小剂量沙利度胺联合地塞米松治疗初诊多发性骨髓瘤的临床研究

目的:比较小剂量沙利度胺(thalidomide)联合地塞米松(dexamethasone) 简称TD方案, 与采用VBMCP(M2)方案(长春新碱+卡氮芥+美法仑+环磷酰胺+泼尼松)在治疗初诊多发性骨髓瘤(multiple myeloma, MM)中的临床疗效和不良反应.方法:小剂量TD方案治疗30例初诊MM(TD组),沙利度胺100~300 mg/d,连续口服,地塞米松40 mg/d在每个疗程的第1~4天口服;以30例接受VBMCP(M2)方案治疗的临床资料匹配的初诊MM作为历史匹配对照(M2组),比较2组的疗效、生存情况和不良反应.匹配标准包括年龄、临床分期和β2-微球蛋白水平.结果:TD组的总有效率为66.7%, M2组为60.0%,2组相比差异无统计学意义 (P>0.05).TD组中位无疾病进展生存时间(progression free survival, PFS)为13个月,M2组的中位PFS为10个月,2组相比差异无统计学意义 (P>0.0 5).与TD组相比,M2组3级以上的中性粒细胞减少、血小板降低及周围神经病变等不良反应明显增多(P<0.05).结论:对于初诊MM的一线治疗,小剂量TD方案被认为是患者能耐受的有效的口服替代方法,值得临床研究和推广应用.     

硼替佐米和沙利度胺联合VAD方案治疗多发性骨髓瘤疗效分析

目的探讨硼替佐米、沙利度胺联合VAD方案治疗多发性骨髓瘤（MM）的临床疗效。方法 18例初诊MM患者采用硼替佐米、沙利度胺联合VAD方案治疗（A组）,硼替佐米1.3 mg/m2,沙利度胺从100 mg/d开始口服,逐渐增加剂量,至200 mg/d。单纯使用VAD方案（B组）治疗的23例初诊MM患者作为对照组。结果 A组的治疗有效率优于B组（P〈0.05）,联合治疗组的不良反应有皮疹、便秘、神经毒性、乏力、嗜睡、脱发及感染。结论硼替佐米和沙利度胺联合VAD方案治疗MM疗效明显优于VAD方案,缓解率高,对于初诊性MM是疗效较好而又较安全的方案,在选择化疗方案时可优先考虑。     

小剂量沙利度胺联合含单周地塞米松的VAD方案治疗多发性骨髓瘤42例

目的观察小剂量沙利度胺联合含单周地塞米松的VAD方案治疗多发性骨髓瘤（MM）的临床疗效及不良反应。方法给予42例MM患者小剂量沙利度胺（150～200）mg／d联合含单周地塞米松（40mg,口服,第1天至第4天）的VAD方案治疗,28d为1个疗程。4个疗程后进行总体评估。结果总有效率为80．95％（34／42）;其中完全缓解6例,部分缓解20例,进步8例,无效8例。不良反应轻微,患者治疗前后血红蛋白、骨髓浆细胞比例、β2微球蛋白、Karnofsky评分、血肌酐、血免疫球蛋白差异均有统计学意义（均P〈0．001）。结论小剂量沙利度胺联合含单周地塞米松的VAD方案治疗MM有效率高,不良反应轻微,值得临床进一步研究和推广应用。     

低剂量沙利度胺联合VAD方案治疗多发性骨髓瘤25例

 目的　探讨低剂量沙利度胺联合VAD方案治疗多发性骨髓瘤（MM）的疗效及不良反应。方法　确诊的MM患者25例，沙利度胺100 mg／d，每晚睡前口服；VAD方案：长春新碱0.5 mg／d静脉滴注，第1天至第4天，多柔比星10 mg／d静脉滴注，第1天至第4天，地塞米松40 mg／d口服，第1天至第4天、第9天至第12天、第17天至第20天，每月1个疗程，共6个疗程。结果　21例患者完成了6个疗程，完全缓解5例（23.8 %），部分缓解14例（66.7 %），未缓解2例（9.5 %），总有效率90.5 %。沙利度胺的主要不良反应为乏力、便秘、水肿、末梢神经炎，对症处理后可耐受。结论　低剂量沙利度胺联合VAD方案治疗MM有效率高，且不良反应较低。     

