硼替佐米及沙利度胺联合VAD方案治疗难治复发性多发性骨髓瘤疗效观察

目的:观察硼替佐米、沙利度胺联合VAD方案治疗难治复发性多发性骨髓瘤(MM)的临床疗效和不良反应。方法:9例难治复发性MM患者均采用硼替佐米、沙利度胺联合VAD方案治疗。其中,长春新碱0.4mg/d,d1～4;阿霉素10mg/d,d1～4;地塞米松40mg/次,d1～4,d9～12,d17～20;硼替佐米2mg/d,d1,4,8,11;沙利度胺,起始量100mg/d,根据患者情况,逐渐加量至200mg/d,每晚顿服,治疗2个周期。观察疗效,并按WHO不良反应分级标准判断不良反应。结果:9例患者,3例完全缓解/接近完全缓解(CR/nCR),4例部分缓解(PR),1例进步,1例无效,CR加PR率达77.8%,总有效率88.9%。不良反应主要有乏力、便秘、皮疹、胃肠道反应及末梢神经炎,均可耐受。结论:硼替佐米、沙利度胺联合VAD方案治疗难治复发性MM近期疗效显著,耐受性好,是一种新的治疗选择。     

硼替佐米联合VAD方案治疗多发性骨髓瘤

目的：观察硼替佐米联合VAD方案治疗初治、难治复发多发性骨髓瘤（MM）患者的疗效及安全性。方法：15例初治及难治复发MM患者,硼替佐米1.3mg/m2,d1、4、8、11或d0、3、7、10静脉注射,每28d1个疗程;每个疗程联合VAD方案化疗,每位患者接受2-6个疗程治疗。采用2006年MM国际统一疗效标准观察疗效,并按NCI/PNIH标准判断不良反应。结果：中位随访14个月,治疗总有效率80%,其中8例患者达完全缓解,1例患者达良好的部分缓解,3例患者达部分缓解,2例患者疾病无进展,1例患者治疗过程中疾病进展。最常见的不良反应包括胃肠道症状,不同程度的白细胞、血小板减少,周围神经病和乏力等,经对症治疗及调整用药剂量后均能改善。结论：硼替佐米联合VAD方案可提高MM患者治疗完全缓解率,并未增加周围神经毒性。     

硼替佐米为主化疗方案治疗初治与复发难治多发性骨髓瘤近期疗效分析

目的:分析硼替佐米为主化疗方案治疗初治与复发难治多发性骨髓瘤(MM)患者的临床疗效和不良反应.方法:初治MM患者11例,复发、难治MM患者7例均采用VD方案化疗:硼替佐米1.0～1.3 mg/m2第1、4、8和11天快速静脉注射,地塞米松20 mg第1～4天(7例复发难治予地塞米松40 mg)静脉滴注,3周为1疗程,所...     

硼替佐米联合地塞米松方案治疗多发性骨髓瘤的临床疗效

目的探讨硼替佐米联合地塞米松方案治疗多发性骨髓瘤(MM)的临床疗效。方法选取该院诊治的51例MM患者作为研究对象,按治疗方案分为两组,观察组31例采用硼替佐米联合地塞米松治疗,对照组20例接受长春新碱、吡柔比星、地塞米松和左旋苯丙氨酸氮芥(马法兰)治疗。比较两组患者临床疗效、不良反应等情况。结果观察组总有效率为80.65%(25/31),对照组总有效率65.00%(13/20)差异显著(P<0.05);观察组对初治病例有效率为86.36%(19/22),难治复发病例有效率为66.67%(6/9);对肾功能正常病例有效率为90.00%(18/20),对肾功能损害病例的有效率为63.64%(7/11)差异显著(P<0.05);观察组总不良反应发生率为51.61%,对照组为65.00%,差异显著(P<0.05)。结论硼替佐米联合地塞米松治疗MM有效率高,不良反应轻,对初治患者疗效最显著,值得推广应用。     

