Objcetive To assess the efficacy and safety of lenalidomide plus dexamethasone (LD) compared with placebo plus dexamethasone (PD) for relapsed or refractory multiple myeloma. Methods Data were searched in The Cochrane Library (Issue 3, 2010), MEDLINE (with PubMed, 1966 to Nov. 2010), EMbase (1984 to Nov. 2010), CBMdisc (1978 to Nov. 2010), and CNKI (1979 to Nov. 2010), and also searched in clinical trials register for ongoing studies and completed studies with unpublished data. The references of the included studies and relevant supplement or conference abstracts were handsearched. Randomized controlled trials were included. The data were extracted, and then the quality of the included studies was assessed by two reviewers independently. RevMan 5.0 software was used for meta-analyses for studies with low heterogeneity. Results Two studies involving 704 participants were included. One was high quality study, while the other was unclear about randomization and allocation concealment. The adverse outcomes of LD, such as mortality (RR=0.78, 95%CI 0.62 to 0.97, P=0.03) and incidence of disease progression (RR=0.16, 95%CI 0.08 to 0.34, Plt;0.000 01), were better than those of PD, which had significant differences. The overall response rate was higher in the LD group than in the PD group (RR=2.75, 95%CI 2.22 to 3.41, Plt;0.000 01). The incidence of thrombotic event (RR=3.20, 95%CI 1.78 to 5.73, Plt;0.000 1), the Grade Three and Grade Four neutropenia (RR=10.20, 95%CI 5.76 to 18.08, Plt;0.000 01), the Grade Three and Grade Four thrombocytopenia (RR=2.08, 95%CI 1.28 to 3.38, P=0.003), and the incidence of drug withdrawal or dosage reduction due to adverse reactions (RR=1.34, 95%CI 1.21 to 1.49, Plt;0.000 01) were all higher in the LD group than in the PD group. Conclusion The efficacy of LD is superior to that of PD for relapsed or refractory multiple myeloma, but the incidence of drug adverse events, such as thrombosis, Grade Three or Grader Four neutropenia or thrombocytopenia, is also higher than that of PD, which has to be prevented positively.
Objective To evaluate the efficacy of bisphosphonates in treating patients with Multiple Myeloma. Methods The databases including The Cochrane Library, PubMed, EMBASE, CBM, and CNKI were searched. Quality assessment and data extraction were conducted by two reviewers independently, and disagreement, if any, was resolved by discussion. Meta-analyses were performed for homogeneous studies. Results Eleven RCTs were included, all of which came from abroad. The methodological quality of the included studies was good. The baseline data of each trial were comparable. Meta-analyses showed that, the pooled analysis of the published evidence demonstrated the beneficial effect of bisphosphonates on prevention of pathological vertebral fractures (OR=0.59, 95%CI 0.45 to 0.78, P=0.000 1) and on relieving pain (OR=0.59, 95%CI 0.46 to 0.76, P=0.000 05). However, the analysis of the effect of bisphosphonates on pain was based on clinically heterogeneous data which must be interpreted with caution. Meanwhile, there was no significant effect of bisphosphonates on mortality (OR=0.99, 95%CI 0.88 to 1.12, P=0.9) and hypercalcemia (OR=0.76, 95%CI 0.56 to 1.03, P=0.07). Conclusions Adding bisphosphonates to the treatment of myeloma can reduce pathological vertebral fractures and pain, but is not helpful to mortality and hypercalcemia.
Objective To evaluate the effectiveness of PTD regimen (pamidronate disodium + thalidomide + dexamethasone) and TD regimen (thalidomide + dexamethasone) in the treatment of multiple myeloma. Methods The patients meeting the inclusion criteria were randomly treated with PTD and TD regimens from January 2004 to December 2008. The effectiveness and safety of the two groups were observed after 8 weeks and the statistical analyses were performed using SPSS 13.0 software. Results A total of 25 patients were included, of which 13 were treated with PTD regimen and the other 12 were treated with TD regimen. The results showed overall response rates were 84.6% and 83.3% in the PTD and TD groups, respectively, with no significant difference (Pgt;0.05). The complete response rate (5/13 vs. 1/12) and early response rate (within 2 weeks, 4/13 vs. 1/12) for bone pain in the PTD group were better than those of TD group (Plt;0.05). Conclusion Compared with TD regimen, PTD regimen has more dramatic and faster effects on bone pain relief for multiple myeloma, but for overall response rate, further larger sample size randomized controlled trials are needed.