PAD及VAD样-T方案治疗多发性骨髓瘤126例效果比较

目的：探讨多发性骨髓瘤（MM）行 PAD 方案（硼替佐米、多柔比星、地塞米松）及 VAD 方案（长春新碱、多柔比星／多柔比星衍生物、地塞米松）联合沙利度胺（VAD 样-T 方案）治疗效果的差异。方法回顾性分析54例接受 VAD 样-T 方案及72例接受 PAD 方案治疗的 MM 患者的疗效,包括完全缓解（CR）率、非常好的部分缓解（VGPR）率、总有效率（ORR）、总生存（OS）、无进展生存（PFS）及不良反应发生情况。结果 PAD 组 CR 率高于 VAD 样-T 组,差异有统计学意义[31.5%（23／72）比9.3%（5／54）,χ2＝0.30,P＝0.002],但是 VGPR 率及 ORR 两组相比差异无统计学意义[16.7%（12／72）比16.6%（9／54）,P＝0.180;82.2%（65／72）比81.5%（44／54）,P＝0.190]。 PAD 组中位 PFS 时间长于 VAD 样-T 组[（38.2±2.2）个月比（28.0±7.6）个月,P＝0.017];PAD 组3年 PFS 率和5年 OS 率高于 VAD 样-T 组,但差异均无统计学意义（均 P＞0.05）。 PAD 组末梢神经损害发生率高于 VAD 样-T 组,差异有统计学意义[31.5%（23／72）比14.5%（8／54）,P＝0.03]。结论虽然 VAD 样-T 方案的 CR 率低于 PAD 方案,中位PFS 时间短于 PAD 方案,但 VGPR 率、ORR、3年 PFS 率、5年 OS 率与 PAD 方案相当,且相对安全,末梢神经损害的发生率相对较低。对于国内无法使用硼替佐米及骨髓移植的初发 MM 患者,可选择 VAD 样-T作为一线诱导化疗方案。     

低剂量硼替佐米联合沙利度胺及化疗治疗多发性骨髓瘤35例

 目的　观察低剂量硼替佐米联合沙利度胺及化疗治疗多发性骨髓瘤（MM）患者的疗效及安全性。方法　35例初治及难治复发MM患者,硼替佐米1.1 mg／m2,第0、3、7、10天,静脉注射;沙利度胺从50 mg／d开始逐渐加量至150 mg／d或患者能够耐受的最大剂量;化疗方案根据每疗程患者情况选择MP、VAD或AD方案。28 d为1个疗程,每例患者至少接受2个疗程以上治疗。达到部分缓解（PR）及以上疗效的患者应用沙利度胺150 mg／d或患者能够耐受的最大剂量维持治疗。采用2006年MM国际统一疗效标准观察疗效,根据国际癌症研究中心不良事件通用命名标准评估不良反应。结果　中位随访20个月,35例患者治疗总有效率82.8 ％,其中完全缓解（CR）率48.6 %,良好的部分缓解（VGPR ）率17.1 %,PR率17.1 %。3年预计无进展生存（PFS）和总生存（OS）率分别为60.92 %和72.41 %。达PR以上疗效患者的OS率高于未达PR患者,差异有统计学意义（P＝0.004）。初治及难治复发患者客观缓解率（ORR）及OS率差异无统计学意义。Ⅲ～Ⅳ度非血液学毒性主要包括乏力（3／35）、恶心、呕吐（8／35）、便秘（4／35）和周围神经病变（3／35）。Ⅲ～Ⅳ度血液学毒性为粒细胞缺乏（10／35）和血小板减少（8／35）。结论　低剂量硼替佐米联合沙利度胺及化疗治疗MM具有较好的疗效及安全性,沙利度胺维持治疗可延长患者PFS时间。     

沙利度胺联合MP方案治疗多发性骨髓瘤的疗效评价

 目的　比较沙利度胺联合美法仑+泼尼松方案（MPT）与美法仑+泼尼松方案（MP）治疗多发性骨髓瘤（MM）的疗效与患者不良反应。方法　采用回顾性分析,MPT组26例,美法仑每天9 mg／m2口服,第1天至第4天,泼尼松60 mg／m2,第1天至第4天,或者美法仑每天4 mg／m2口服,第1天至第7天;泼尼松每天40 mg／m2口服,第1天至第7天,28 d为1个疗程,沙利度胺自化疗开始持续给药,100～200 mg／d,每4周为1个疗程,MP组21例,美法仑及泼尼松用法用量同MPT组,6个疗程后评价总疗效。结果　MPT组的总有效率（ORR）为65.4 %,明显高于MP组的42.9 %（P＞0.05）;MPT组中位反应时间为2个月,MP组为3个月;MPT组患者治疗后血红蛋白及清蛋白升高明显高于MP组（P＜0.05）;MPT组不良反应的发生率高于MP组（P＜0.05）,但两组3度以上的不良反应差异无统计学意义;MPT组中位无进展生存时间（PFS）为11个月,2年PFS为66.18 %。结论　与MP方案相比,MPT方案可以提高MM患者的有效率,改善生活质量,延长生存时间,耐受性良好。     