硼替佐米为主治疗多发性骨髓瘤的疗效与安全性临床观察

目的:研究以硼替佐米为主的联合化疗对多发性骨髓瘤(MM)的疗效及其不良反应。方法:回顾性分析52例MM患者,其中42例接受以硼替佐米为主的联合化疗方案:初发MM 31例,复发难治MM 11例;轻链型12例,非轻链型30例;肾功能正常27例,肾功能损害15例;另外10例接受传统型(含长春新碱+蒽环类+地塞米松)化疗方案。比较硼替佐米初治组与传统化疗组,硼替佐米治疗组中轻链型与非轻链型、肾功功能正常者与肾功能损害者的疗效。同时观察42例硼替佐米治疗患者的不良反应。结果:硼替佐米初治组总有效率(ORR)和完全缓解(CR)+非常好的部分缓解(VGPR)率分别为87.10%(27/31)和64.52%(20/31),分别优于传统化疗组的20.00%(2/10)和10.00%(1/10),2组比较均差异有统计学意义(均P0.05)。硼替佐米治疗组中非轻链型患者的ORR和CR+VGPR率分别为76.67%(23/30)和56.67%(17/30),分别高于轻链型患者的75.00%(9/12)和50.00%(6/12),但2组比较差异无统计学意义;肾功能正常患者的ORR和CR+VGPR率分别为77.78%(21/27)和59.26%(16/27),分别高于肾功能损害者的73.33(11/15)和46.67%(7/15),但2组比较差异亦无统计学意义。接受硼替佐米治疗的42例患者中,不良反应主要为乏力(28.57%、12/42)和周围神经炎(35.71%、15/42)。在给药途径方面,硼替佐米静脉给药组乏力和周围神经炎的发生率,均分别高于硼替佐米皮下注射组(42.86%∶14.28%,52.38%∶19.05%,均P0.05)。结论:以硼替佐米为主的方案治疗初发MM疗效优于传统化疗方案,肾功能不全患者可以安全使用。硼替佐米的主要不良反应为乏力和周围神经炎,不良反应可以耐受。硼替佐米皮下注射给药可以有效减少不良反应,安全性相对较高。     

不同化疗方案治疗多发性骨髓瘤的临床疗效观察

目的:观察并评价分别接受不同化疗方案[长春新碱+多柔比星+地塞米松(VAD)、马法兰+泼尼松+沙利度胺(MPT)和硼替佐米+地塞米松(VD)]对初治多发性骨髓瘤(MM)患者的疗效。方法:对确诊为MM的76例患者进行回顾性分析,其中28例采用VD方案,39例采用VAD方案,9例采用MPT方案,判定以上3种方案的疗效。结果:VD方案的疗效优于VAD和MPT方案(89.3%∶61.5%,P<0.05;89.3%∶33.3%,P<0.01),不良反应发生率低于VAD和MPT方案(35.7%∶66.7%,P<0.05;35.7%∶100%,P<0.01)。结论:VD方案治疗MM的疗效明显优于VAD和MPT方案,且不良反应较少,是一种值得推荐治疗MM的安全、可靠及有效的方法。     

硼替佐米联合化疗治疗10例多发性骨髓瘤

目的:观察硼替佐米联合化疗药物治疗初治、复发难治多发性骨髓瘤(MM)的疗效及安全性。方法:5例初治MM患者在每一疗程的第1、4、8、11天静脉注射硼替佐米0.7～1.3mg/m2,每3周为一疗程;每2个疗程(6周)的第1～4天,口服美法仑9mg/(m2·d)和泼尼松60mg/(m2·d);每例患者至少接受2～10个疗程。5例复发难治患者,在每3周1个疗程,第1、8天分别静脉注射硼替佐米3.5mg,或第1、4、8、11天1.0～1.3mg/m2。每次用硼替佐米前静脉注射地塞米松40mg;每例患者至少接受1～6个疗程。采用Blade标准评价疗效,按照美国国立癌症研究所(NCI)(第3版)判断不良反应。结果:中位随访8个月,5例初治患者中2例完全缓解(CR),1例接近完全缓解(nCR),1例部分缓解(PR),1例轻微反应(MR)。5例复发难治患者中,2例nCR,2例MR,1例无改变(NC)。主要不良反应包括胃肠道症状、不同程度的血小板减少、周围神经症状和乏力等。经对症治疗及调整用药剂量后均能改善。结论:硼替佐米对于初治或复发难治的MM患者,是一种可以耐受的、疗效确切的新的治疗选择。     

