流术有着平稳负压连续引流的优势作用,能够将坏死组织彻底清除,并在引流作用下,持续保持"零积液"状态,使创面达到连续清洁的效果,有助于形成不利于细菌生长繁殖的外部环境,从而降低毒素、坏死毒素对于正常组织细胞的不利影响.随着对哺乳期乳腺脓肿的研究愈发深入,也使《实用临床普通外科学》一书走进临床医师的视野当中,此书中对于治疗哺乳期乳腺脓肿的研究颇为详细,尤其是超声辅助定位负压封闭引流技术+敏感抗生素冲洗联合治疗方法,效果十分明显.

Chidamide has demonstrated significant clinical benefits for patients with relapsed/refractory (R/R) PTCL in previous studies. This multi-center observational study was aimed to evaluate the objective response rate (ORR), overall survival (OS), and safety of chidamide. From February 2015 to December 2017, 548 patients with R/R PTCL from 186 research centers in China were included in the study. Among the 261 patients treated with chidamide monotherapy, ORR was 58.6% and 55 patients (21.1%) achieved complete response (CR). Among the 287 patients receiving chidamide-containing combination therapies, ORR was 73.2% and 73 patients (25.4%) achieved CR. The median OS of all patients was 15.1 months. The median OS of patients receiving chidamide monotherapy and combination therapies was 433 and 463 days, respectively. These results demonstrate a significant survival advantage of chidamide treatments as compared with international historical records. Common adverse effects (AEs) were hematological toxicities. Most AEs in both monotherapy and combined treatments were grade 1–2. No unanticipated AEs occurred. In conclusion, chidamide-based therapy led to a favorable efficacy and survival benefit for R/R PTCL. Future studies should explore the potential advantage of chidamide treatment combined with chemotherapy.

目的:探究纵隔肿块起病的淋巴瘤患者临床特征以及预后分析.方法:回顾性收集2010年1月至2021年4月收治的151例以纵隔肿块起病的淋巴瘤患者临床资料,采用Kaplan-Meier方法计算生存期,并采用COX模型进行预后因素分析.结果:纳入研究的151例患者中,男76例,女75例,中位年龄32岁.按照病理分型分析,44例(29.1％)霍奇金淋巴瘤,35例(23.2％)弥漫大B细胞淋巴瘤,32例(21.2％)原发纵隔大B细胞淋巴瘤,32例(21.2％)淋巴母细胞淋巴瘤,3例(2.0％)成熟外周T细胞淋巴瘤,3例(2.0％)灰区淋巴瘤,2例(1.3％)黏膜相关淋巴组织淋巴瘤.肿块侵犯部位以前纵隔居多(140例,92.7％),其次为前中纵隔(7例,4.6％),后纵隔(2例,1.3％)和后中纵隔(2例,1.3％).根据病理类型进行生存分析,霍奇金淋巴瘤患者的预后最佳,3年无进展生存率和3年总生存率分别为93.2％和100.0％.多因素分析发现,疾病分期晚(Ⅲ～Ⅳ期)是影响患者无进展生存(P=0.0051)和总生存(P=0.0337)的独立预后不良因素.结论:纵隔肿块起病的淋巴瘤以霍奇金淋巴瘤、弥漫大B细胞淋巴瘤、原发纵隔弥漫大B细胞淋巴瘤和淋巴母细胞淋巴瘤这几种病理亚型为主,侵犯部位主要为前纵隔,在这些亚型中,霍奇金淋巴瘤预后最佳.

Abstract. Background:. Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment. Methods:. This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR. Results:. A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%–81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities. Conclusion:. Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients. Clinical trial registration:. ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621

Objective: To analyze the correlation between plasma trough level of generic imatinib and its metabolism and clinical outcomes in Chinese patients with chronic myeloid leukemia in chronic phase (CML-CP) . Methods: The 21 patients with CML-CP who enrolled in a clinical trial YMTN 1.0 from Oct 11(th), 2012 to May 8(th), 2013 and received generic imatinib were as study subjects. The correlation between steady plasma trough levels of imatinib and its metabolism with clinical response, age, weight and body surface area (BSA) were evaluated. Results: ①The mean steady plasma trough level of generic imatinib and its metabolism was (1 185.07±417.91) μg/L and (251.53±76.50) μg/L, respectively. ②Age, weight and BSA has no significant effects on plasma trough level of generic imatinib and its metabolism (P>0.05) . ③Patients with steady plasma trough level of generic imatinib more than 1 000 μg/L are possible to have higher major molecular response (MMR) /complete molecular response (CMR) rate than those below 1 000 μg/L (42% vs 0, P<0.05) . Conclusion: Plasma trough levels of generic imatinib varied in CML patients. The steady plasma trough levels of generic imatinib is maybe related to molecular response in CML patients.