重组人血管内皮抑素治疗复发难治性多发性骨髓瘤的效果

目的 观察重组人血管内皮抑素(rhES)联合VD方案、常规方案(VCMP方案、VAD方案、MP方案)治疗复发难治性多发性骨髓瘤(RRMM)的临床疗效及安全性.方法 回顾性分析25例接受rhES联合VD方案、22例接受沙利度胺(Tha)联合VD方案、32例接受rhES联合常规方案、32例接受Tha联合常规方案治疗RRMM患者的临床资料,比较四组患者的总反应率(ORR)、无进展生存(PFS)、总生存(OS)及不良反应发生率.结果 rhES联合VD方案组、Tha联合VD方案组的ORR分别为76％(19/25)、59％(13/22),差异无统计学意义(x 2=1.540,P=0.215).rhES联合常规方案组、Tha联合常规方案组的ORR分别为44％(14/32)、34％(11/32),差异无统计学意义(x2=0.591,P=0.442).所有患者中21例死亡,3例失访,中位随访时间7.5个月(0.4～ 27.6个月).rhES联合VD方案组中位PFS和中位OS时间分别为6.9个月(0.5～ 17.3个月)、15.7个月(0.5～27.6个月),Tha联合VD方案组中位PFS和中位OS时间分别为5.2个月(0.5～14.6个月)、13.4个月(0.5～24.9个月),两组PFS差异有统计学意义(P=0.031),OS差异无统计学意义(P=0.129).rhES联合常规方案组中位PFS和中位OS时间分别为5.1个月(0.6 ～ 11.7个月)、6.3个月(0.6～ 18.6个月),Tha联合常规方案组中位PFS和中位OS时间分别为2.7个月(0.4～8.0个月)、3.4个月(0.4～15.7个月),两组PFS差异有统计学意义(P=0.017),OS差异无统计学意义(P=0.123).患者常见的不良反应为骨髓抑制所致的感染和便秘,但组间差异无统计学意义(P＞0.05).结论 rhES可作为RRMM治疗方案的有效补充,可延长PFS,改善患者的生命质量.     

沙利度胺联合美法仑及VAD方案治疗多发性骨髓瘤24例

 目的　评估沙利度胺联合美法仑及VAD方案治疗多发性骨髓瘤（MM）的疗效及不良反应。方法　治疗组共24例患者,均给予沙利度胺联合美法仑及VAD方案化疗,治疗2个疗程观察疗效。观察项目包括血清M蛋白、肝肾功能、尿蛋白、骨髓象、血象等,记录患者不良反应。疗效标准分为完全缓解（CR）、部分缓解（PR）、未缓解（NR）。结果　治疗组24例患者中CR 13例,PR 6例,NR 5例,有效率79.17 %。结论　沙利度胺联合美法仑及VAD方案治疗MM的临床疗效显著,症状改善明显。     

沙利度胺联合地塞米松治疗复发和(或)难治及平台期多发性骨髓瘤疗效分析

目的观察沙利度胺联合地塞米松（TD方案）治疗多发性骨髓瘤（MM）的疗效。方法62例MM患者,其中复发和（或）难治组25例,平台期组37例。复发和（或）难治组治疗方案为：TD方案3个疗程后无效或进展者更换方案;有效者,继续使用TD方案,3个疗程后停用地塞米松,单独使用沙利度胺直到复发。平台期组的患者仅使用3个疗程的TD方案,再单独使用沙利度胺维持治疗。结果25例复发和（或）难治的患者,前3个疗程TD方案的25例中20例总有效[非常好的部分缓解（VGPR）＋部分缓解（PR）＋进步（MR）]率为80％,但无完全缓解（CR）或接近完全缓解（nCR）。有效者,经后3个疗程TD治疗后,1例获得nCR,而2例PR患者回到MR,无患者发展到NR或进展;对13例VGPR＋PR＋nCR患者,单独使用沙利度胺4～12个月（中位时间6．8个月）后复发。37例平台期的患者经上述方案治疗8～26个月（中位时间17．5个月）后复发。明显优于难治和（或）复发组的治疗效果（P〈0．001）。结论沙利度胺联合地塞米松是难治和（或）复发MM有效治疗方案,也可作为平台期患者的维持治疗。     