多发性骨髓瘤细胞遗传学变化及其蛋白酶体抑制剂的疗效观察

目的分析多发性骨髓瘤(MM)的细胞遗传学变化及其与蛋白酶体抑制剂治疗的关系。方法对2005年1月至2006年7月北京大学人民医院29例初诊的MM患者行染色体核型检查,采用骨髓细胞24h短期培养,用常规方法制备染色体,G显带进行核型分析。22例MM患者采用传统化疗即长春新碱联合阿霉素和地塞米松(VAD)方案或马法兰与泼尼松(MP)方案;7例患者应用蛋白酶体抑制剂(硼替佐米)为主的化疗方案。比较两组患者的有效率及缓解率。结果29例MM患者中异常核型检出率为37.9%,其中有复杂和高度复杂畸变的占81.8%。采用VAD或MP方案化疗的核型正常组的有效率为81.2%,核型异常组有效率为0,差异有显著性意义(P<0.05)。应用硼替佐米为主的化疗方案中核型异常组5例均有效,核型正常组2例均有效。核型异常组硼替佐米有效率与传统化疗组相比,差异有显著性意义(P<0.05)。结论染色体核型异常的患者,应首选蛋白酶体抑制剂硼替佐米等进行治疗。     

硼替佐米的累计剂量对多发性骨髓瘤患者生存的影响

目的:探讨硼替佐米的累计剂量对多发性骨髓瘤(MM)患者生存期的影响。方法:回顾172例MM患者的临床特点、实验室检查及治疗方法。以硼替佐米的中位累计剂量21mg/m~2为临界值,将172例MM患者根据中位累计剂量分为A组(21mg/m~2,86例)和B组(≥21mg/m~2,86例),对2组患者的基本资料采用t检验(连续变量)和χ~2检验(分类变量)进行校检,并对2组采用Kaplan-Meier生存曲线进行生存分析,Log-rank检验作单因素分析。172例MM患者中,使用含硼替佐米化疗方案的患者有83例,以硼替佐米的累计剂量21mg/m~2为临界值,将患者分为C组(21mg/m~2)和D组(≥21mg/m~2);使用含硼替佐米化疗方案联合其他化疗方案的患者有89例,以硼替佐米的累计剂量21mg/m~2为临界值,将患者分为E组(21mg/m~2)和F组(≥21mg/m~2),对C、D两组以及E、F两组采用Kaplan-Meier生存曲线进行生存分析,Log-rank检验作单因素分析。结果:172例MM患者中,B组患者的中位生存期明显高于A组(73.53个月∶18.90个月,P0.01);83例使用包含硼替佐米化疗方案的患者中,D组患者的中位生存期明显高于C组(60+个月∶17.67个月,P0.01);89例使用包含硼替佐米化疗方案联合其他治疗的患者中,F组患者的中位生存期明显高于E组(57.13个月∶26.67个月,P0.01)。与硼替佐米累计剂量低的患者相比,硼替佐米累计剂量较高的患者的严重不良反应发生率未增加。结论:提高硼替佐米的累计剂量能延长MM患者的生存期,而且未增加严重不良反应的发生率。     

不同剂量硼替佐米治疗多发性骨髓瘤的临床研究

目的:观察1.6mg/m2和1.3mg/m2两种剂量硼替佐米联合沙利度胺、地塞米松治疗多发性骨髓瘤患者的疗效和毒副反应。方法:快速静脉给予1.6mg/m2或1.3mg/m2 2种不同剂量的硼替佐米,同期应用沙利度胺和地塞米松。采用2006年国际骨髓瘤工作组制定的标准判定疗效,并按NCI CTCAE标准判断不良反应。结果:①剂量为1.6mg/m2的9例患者中,3例达到完全缓解(CR),CR率为33%;1.3mg/m2组25例患者中,8例达到CR,CR率为32%,2组差异无统计学意义(P>0.05);②2个疗程后早期评价疗效,1.6mg/m2组的总有效率(ORR)为87.5%,1.3mg/m2组ORR为43.5%,两组差异具有统计学意义(P<0.05);③2组主要不良反应多为胃肠道症状、周围神经病变、血小板减少,1.6mg/m2组发生率依次为66.7%、55%和33%,1.3mg/m2组发生率依次64%、56%和28%,两组差异无统计学意义(P>0.05)。结论:硼替佐米联合沙利度胺、地塞米松治疗多发性骨髓瘤临床疗效明显,不良反应轻微,1.6mg/m2硼替佐米组患者的症状改善明显,且起效快于1.3mg/m2组,患...     