目的:分析腹腔镜肠系膜下动脉低位结扎对直肠癌术后吻合口漏和预后的影响.方法:在2017年11月-2018年11月我院进行腹腔镜直肠癌手术患者中随机选取100例,其中50例患者接受动脉高位结扎,为对照组,其余50例接受腹腔镜肠系膜下动脉低位结扎,为研究组,对比两组术后吻合口漏发生率以及患者住院时间.结果:两组数据对比,研究组吻合口漏发生率和患者住院时间均比对照组少,差异存在统计学意义(P<0.05).结论:对进行腹腔镜直肠癌手术的患者可以采取动脉低位结扎,有利于减少术后吻合口漏发生数量,促进患者康复.

Background: Imatinib is the first TKI that was officially approved by the Food and Drug Administration (FDA) for the treatment of patients (pts) with CP-CML and it is the most commonly used treatment in CML pts on the international scene. Generic imatinib was offered and accessible as frontline treatment of CML in china in June 2013, which predictably lowered the cost of CML therapy. However the statistics regarding their effectiveness and tolerability in greater proportion of the population of CML pts are not available. (ClinicalTrials. gov number, NCT02317159.) Aim: To evaluate the efficacy and safety of generic imatinib in the treatment of pts that were newly diagnosed with CP-CML. Methods: In this multi-center, prospective open-label study, 75 pts with CP-CML were enrolled to receive generic imatinib mesylate capsules at a dose of 400 mg once daily. The primary end point was major molecular response (MMR) by 12 months. Imatinib plasma level and adverse events (AEs) were assessed. Results: The Median age at diagnosis was 46 years (range 19-75 years), and 50 pts (66.7%) were male. The median follow-up was 22.1 (range0.5-24) months. 35 pts (44%), 26 pts (34.7%) and 12 pts (16%) were in low, intermediate and high risk group, respectively, according to Sokal prognostic score (Not available in 2 pts). By 12 months, the cumulative rate of MMR (BCR-ABL1IS ≤0.1%) was 42.7% (32/75), and the cumulative rate of complete cytogenic response (CCyR) was74.7% (56/75). Complete hematologic response (CHR), CCyR, MMR rate at 3 months,6 months and 12 months were shown in Table 1. For pts who presented with BCR-ABL1 IS≤ 10% at 3 months, had better response as compared with those with BCR/ABL1IS> 10% (Table 2). The estimated progression-free survival at 12 months was 94.7%. Imatinib plasma levels at 29 days on imatinib were variable in individual, with 1522.9±775.3 ng/mL for median level (rang 394.4 to3891 ng/mL). Although those numerical values showed difference, no statistically significant correlations were found between imatinib plasma level and CCyR or MMR(P=0.902;P=0.349). The incidents and profile of AEs were similar to those reported previously. Conclusion: This study confirmed that generic imatinib produced in China is effective and well-tolerated in Chinese CP-CML pts. The outcome of generic imatinib in the treatment of CP-CML is similar to brand imatinib reported in the literatures. The introduction of generic imatinib at a reduced and affordable cost may strikingly impact the cost of care for CML and improve the clinical outcomes of CML in China. Disclosures No relevant conflicts of interest to declare.

B幼淋巴细胞白血病(B-prolymphocytic leukemia,B-PLL)是一种非常罕见的成熟B淋巴细胞增殖性疾病,仅占所有白血病的1％左右,在淋巴细胞白血病中所占比例不足2％,主要发生于60岁以上老年人,中位发病年龄接近69岁,男性略多于女性.B-PLL临床表现大多呈侵袭性,包括脾肿大和白细胞计数升高,外周血淋巴细胞计数增高,以幼淋巴细胞比例超过55％为特征,并且临床预后不佳[1].B-PLL和其他几种B淋巴细胞增殖性疾病如慢性淋巴细胞白血病(chronic lymphoblastic leukemia,CLL)、套细胞淋巴瘤(mantle cell lymphoma,MCL)及毛细胞性白血病(hairy cell leukemia,HCL)等在临床表现及实验室检查方面常常难以鉴别.现报告1例B-PLL患者的临床资料,并通过文献复习总结B-PLL的诊断标准,以提高临床医师对该病的诊疗水平.