Clinical Study of Thalidomide Combined with Dexamethasone for the Treatment of Elderly Patients with Newly Diagnosed Multiple Myeloma

Objective: To investigate the relationship between the efficacy and safety of different doses of thalidomide(Thal) plus dexamethasone (Dex) as the initial therapy in elderly patients with newly diagnosed multiplemyeloma (MM). Methods: Clinical data of 28 elderly patients with newly diagnosed MM who underwent theTD regimen as the initial therapy were analyzed retrospectively. The patients were divided into two groupsaccording to the maximal sustained dose of Thal: lower dose (group A) and higher dose (group B). The overallresponse rate (ORR), progression free survival (PFS), overall survival (OS), and adverse events (AES) werecompared between the two groups. Results: A total of 28 patients were followed up with a median of 18 months.The ORR was 60.1%. The median response time and PFS were 2.0 and 17.0 months, respectively. The meansustained dose of Thal in group B was significantly higher than group A (292.9 mg v 180.4 mg, P=0.01). Therewas no significantly difference in ORR (57.1% v 64.3%, P=1.00) and PFS (9.63months v 17.66 months, P=0.73)between groups A and B. During the follow up, only five patients died (<40%) and, therefore, median OS valueswere not available. It is estimated, however, that the mean survival time in the two groups was 35.6 and 33.4months (P>0.05), respectively. All of the patients tolerated the treatment well. The incidence of AES in patientswith a grading above 3 in group B was significantly higher than in group A (P=0.033). Conclusions: The TDregimen results in a high response rate and manageable AES as the initial therapy in elderly patients with MM.TD should be considered as the front line regimen for the treatment of elderly patients with MM in areas withfinancial constraints. The clinical response can be achieved at a low dose Thal with minimal toxicity.     

Pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone as first-line therapy for multiple myeloma

In patients with multiple myeloma (MM) who may ultimately receive active therapy, the combination of VAD (vincristine, doxorubicin, and dexamethasone) has been shown to be effective. However, the use of VAD is complicated by inherent risks that result from the use of central venous catheters, steroid toxicity, and by doxorubicin-associated adverse events such as cardiotoxicity and alopecia. To address these issues, a phase II trial investigating the combination of vincristine, pegylated liposomal doxorubicin, and reduced-schedule oral dexamethasone in the first-line treatment of patients with MM has been conducted. Patients with symptomatic, newly diagnosed MM were treated with intravenous (i.v.) pegylated liposomal doxorubicin 40 mg/m2 and vincristine 2 mg on day 1, along with dexamethasone 40 mg/day given either i.v. or orally for 4 days, every 4 weeks for a minimum of 6 cycles. Responses were reported in 29 patients (88%), and an additional 3 patients achieved stable disease. The median time to maximal response was 5.8 months (range, 0.7-13.6 months), and median overall survival time is estimated to be 60 months. This treatment regimen was well tolerated, and the most common grade 3/4 adverse events included hand-foot syndrome (21%), neutropenia (30%), anemia (21%), and mucositis (12%). Based on these results, the vincristine/liposomal doxorubicin/dexamethasone regimen appears to be effective and well tolerated in the first-line treatment of MM.     

大剂量地塞米松联合硼替佐米及沙利度胺治疗多发性骨髓瘤合并肾衰竭的临床研究

 【摘要】　目的　观察以大剂量地塞米松为基础的常规化疗加用硼替佐米及沙利度胺治疗后对多发性骨髓瘤合并急性肾衰竭患者的影响。方法　对23例伴肾衰竭的新发骨髓瘤患者均采用大剂量地塞米松加用硼替佐米和沙利度胺治疗,观察患者在用药前后肾损害的改善情况。结果　严重肾衰竭的12例患者中逆转1例,好转6例,总有效率58.3 %;肾衰竭的11例患者中逆转4例,好转5例,总有效率81.8 %。全部病例总有效率69.5 %（16／23）。对原发病骨髓瘤治疗总有效率60.9 %（14／23）。中位显效时间为2个月（1～5个月）。3年总体生存率为56.5 %,中位生存期34.4个月。结论　大剂量地塞米松联合硼替佐米和沙利度胺对新发骨髓瘤患者的肾衰竭逆转率高,对原发病治疗效果较好,不良反应少、安全可靠、见效快,可作为一线治疗用药。     

