Evidence map›Paper›PMID 28683766›Full record

Trial reportJournal of hematology & oncology2017

Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study.

Jian Hou, Jie Jin, Yan Xu, Depei Wu, Xiaoyan Ke, Daobin Zhou, Jin Lu, Xin Du, Xiequn Chen, Junmin Li and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01564537 (A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib), which is not on this map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
–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.

NCT01564537 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

TypeinterventionalSponsorTakedaRan2012 to 2022Enrolled722ConditionsRelapsed Multiple Myeloma, Refractory Multiple MyelomaArmsIxazomib, Lenalidomide, Dexamethasone, Placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Observational
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

21 authors.

Jian HouDepartment of Hematology, Chang Zheng Hospital, The Second Military Medical University, Shanghai, 200003, China. houjian167@sohu.com.
Jie JinFirst Hospital Affiliated Zhe Jiang Medical University, Hangzhou, China.
Yan XuInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Tianjin, China.
Depei WuThe First Affiliated Hospital of Soochow University, Jiangsu, China.
Xiaoyan KeThe Third Affiliated Hospital of Beijing Medical University, Beijing, China.
Daobin ZhouPeking Union Medical College Hospital, Beijing, China.
Jin LuPeking University People's Hospital, Beijing, China.
Xin DuGuangdong General Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.
Xiequn ChenXijing Hospital, The Fourth Military Medical University, Xi'an, China.
Junmin LiRuijin Hospital, Shanghai Jiao Tong University, Shanghai, China.
Jing LiuThe Third Hospital Xiang Ya Medical University, Changsha, China.
Neeraj GuptaMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Michael J HanleyMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Hongmei LiMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Zhaowei HuaMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Bingxia WangMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Xiaoquan ZhangMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Hui WangMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Helgi van de VeldeMillennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.), Cambridge, MA, USA.
Paul G RichardsonDana-Farber Cancer Institute, Boston, MA, USA.
Philippe MoreauUniversity Hospital Hôtel-Dieu, Nantes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe China Continuation study was a separate regional expansion of the global, double-blind, placebo-controlled, randomized phase III TOURMALINE-MM1 study of ixazomib plus lenalidomide-dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM) following one to three prior therapies.

methodsPatients were randomized (1:1) to receive ixazomib 4.0 mg or placebo on days 1, 8, and 15, plus lenalidomide 25 mg on days 1-21 and dexamethasone 40 mg on days 1, 8, 15, and 22, in 28-day cycles. Randomization was stratified according to number of prior therapies, disease stage, and prior proteasome inhibitor exposure. The primary endpoint was progression-free survival (PFS). In total, 115 Chinese patients were randomized (57 ixazomib-Rd, 58 placebo-Rd).

resultsAt the preplanned final analysis for PFS, after median PFS follow-up of 7.4 and 6.9 months, respectively, PFS was improved with ixazomib-Rd versus placebo-Rd (median 6.7 vs 4.0 months; HR 0.598; p = 0.035). At the preplanned final analysis of overall survival (OS), after median follow-up of 20.2 and 19.1 months, respectively, OS was improved with ixazomib-Rd versus placebo-Rd (median 25.8 vs 15.8 months; HR 0.419; p = 0.001). On the ixazomib-Rd and placebo-Rd arms, respectively, 38 (67%) and 43 (74%) patients reported grade ≥3 adverse events (AEs), 19 (33%) and 18 (31%) reported serious AEs, and 4 (7%) and 5 (9%) died on-study. The most frequent grade 3/4 AEs were thrombocytopenia (18%/7% vs 14%/5%), neutropenia (19%/5% vs 19%/2%), and anemia (12%/0 vs 26%/2%).

conclusionsThis study demonstrated that PFS and OS were significantly improved with ixazomib-Rd versus placebo-Rd, with limited additional toxicity, in patients with RRMM.

trial registrationClinicalTrials.gov, NCT01564537.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsChinaDexamethasoneDisease-Free SurvivalDouble-Blind MethodFemaleGlycineHumansLenalidomideMaleMiddle AgedMultiple MyelomaAngiogenesis InhibitorsBoron CompoundsDexamethasoneGlycineixazomibLenalidomideThalidomideChinaIxazomibMultiple myelomaOralOverall survivalProgression-free survivalProteasome inhibitorRelapsed/refractory

Identifiers

PMID28683766
PMCPMC5500972

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.