Objective To assess the effectiveness and safety of thalidomide for treating multiple myeloma in China. Methods Randomized controlled trials (RCTs) of thalidomide for multiple myeloma were collected from CNKI (1979 to 2008), CBMdisc (1979 to 2008), and VIP (1989 to 2008) databases. Other relevant journals were also handsearched. The methodological quality of the included studies was evaluated, and data analyses were performed using the Cochrane Collaboration’s software RevMan 4.3. Results A total of 9 RCTs involving 324 patients were included. As for the total effective rate and complete remission rate, significant differences were found between thalidomide + MP vs. MP alone (RR=1.34, 95%CI 1.05 to 1.70; RR=1.77, 95%CI 1.26 to 2.49) and thalidomide + VAD vs. VAD alone (RR=1.45, 95%CI 1.20 to 1.75; RR=1.73, 95%CI 1.25 to 2.39). Conclusion According to the domestic evidence, treatment for multiple myeloma with thalidomide can improve the total effective rate and the complete remission rate. However, more high–quality, large-sample, randomized, double-blind, controlled trials are required.
ObjectiveTo investigate the efficacy and safety of bortezomib combined with dexamethasone and thalidomide regimens on aged patients with multiple myeloma. MethodsA total of 166 multiple myeloma patients were selected between January 2009 and June 2013; all patients were assigned to regimens of T-VD or T-VAD named T-VD group or T-VAD group (with 25 patients in T-VD group and 29 in T-VAD group). Efficacies and toxicities were analyzed and compared after two cycles. ResultsOverall response rate (OR) in T-VD group was 84.0%; there was 6 patients achieved complete response (OR) or very good partial response (VGPR) (24.0%). However, Overall response rate (OR) in T-VAD group was 48.3%; there was only one patient achieved CR or VGPR (3.4%); significant difference between two groups was found (χ2=7.513, P<0.05). The major adverse reactions were debilitation, nausea, vomiting, myelo-suppression, cardiac toxicity, and peripheral neuropathy. There were highest incidence of nausea and vomiting in T-VAD group compared to T-VD group (χ2=5.794, P<0.05). ConclusionBortezomib combined with dexamethasone and thalidomide regimens is effective and safe, which can be widely used for aged patients with multiple myeloma.
ObjectiveTo systematically review the efficacy and safety of non-myeloablative stem cell transplantation (NST) for the treatment of multiple myeloma (MM) after first autologous stem cell transplantation. MethodsSuch databases as The Cochrane Library (Issue 5, 2013), PubMed, EMbase, CBM, CNKI, VIP and WanFang Data were electronically searched to collect studies investigated the efficacy and safety of NST and non-NST for the treatment of MM after first autologous stem cell transplantation from the date of their establishment to June 13th 2013. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data and evaluated the methodological quality of the included studies. Then meta-analysis was performed using RevMan 5.1 software. ResultsSeven studies involving 1 961 participants were included, of which 626 cases were in the NST group and 1 335 cases were in the non-NST group. The results of meta-analysis showed that no significant difference was found between both groups in the overall survival rate (HR=1.06, 95%CI 0.78 to 1.44, P=0.69) and progress-free survival rate (HR=0.92, 95%CI 0.76 to 1.11, P=0.39). However, there were significant differences in the complete remission rate (RR=1.29, 95%CI 1.13 to 1.48, P=0.000 2) and treatment-related mortality rate (RR=3.40, 95%CI 2.27 to 5.07, P < 0.000 01). ConclusionThe efficacy of NST is not superior to non-NST for patients with MM which has received first autologous stem cell transplantation. It is not sufficient to recommend NST as the first-line treatment of MM based on the currently available evidence.
ObjectiveTo systematically review the effect of thalidomide as first-line therapy on postrelapse survival rate of patients with multiple myeloma (MM). MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 1, 2007) and Web of Science were searched to collect randomized controlled trials (RCTs) about thalidomide as first-line therapy for MM from 2006 to 2011. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.1 software. ResultsA total of 16 RCTs involving 6097 patients were included. The results of meta-analysis showed that, compared with the chemotherapy alone group, early application of thalidomide could significantly decrease the postrelapse survival rate (HR=1.23, 95%CI 1.05 to 1.45, P=0.002). Subgroup analysis showed that, compared with the chemotherapy alone group, thalidomide maintenance therapy after autologous stem cell transplantation (ASCT) couldn’t decrease the postrelapse survival rate (HR=0.90, 95%CI 0.57 to 1.41, P=0.64), but thalidomide induction therapy before ASCT (HR=1.21, 95%CI 1.01 to 1.45, P=0.04) and thalidomide induction therapy before ASCT combined maintenance therapy after ASCT (HR=1.41, 95%CI 1.13 to1.76, P=0.002) could significantly decrease the postrelapse survival rate. ConclusionCurrent evidence shows that, thalidomide maintenance therapy after ASCT for MM is a better therapy regimen. It couldn’t decrease the survival rate after recurrence, but could increase the disease-free survival (DFS) and overall survival (OS) of patients with MM. Due to the limited quality of included studies, the above conclusion still needs to be verified by more high quality studies.