Intermediate doses of melphalan and dexamethasone are better than vincristine,adriamycin, and dexamethasone (VAD) and polychemotherapy for the treatment of primary plasma cell leukemia

Primary plasma cell leukemia (PPCL) is a rare form of disease accounting for 1-2 percent of myelomas. Between September 1990 and November 2000, among 540 patients with myeloma studied, 24 fulfilled the criteria of PPCL (4.4 percent). We found high frequencies of female patients (62 percent), Bence Jones proteinuria (79 percent), anemia (88 percent), bleeding (54 percent), confusional syndrome (42 percent), weight loss (71 percent), hepatomegaly (25 percent), splenomegaly (21 percent), leukocytosis (62 percent), and thrombocytopenia (71 percent). High serum levels of creatinine, calcium, lactate dehydrogenase (LDH), and beta(2)-microglobulin were detected in 50 percent, 37 percent, 58 percent, and 71 percent, respectively. Four patients were treated with vincristine, melphalan, cyclophosphamide, prednisone, and adriamycin (VMCPA), 12 with vincristine, adriamycin, and dexamethasone (VAD), and 8 with M-80 (oral melphalan 80 mg/m(2) plus dexamethasone 40 mg/m(2)). There was a trend toward lower values of Karnofsky score (P=0.07) and higher values of LDH (P=0.2) in the VAD group. Other clinical characteristics were comparable among the three groups. Complete plus partial responses were achieved in one and six patients treated with VMCPA and M-80, respectively. All patients treated with VAD failed to respond to treatment. Patients receiving the M-80 regimen experienced higher platelet toxicity (P=0.05), vomiting (P<0.0003), and mucositis. Also, the need for red blood cell transfusions was higher in the M-80 group. Median overall survival was 60 days. Overall survival was better in patients achieving complete or partial response. In conclusion, our study illustrates that intermediate doses of melphalan plus dexamethasone are an effective chemotherapy regimen for this aggressive disease. Response to treatment is the only prognostic factor for survival in these patients.     

Modified adriamycin-vincristine-dexamethasone (m-VAD) in primary refractory and relapsed plasma cell myeloma: an NCI (Canada) pilot study

The purpose of this single arm phase II study was to test a modified version of the three drug combination vincristine, adriamycin and dexamethasone (m-VAD), in which intravenous vincristine (0.4 mg/d) and adriamycin (9 mg/m2 per day) infusions are administered for only 2 h on days 1-4 of each 28 d cycle, in patients with refractory multiple myeloma. In addition, only two 4 d courses of dexamethasone 40 mg/d was given during each cycle. The entry criteria for 44 patients included plasma cell myeloma and a measurable monoclonal peak, either refractory to initial treatment with melphalan and prednisone, or resistant to melphalan and prednisone after initially responding (resistant relapsed disease, 27 patients). Patients treated previously with chemotherapy other than melphalan and prednisone were excluded. There were no complete responses. Of the 41 evaluable patients who completed at least one course of therapy 11 had a partial response (27%, 95% C.I. 14-40%). The response rates were 19% for primary refractory disease patients, and 32% for those with resistant relapsed disease. The median duration of response was 4 months. The median survival for all 44 patients was 7.6 months (5.5 months for primary refractory patients, and 10 months for relapsed resistant disease patients). Episodes of documented bacterial infection occurred in 12 patients, and 10 patients had minor viral infection. The dexamethasone dose was reduced in 12 patients. The median neutrophil nadir was 1.2 x 10(9)/l, and median platelet nadir was 147 x 10(9)/l. Five deaths were judged as treatment related and occurred during marrow cytopenia. The results of this modified form of VAD are inferior to that reported previously for 4 d continuous infusions of vincristine and doxorubicin. This could be related to either patient selection factors, or to a reduction of the efficacy of the drug combination produced by either the shortened intravenous infusions and/or omission of one 4 d course of dexamethasone.     

Administration of a modified chemotherapeutic regimen containing vincristine, liposomal doxorubicin and dexamethasone to multiple myeloma patients: preliminary data

For elderly patients with multiple myeloma (MM), conventional melphalan and prednisone (MP) therapy has been the treatment of choice; the vincristine, doxorubicin and dexamethasone (VAD) regimen is preferred for younger patients who also receive high-dose melphalan in combination with autologous or allogeneic bone marrow transplantation (BMT). Although survival time is similar in both the MP and VAD regimens, the continuous infusion of doxorubicin which the latter treatment entails constitutes a disadvantage along with the 4-day hospitalization required. Doxorubicin also induces cardiotoxicity, particularly in the elderly. A modified form of VAD therapy includes liposomal doxorubicin (Caelyx) (40 mg/m2 for 1 d) [corrected], oncovin (2 mg for 1 d) and dexamethasone 40 mg for 4 d per os. Doxorubicin encapsulated with liposomes has less cardiotoxicity, is more efficient and has fewer side effects than conventional doxorubicin, and it can be administered on an outpatient basis: dexamethasone can be given orally and vincristine in bolus infusion. In order to estimate its efficacy and tolerability, we administered this regimen to 12 patients (first-line treatment in 6 patients, salvage therapy in 6 patients). All patients exhibited good tolerance to liposomal doxorubicin with no severe side effects. Eight patients achieved complete hematological remission and three partial response. One patient died before completing the treatment. In conclusion, compared to other therapies, this modified VAD regimen containing liposomal doxorubicin can be more easily administered to MM patients, without severe side effects and with increased full remission rates, almost similar to those with the conventional VAD treatment.     