OBJECTIVES:The arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA) therapy has demonstrated a tremendous success in the first-line treatment of acute promyelocytic leukemia (APL). Actually, early death (ED) is currently thought as a major challenge in APL. ATO has been reported to inhibit platelet function in vitro, and whether it increases the ED rate by exacerbating the hemorrhagic symptoms remains to be investigated. METHODS:Effects of ATO on platelet aggregation and adhesion were evaluated in vitro and in thirty-two complete remission (CR) and four newly diagnosed APL patients. Furthermore, concentrations of plasma total arsenic were monitored in APL patients via ICP-MS. RESULTS:The inhibition of platelet function, either aggregation or adhesion, did occur in vitro when the concentration of ATO reached 2 μmol/L. However, in CR APL patients receiving ATO with normal platelet count, the platelets responded normally when being activated and so did those in the newly diagnosed patients with thrombocytopenia. Our data further showed that the conventional dosage of ATO reached a plasma concentration substantially below the required concentration to inhibit platelets. CONCLUSIONS:In the first-line treatment of APL, the use of ATO is safe and effective and does not compromise the hemostatic potential that may eventually increase ED rate.

Objective The aim of this study was to evaluate the effects of aerobic exercise on AGE-RAGE axis and nuclear factor kappa B pathway in type 2 diabete rats and to discuss the rehabilitation function of aerobic exercise in type 2 diabetes mellitus (T2DM) . Methods After the 8-week-old male Wistar rats were fed with a high sugar and high fat for 4 weeks, type 2 diabetes rats were induced by streptozotocin way. 30 type 2 diabetes rats were allocated at random into 3 groups:type 2 diabetes mellitus (T2DM), low- and moderate- intensity exercise groups (T2DML, T2DMM) . Exercise group performed exercise protocol respectively. The AGEs, RAGE and NF-κB levels of the blood,muscle and heart were detected by ELISA method respectively. Results Compared with T2DM group, the NF-κB level of the blood, muscle and heart were decreased in T2DML group significantly (P<0.05);the AGEs, RAGE and NF-κB level of the blood, muscle and heart were decreased in T2DMM group significantly ( <0.05) . Compared with T2DML group, the NF-κB level of the blood, muscle and heart were decreased in T2DMM group significantly ( <0.05) . Conclusion Moderate intensity aerobic exercise inhibits AGE-RAGE axis and NF-κB pathway, which may decrease oxidative stress and inflammation, and so reduce tissue injure for the prevention and treatment of complications of the T2DM.

Dasatinib is a highly effective second-generation tyrosine kinase inhibitor used to treat chronic myeloid leukemia (CML). In 2007, a pivotal phase-2 study of dasatinib as second-line treatment was initiated in 140 Chinese CML patients. This report from the 4-year follow-up revealed that 73% of 59 patients in chronic phase (CML-CP) and 32% of 25 patients in accelerated phase (CML-AP) remained under treatment. The initial dosage of dasatinib for CML-CP and CML-AP patients were 100 mg once daily and 70 mg twice daily (total = 140 mg/ day), respectively. The cumulative major cytogenetic response (MCyR) rate among patients with CML-CP was 66.1% (versus 50.8% at 18 months), and the median time to MCyR was 12.7 weeks. All CML-CP patients who achieved MCyR after a 4-year follow-up also achieved a complete cytogenetic response. The cumulative complete hematological response (CHR) rate among patients with CML-AP was 64% (16/25), with three CML-AP patients achieving CHR between 18 months and 4 years of follow-up; the median time to CHR was 16.4 weeks. The adverse event (AE) profile of dasatinib at 4 years was similar to that at 6 and 18 months. The most frequently reported AEs (any grade) included pleural effusion, headache, and myelosuppression. These long-term follow-up data continue to support dasatinib as a second-line treatment for Chinese patients with CML.

Patients with relapsed/refractory B-cell lymphomas have limited treatment options. GERSHWIN is an open-label, single-arm, phase Ib study of obinutuzumab monotherapy in Chinese patients with histologically documented CD20+ relapsed/refractory chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), or follicular lymphoma (FL). The primary outcome measure of pharmacokinetics has been previously reported. We now present data on the secondary endpoint measures (e.g., safety, and efficacy and pharmacodynamics).