Objective To investigate the value of a 4-color and 10-antibody flow cytometry immunophenotyping panel using 10 antibodies including CD45, CD38, CD19, CD56, CD20, CD5, CD10, human leukocyte antigen-DR (HLA-DR), κ antibody and λ antibody marked by four kinds of fluorescein including R-phycoerythrin (PE), fluorescein isothiocyanate (FITC), peridinin chlorophy Ⅱ protein (PerCP) and allophycocyanin (APC) in the diagnosis of multiple myeloma (MM). Methods A 4-color and 10-antibody flow cytometry immunophenotyping panel which used CD45dim/-/CD38high as gating strategy supplemented by CD19, CD56, CD20, CD10, CD5, HLA-DR, κ antibody and λ antibody was used to test the bone marrow (BM) specimens of 45 MM patients treated between December 2013 and March 2015. Then by morphological examination, we analyzed the quantitative results and characteristics of myeloma cells. Results In all the 45 MM patients, the myeloma cell detection rate was 100% by flow cytometry. The proportion range of myeloma cells in BM was between 1.17% and 72.31%, which showed a good consistency with the results of 7.5%-90.0% detected by morphological examination. The positive expression rates of antigen on myeloma cells were: 100.00% for CD38, 11.11% for CD45, 2.22% for CD19, 73.33% for CD56, 17.78% for CD20, 42.22% for HLA-DR, and 0% for CD10 and CD5. About 64.44% of the MM patients were restricted cytoplasmic λ light chain typing, and 35.56% were restricted cytoplasmic κ light chain typing. There was no obvious phenotype difference among the 3 Durie-Salmon stages of MM (P>0.05). The expression of CD56 was different among different immunoglobulin types of MM, and the types of immunoglobulin with an expression from high to low were non-secretory, IgA, IgG, and light chain (P<0.05). Conclusion The 4-color and 10-antibody flow cytometry immunophenotyping panel using 10 antibodies including CD45, CD38, CD19, CD56, CD20, CD5, CD10, HLA-DR, κ antibody and λ antibody marked by four kinds of fluorescein including PE, FITC, PerCP and APC has a good diagnostic value for MM.
ObjectiveTo analyze the efficacy, hospitalization cost and cost-effect of different treatments for multiple myeloma, so as to provide references for the treatment and development medical insurance payment policy of multiple myeloma.MethodsA total of 60 cases of multiple myeloma patients who were treated in the General Hospital of Shenyang Military Command from January 1st, 2013 to December 31st, 2017 were included. According to the treatment method, they were categorized into the traditional treatment group (n=37) and novel drug treatment group (n=23). The total response rate and hospitalisation expenses for patients with medical insurance of the two groups were calculated and compared, and cost-effectiveness analysis was then performed.ResultsThe overall response rate in patients in traditional treatment group was 56.76% (21/37), and in novel drug treatment group was 82.61% (19/23) (χ2=4.366, P=0.039). The annual average drug fee, annual average novel drug fee, secondary average drug fee, secondary average novel drug fee, annual average total cost, and secondary average total cost of the medical insurance patients in the novel drug treatment group were significantly higher than those in the traditional treatment group (P<0.05). The annual average cost of personal and coordinated payment for the medical insurance patients in the novel drug treatment group were 172 229.53 yuan and 48 237.51 yuan, respectively, which were significantly higher than the traditional treatment group (P<0.01). The cost-effectiveness ratio of the traditional treatment group was 884.44 yuan/%, the novel drug treatment group was 2 821.80 yuan/%, the cost-effective incremental ratio was 7 075.75 yuan/%, the incremental cost-effective ratio was 7 075.75 yuan/%, and the sensitivity analysis was consistent with the results.ConclusionsThe total response rate of novel drug treatment is significantly higher than traditional treatment. However, novel drug treatment costs higher, and patient's economic burden is also higher. The traditional treatment is superior to novel drug treatment in cost-effectiveness analysis.
Objective To investigate the causal relationship between resistin and multiple myeloma (MM). Methods A two-sample Mendelian randomization analysis was conducted using genetic variants (SNPs) associated with resistin as instrumental variables and MM genome-wide association study (GWAS) data as the outcome event. Five analysis methods, including inverse-variance weighted (IVW), MR-Egger, weighted median, weighted model, and simple model were used to assess the causal impact of resistin on the risk of MM. Results None of the five analysis methods showed a causal relationship between resistin and multiple myeloma (P>0.05). Sensitivity analysis indicated consistent and robust results, with no evidence of horizontal pleiotropy, heterogeneity, outliers, or individual SNPs influencing the findings. Conclusion This Mendelian randomization study provides no support for a causal relationship between resistin and the risk of multiple myeloma.