A Phase II trial of pegylated liposomal doxorubicin,vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma patients

BACKGROUND: Patients with multiple myeloma (MM) have increased bone marrow angiogenesis, a low plasma cell labeling index, and multidrug resistance (the primary cause of chemotherapy failure). MM patients receiving the vincristine, doxorubicin, and dexamethasone (VAD) regimen develop resistance and cardiac and steroid toxicity. Pegylated liposomal doxorubicin (Doxil/CAELYX) could potentially extend the duration of malignant plasma cell exposure to therapeutic levels of doxorubicin. This Phase II study evaluates combination pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone in MM patients. METHODS: Thirty-three newly diagnosed patients with MM received intravenous pegylated liposomal doxorubicin (40 mg/m(2)), vincristine (2.0 mg, Day 1), and oral or intravenous dexamethasone (40 mg per day for 4 days) every 4 weeks for six or more cycles and/or for two cycles after the best response. RESULTS: The overall response rate was 88%: 4 (12%) patients achieved a complete response, 18 (55%) a major response, and 7 (21%) a minor response. Three patients (9%) had stable and one (3%) had progressive disease. The median time to progression was 23.1 months, with 2-year and 3-year progression-free survival rates of 42% and 23%, respectively. The patient survival rate at 3 years was 67%. No patients discontinued treatment due to adverse events. Myelosuppression was manageable. The most common toxicities were Grade 3 palmar-plantar erythrodysesthesia, mucositis, and neutropenia. Only one patient experienced cardiotoxicity. CONCLUSIONS: Substituting pegylated liposomal doxorubicin for doxorubicin in the VAD regimen and reducing the dose of dexamethasone in patients with MM improve the safety profile and convenience of the treatment regimen without compromising efficacy.     

CTD方案与TD方案对初治多发性骨髓瘤的疗效对比

目的 分析应用环磷酰胺、沙利度胺和地塞米松(CTD)联合化疗方案与沙利度胺联合地塞米松(TD)方案治疗多发性骨髓瘤(MM)的效果差异,为骨髓瘤的治疗提供更加有效的治疗方法.方法 选取多发性骨髓瘤患者30例,随机分为2组,观察组的15例患者采用CTD方案进行治疗,对照组的15例患者采用TD方案进行治疗.接受6个疗程的治疗后分析观察组和对照组治疗有效率、不良反应发生情况及生存时间.结果 观察组15例患者中有13例得到不同程度的缓解,其中完全缓解(CR)4例,部分缓解(PR)6例,病情稳定(SD)1例,病情进展(PD)1例,严格的完全缓解(sCR)1例,总有效率(RR)为86.67％;对照组有9例患者得到不同程度的缓解,其中CR 1例,PR 4例,SD 3例,PD 1例,总有效率为60.00％ (8/15),与观察组比较差异具有统计学意义(P＜0.05).治疗后观察组血红蛋白增长值、血β2微球蛋白下降值及血浆中骨髓细胞比例下降值与对照组比较,差异具有统计学意义(P＜0.05).随访2 ～48个月,中位随访时间为24个月,观察组患者存活13例,生存率为86.67％,平均生存时间25个月;TD组患者存活8例,生存率为53.33％,平均生存时间为16个月,两组患者生存率及平均生存时间比较差异具有统计学意义(P＜0.05).观察组中常见不良反应如乏力、皮疹、头晕及白细胞减少等发生率较对照组明显降低,差异具有统计学意义(P＜0.05).结论 CTD联合化疗方案在多发性骨髓瘤的治疗中疗效比TD方案更加显著,患者的生存率得到了显著提高,CTD联合化疗方案优于TD方案.     

