Evidence map›Paper›PMID 31280348›Full record

Trial reportJournal of cancer research and clinical oncology2019

A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients.

Feng Li, Fu-Sheng Yao, Xi-Jun Zhu, Wei-Ying Gu, Xiao-Hua Wang, Bing Chen, Dong-Ping Huang, Jia-Hua Ding, Tian-Qin Wu, Yan Zhu and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02086942 (Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02086942 phase2unknown statusnot on this map

Randomized, Multicenter Study of Tolerability and Efficacy of Modified Combinations of Bortezomib, Dexamethasone and Cyclophosphamide in Previously Untreated Multiple Myeloma.

TypeinterventionalSponsorYongping ZhaiRan2013 to 2017Enrolled94ConditionsMultiple MyelomaArmsBortezomib, cyclophosphamide, Dexamethasone
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Feng LiDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Fu-Sheng YaoDepartment of Hematology, An Qing Municipal Hospital, Anqing, Anhui, People's Republic of China.
Xi-Jun ZhuDepartment of Hematology, Xuancheng People's Hospital, Xuancheng, Anhui, People's Republic of China.
Wei-Ying GuDepartment of Hematology, The First People's Hospital of Changzhou, Third Affiliated to Suzhou University, Changzhou, Jiangsu, People's Republic of China.
Xiao-Hua WangDepartment of Hematology, The Second People's Hospital of Wuhu, Wuhu, Anhui, People's Republic of China.
Bing ChenDepartment of Hematology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, 210008, Jiangsu, People's Republic of China.
Dong-Ping HuangDepartment of Hematology, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, People's Republic of China.
Jia-Hua DingDepartment of Hematology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, People's Republic of China.
Tian-Qin WuDepartment of Hematology, The 904th Hospital of Chinese People's Liberation Army, Suzhou, Jiangsu, People's Republic of China.
Yan ZhuDepartment of Hematology, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, People's Republic of China.
Qian ZhaoDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Yu-Mei TangDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Ping SongDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Xiao-Gang ZhouDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Zhi-Ming AnDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Xing GuoDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Xu-Li WangDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China.
Long ZhongDepartment of Hematology, An Qing Municipal Hospital, Anqing, Anhui, People's Republic of China.
Xiao-Bao XieDepartment of Hematology, The First People's Hospital of Changzhou, Third Affiliated to Suzhou University, Changzhou, Jiangsu, People's Republic of China.
Yong-Ping ZhaiDepartment of Hematology, Jinling Hospital, School of Medicine, Nanjing University, 305 Zhongshan EAST Rd, Nanjing, 210002, Jiangsu, People's Republic of China. yongpingzhai@163.com.ORCID http://orcid.org/0000-0002-7711-7210

Funding

the National Natural Science Foundation of China for Young Scholars 81800126the Six Talent Peak Project in Jiangsu Province 2015-WSN-011
6 · The paper itself

Abstract

purposeCombinations of bortezomib (Velcade), cyclophosphamide and dexamethasone have shown significant efficacy and safety for patients of newly diagnosed multiple myeloma (NDMM). In this study, we compared the efficacy and safety of modified VCD regimens with novel changes in bortezomib dose and schedule for NDMM.

methodsEighty-five NDMM patients from multiple centers were randomly assigned to a high-dose (1.6 mg/m

resultsAfter four cycles, complete response (CR) or better in group A (43.6%) was higher than that in group B (12.8%) (P = 0.002). During induction, for patients with R-ISS stage III, the CR or better rate in group A was superior to that in group B (P = 0.01). Of patients < 65, the CR or better rate of group A was superior to that of group B (P = 0.004). Rapid onset of CR occurred in group A (P < 0.01). Meanwhile, rate of 3-4 diarrhea was higher in group A (P = 0.03), which caused higher rate of dose reduction for patients ≥ 65 (P = 0.041). No significant difference between the two groups in PFS and OS.

conclusionsThe studied high-dose VCD as induction regimen had an improved CR rate, especially in patients < 65 or with R-ISS stage III, and is feasible for young and high-risk patients. Trial registration ClinicalTrials.gov: NCT02086942.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibCyclophosphamideDexamethasoneDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMaleMiddle AgedMultiple MyelomaTeniposideBortezomibCyclophosphamideDexamethasoneTeniposideBortezomibDifferent dosesEfficacyMultiple myelomaSubcutaneous injection

Identifiers

PMID31280348
PMCPMC11810315

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.