Potential value of vintristine-adriamycin-dexamethasone combination chemotherapy (VAD) in refractory and rapidly progressive myeloma

10 patients with myeloma refractory to alkylating agents were treated with either 4-d pulses of high-dose dexamethasone therapy, or 4-d pulsed high-dose dexamethasone in combination with 4-d continuous infusions of vincristine and adriamycin (VAD). 8 patients were evaluated after a median duration of treatment of 2.3 courses (range 1 to 4). 6 of the 8 evaluable patients achieved reduction in serum and/or urine paraprotein levels with a mean reduction in serum paraprotein of 74.1%. There was a concomitant improvement in wellbeing in these responding patients. 2 evaluable patients failed to show biochemical or clinical response (1 treated with VAD, 1 high-dose dexamethasone). 2 patients currently survive 390 d and 180 d, respectively, on continuing therapy. 8 patients died with a mean duration of survival of 99 d (range 10 to 246 d). We conclude that the use of VAD chemotherapy in patients with refractory myeloma confers both a worthwhile remission of disease symptoms and biochemical evidence of disease regression, and that trials of VAD as primary treatment for myeloma are indicated.     

VAD chemotherapy of multiple myeloma

Twelve patients with resistant or recurrent multiple myeloma were treated with VAD regimen (vincristine, adriamycin, dexamethasone), first reported by Barlogie B et al 1984. Of 11 evaluable patients, 7 responded (partial response [PR] 3, minor response [MR] 4), and the overall response rate was 63.7%. The median interval to achieve remission was 27 days, and the median duration of remission was 125 days. One course seemed sufficient for the assessment of effectiveness of the VAD chemotherapy, because in all responders, over 50% reduction of monoclonal protein was obtained in the first course of chemotherapy. We also administered verapamil or trifluoperazine in addition to VAD in two patients who had acquired resistance to VAD. Both had MR. Side effects included infections, gastro-intestinal bleeding, congestive heart failure or severe malaise. In conclusion, the VAD chemotherapy is effective but the duration of remission is short and side effects cannot be disregarded. Perspective of VAD and improvement of the management of refractory multiple myeloma is discussed.     

Treatment of refractory multiple myeloma with the vincristine-adriamycin-dexamethasone (VAD) regimen

Summary Seventeen patients with advanced refractory multiple myeloma were treated with a 4-day continuous infusion of vincristine and adriamycin in combination with 4-day intermittent high-dose dexamethasone (VAD). Ten patients entered a partial remission (59%). Complete remission was not achieved in any patients. The median response duration was 11 months and the median survival of the responding patients was 18 months versus 5 months for non-responders. Major complications during VAD treatment were infections probably due to a combination of myelosuppression and intensive corticosteroid therapy. The VAD regimen offers a useful chemotherapy that produces an overall high response rate even in intensively pretreated patients resistant to first line therapy. The treatment results in a clear tendency to longer survival in responding patients.     

Treatment of plasma cell leukemia with vincristine, liposomal doxorubicin and dexamethasone

Primary plasma cell (PCL) leukemia is a rare lymphoproliferative disorder characterized by a malignant proliferation of plasma cells in the bone marrow and peripheral blood. Survival with standard therapy using melphalan is very poor. Doxorubicin encapsulated with liposomes has less cardiotoxicity, is at least as efficient and has fewer side effects than conventional doxorubicin. Two female patients (69 and 54 yr old) with primary PCL are described in this study. They both received a modified form of VAD (vincristine, doxorubicin and dexamethasone), a regimen which includes liposomal doxorubicin (40 mg/m2 for 1 d), vincristine (2 mg for 1 d) and dexamethasone 40 mg per os on days 1-4, 9-12 and 17-20. A disease evaluation of the first patient after six courses of the modified \VAD regimen showed no plasma cells in the peripheral blood, a decrease in the serum M protein level and a plasma cell infiltration in the bone marrow of less than 5%. The patient died from a cardiac episode 24 months post-diagnosis, while she was in complete hematological remission. The second patient also exhibited good tolerance to liposomal doxorubicin with no side effects, achieved complete haematological remission and remains in good condition 7 months after the last VAD administration. These results suggest that this modified form of VAD regimen also seems to work in PCL and is well tolerated with no side effects.     