Limited benefits of thalidomide and dexamethasone maintenance after autologous stem cell transplantation in newly diagnosed multiple myeloma patients: a prospective phase II multi-center study in Korea

Although the clinical outcome of newly diagnosed multiple myeloma has improved with maintenance therapy, maintenance with novel agents is not always available depending on medical expenses or drug accessibility. We intended to investigate the efficacy and toxicity of thalidomide/dexamethasone maintenance in Korean patients. In this multicenter phase 2 study, patients with newly diagnosed myeloma who underwent induction chemotherapy followed by autologous stem cell transplantation (ASCT) were enrolled to receive maintenance treatment of 100mg thalidomide daily for 28 days and 40mg dexamethasone daily for 4 days each cycle. Maintenance was given up to 12 cycles. The primary endpoint was a 1-year event free survival (EFS) rate. It was assumed that EFS at 1-year would be 91% with thalidomide and 1-year EFS below 82% would be of no effect. A total of 43 patients were consecutively enrolled (median age, 58 years [range, 34 – 65]; male, n = 31). With a median follow-up duration of 17.3 months (range, 1.1 – 32.2), EFS at 1 year was 65.1% (95% confidence interval [CI], 48.9 – 77.3). PFS and OS at 1 year was 85.6% (95% CI, 70.7 – 93.3) and 90.4 (95% CI, 76.3 – 96.3), respectively. In terms of side effects, 39 patients (90.7%) experienced adverse events (AEs) of any grade, and 14 patients (32.6%) experienced grade 3 or 4 adverse events. 15 patients (34.9%) failed to complete 12 cycles of maintenance, and the most common reason for premature termination was AEs (n = 6). In Korean patients the benefits of thalidomide maintenance does not seem to outweigh the toxicity of thalidomide, especially in high-risk MM. Considering the long clinical course of MM, preservation of quality of life and finances might be more beneficial for subsequent MM treatment.     

Bortezomib and Dexamethasone Therapy for Newly Diagnosed Patients With Multiple Myeloma Complicated by Renal Impairment

BackgroundRenal impairment is a common complication of multiple myeloma (MM) and is related to shorter overall survival and increased rates of early death. Bortezomib is a new agent for the treatment of patients with myeloma, with high response rates and controllable side effects. In this study, we will evaluate the efficacy and safety of bortezomib and dexamethasone in patients with newly diagnosed MM complicated by renal impairment.Patients and MethodsThis is a prospective study of the general characteristics, reversibility of renal impairment, response of myeloma, and side effects of 18 consecutive newly diagnosed patients with MM and renal impairment who received ≥ 2 cycles of bortezomib and dexamethasone.ResultsOf 18 patients newly diagnosed with MM, the median age was 60 years, and the median serum creatinine was 5.3 mg/dL. Patients received a median of 4 cycles of bortezomib and dexamethasone. Reversal of renal impairment was documented in 38.9% of the patients, and the median time to reversal was 16 days. Moreover, 33.3% of the patients achieved renal response (a 50% decrease in serum creatinine). The overall response rate of MM was 83.3%, including a 33.3% complete response (CR) rate, a 16.7% near-CR rate, a 16.7% very good partial response (PR) rate, and a 16.7% PR rate. Grade 3/4 adverse events consisted of infection (n = 3), peripheral neuropathy (n = 3), and ileus (n = 1). After a median follow-up of 15.7 months, the median progression-free survival for all patients was 12.6 months.ConclusionBortezomib plus dexamethasone is a safe and effective regimen for newly diagnosed patients with MM complicated by renal impairment.     

Induction Treatment With Cyclophosphamide,Thalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma: A Phase II Study

Background:Thalidomide has alternative mechanisms of action; it can be combined with dexamethasone or alkylating agents for the treatment of multiple myeloma (MM); however, the optimal doses and appropriate intervals of thalidomide continue to be debated.Patients and Methods:We assessed the clinical efficacy and toxicity of thalidomide in patients with newly diagnosed MM; 68 patients were treated with pulsed cyclophosphamide, thalidomide, and dexamethasone (CTD) chemotherapy for induction treatment.Results:After a median of 28 months' follow-up, the overall response rate was 79.4%, with a 42.6% complete response (CR) or very good partial response (VGPR). Patients with cytogenetically high-risk disease had poor CR/VGPR rates (27.3%) at a median of 11.5 months of time to progression (TTP) compared with patients with standard-risk disease who achieved CR/VGPR rates (50%) at a median of 20.3 months of TTP. The major adverse events included peripheral sensory neuropathy (14.3%), infection (10.2%), and thromboembolic complications (5.9%). Thirty-two patients who achieved more than a PR proceeded to peripheral blood stem cell collection with a median number of 5.0 × 10⁶ CD34⁺ cells/kg collected.Conclusion:CTD resulted in a favorable response with tolerable toxicity in patients with MM and did not affect the yield of the stem cell collection.