BACKGROUND:Azacitidine safety and efficacy were established in studies of mainly Caucasian patients. Differences in drug metabolism enzymes between Caucasian and East Asian populations prevent extrapolation of drug effects between these groups. This phase 2 study evaluated azacitidine safety, efficacy and pharmacokinetics in patients with higher-risk myelodysplastic syndromes (HR-MDS) in mainland China.METHODS:Patients aged ≥18 years with HR-MDS were to receive subcutaneous azacitidine 75 mg/m2 /day for 7 days per 28-day cycle, for ≥6 cycles. Pharmacokinetic blood samples were collected in cycle 1 predose on days 5-7, and postdose on day 7. Pharmacokinetic outcomes are descriptively compared with those of a historical North American cohort.RESULTS:Of 72 participants, 46 (64%) completed ≥6 cycles. Response rate was 96%, driven primarily by stable disease (94%); one patient achieved complete remission. Hematologic improvement was attained by 53% of patients. Azacitidine mean plasma concentration versus time profiles were similar in shape for Chinese (n = 12) and North American (n = 45) patients. Maximum plasma concentration (Cmax ) was higher in Chinese patients; however, mean azacitidine exposure (1190 ng·h/mL) was similar to the North American cohort (1021 ng·h/mL). Most common grade 3-4 treatment-emergent adverse events (TEAEs) were thrombocytopenia (69%) and neutropenia (67%).CONCLUSIONS:Azacitidine was safe and effective in Chinese patients with HR-MDS. Clinical outcomes were comparable to those for primarily Caucasian patients in the phase 3 AZA-001 study. Cmax differences between Chinese and North American patients were not associated with differences in TEAE frequency or severity. No initial azacitidine dose adjustment is required for Chinese patients with HR-MDS.

Despite advances in the treatment of T-cell acute lymphoblastic leukemia (T-ALL), the outcome of T-ALL treatment remains unsatisfactory, therefore, more effective treatment is urgently required. The present study examined the cytotoxicities of bortezomib in combination with daunorubicin against human Jurkat and Molt-4 T-ALL cells and primary T-ALL cells. Compared with treatment alone, co-exposure of cells to bortezomib and daunorubicin resulted in a significant increase in cell death in the Jurkat cells, as evidenced by the increased percentage of Annexin V-positive cells, the formation of apoptotic bodies. In addition, the administration sequence of bortezomib and daunorubicin had an effect on cell viability. Treatment with bortezomib followed by daunorubicin treatment was more effective, compared with treatment with daunorubicin followed by bortezomib. Co-treatment with bortezomib and daunorubicin markedly enhanced the activation of caspase-3, -8 and -9, which was reversed by the pan-caspase inhibitor, Z-VAD-FMK. In addition, cotreatment with bortezomib and daunorubicin enhanced the collapse of mitochondrial transmembrane potential and upregulated the proapoptotic protein, B-cell lymphoma 2 (Bcl-2) -interacting mediator of cell death (Bim), but not Bcl-2 or Bcl-extra large. Consistent with this, it was demonstrated that cotreatment of bortezomib and daunorubicin efficiently induced apoptosis in primary T-ALL cells, and cell death was associated with the collapse of mitochondrial transmembrane potential and the upregulation of Bim. Taken together, these findings indicated that the combination of bortezomib and daunorubicin significantly enhanced their apoptosis-inducing effect in T-ALL cells, which may warrant further investigation in preclinical and clinical investigations.

Purpose Circularly permuted TRAIL (CPT) has exhibited promising efficacy as a mono-therapy or in combination with thalidomide for patients with multiple myeloma (MM). In this phase 2 study, the safety and efficacy of CPT in combination with thalidomide and dexamethasone (CPT+TD) was evaluated in patients with pretreated relapsed/refractory MM (RRMM).Methods Patients who received at least two previous therapies for MM were randomly assigned at a 2: 1 ratio to receive treatment with CPT + TD or thalidomide and dexamethasone (TD). The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), duration of response (DOR) and safety.Results Overall, 47 patients were assigned to the CPT + TD group, and 24 patients were recruited to the TD group. The ORR in the CPT + TD group was 38.3 vs. 25.0% in the TD group. The median PFS time was 6.7 months for the CPT + TD group and 3.1 months for the TD group. The median DORs for the CPT + TD and TD groups were 7.1 and 3.2 months, respectively. Most of the adverse effects (AEs) were grade 1 or 2. Serious AEs were reported in 19.7% of the patients. No treatment-related deaths were reported.Conclusion CPT plus TD could serve as a new therapeutic strategy for patients with RRMM.A randomized, doubleblind, placebo-controlled confirmatory study is currently under way.