Bolus therapy with mitoxantrone and vincristine in combination with high-dose prednisone (NOP-bolus) in resistant multiple myeloma. Nordic Myeloma Study Group (NMSG).

In a phase II study, 58 patients with resistant multiple myeloma (MM) were treated with a combination chemotherapy (NOP-bolus regimen) consisting of mitoxantrone (16 mg/m2 for the first 25 patients and 12 mg/m2 for the subsequent 33), vincristine (2 mg), both as bolus injections on day 1 and prednisone (250 mg/d on d 1-4 and 17-20). In patients greater than 70 years of age, the mitoxantrone dose was reduced to 12 mg/m2 or 8 mg/m2, respectively. The treatment was repeated every 4 weeks. A response (greater than 50% reduction in M component) was obtained in 26% of the patients and a minor response (clinical improvement but less than 50% reduction in M component) in another 21%. Median response duration was 27 wk and median survival for all patients was 25 wk. There were no differences in response rate or duration between patients receiving the high or low mitoxantrone dose, but patients in the low-dose group had fewer serious infections.     

High-dose glucocorticoid treatment of resistant myeloma

Intermittent, high-dose dexamethasone treatment was given to 49 consecutive patients with refractory multiple myeloma. In patients who were unresponsive to previous treatment, the response rate of 27% was similar to that achieved with the VAD regimen, which combines the same schedule of dexamethasone with vincristine and doxorubicin given by continuous infusion. Among patients with relapses, VAD chemotherapy induced remissions in 11 of 17 patients (65%), whereas dexamethasone alone induced remissions in 4 of 19 (21%). The median survival of all patients responding to either treatment, 22 months, was longer than that from any previous program for treatment of resistant myeloma. These findings indicate the value of frequent dexamethasone administration in patients unresponsive to standard therapy and show the major role of vincristine and doxorubicin given by continuous infusion in patients with relapses. They also suggest different mechanisms for primary and secondary resistance to chemotherapy.     

Thalidomide-dexamethasone plus pegylated liposomal doxorubicin vs. thalidomide-dexamethasone: a case-matched study in advanced multiple myeloma

OBJECTIVES: Nearly all patients with multiple myeloma (MM) relapse or become refractory to front-line therapy. Several salvage therapies have been explored, but the optimal combination regimen has not been defined. We performed a case-matched study comparing patients with relapsed/refractory MM receiving thalidomide-dexamethasone alone or the combination thalidomide-dexamethasone-liposomal pegylated doxorubicin. METHODS: Forty-seven patients received thalidomide (100 mg/d), dexamethasone (40 mg p.o. on days 1-4 and 9-12), and pegylated liposomal doxorubicin (40 mg/m(2) on day 1 every 28 d) (ThaDD). Their clinical outcome was compared with that of 47 pair mates selected from patients treated at relapse with thalidomide (100 mg/d) and dexamethasone (40 mg p.o. on days 1-4) (Thal-Dex) and matched for age, beta2-microglobulin and previous therapy. RESULTS AND CONCLUSIONS: Overall response rate was significantly higher in ThaDD group (92% vs. 63.5%; P < 0.0001) as partial response rate (> or =PR) (75.5% vs. 59.5%; P = 0.077), very good partial response rate (> or =VGPR) (36% vs. 15%; P = 0.018) and near complete remission rate (> or =nCR) (30% vs. 10.5%; P = 0.002). Non-hematologic toxicity was similar in the two groups of patients whereas hematologic toxicity and infections were significantly higher in ThaDD patients. Median progression-free survival, event-free survival, and overall survival were significantly longer in patients receiving ThaDD than in those treated with Thal-Dex. ThaDD regimen significantly improved response rate and overall survival in comparison with Thal-Dex. Although the frequency of hematologic toxicity and infections resulted higher in ThaDD group compared with control group, they were not particularly frequent after adequate prophylaxis was added and were easily managed when occurred.