Evidence map›Paper›PMID 28485007›Full record

Trial reportBritish journal of haematology2017

Management of adverse events associated with ixazomib plus lenalidomide/dexamethasone in relapsed/refractory multiple myeloma.

Shaji Kumar, Philippe Moreau, Parameswaran Hari, Maria-Victoria Mateos, Heinz Ludwig, Chaim Shustik, Tamas Masszi, Andrew Spencer, Roman Hájek, Kenneth Romeril and 10 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Review
  10. Article
  11. Article
  12. Observational
  13. Ixazomib-Associated Skin Exfoliation.Mediterranean journal of hematology and infectious diseases · 2022
    Article
  14. Article
  15. Article
  16. Article
  17. Design, synthesis, andJournal of enzyme inhibition and medicinal chemistry · 2020
    Article
  18. Article
  19. Observational
  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

20 authors at 14 institutions in 10 countries.

Shaji KumarDivision of Hematology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-5392-9284
Philippe MoreauUniversity Hospital Hôtel Dieu, Nantes, France.ORCID 0000-0003-1780-8746
Parameswaran HariDivision of Hematology and Oncology, Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI, USA.
Maria-Victoria MateosServicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain.
Heinz LudwigWilhelminenspital der Stadt Wien, Vienna, Austria.
Chaim ShustikMcGill University Health Center, Royal Victoria Hospital, Montreal, Canada.
Tamas MassziDepartment of Haematology and Stem Cell Transplantation, St István and St László Hospital, Semmelweis University, Budapest, Hungary.
Andrew SpencerAlfred Health-Monash University, Melbourne, Australia.
Roman HájekDepartment of Haematooncology, University Hospital Ostrava, Ostrava, Czech Republic.
Kenneth RomerilWellington Blood and Cancer Centre, Wellington Regional Hospital, Wellington, New Zealand.
Irit AviviDepartment of Haematology and Bone Marrow Transplantation, Tel Aviv Medical Centre, Tel Aviv, Israel.
Anna M LiberatiUniversity of Perugia, SC Oncoematologia AO S. Maria di Terni, Terni, Italy.
Monique C MinnemaDepartment of Haematology, UMC Utrecht Cancer Centre, Utrecht, The Netherlands.
Hermann EinseleUniversitätsklinik Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany.ORCID 0000-0002-7680-0819
Sagar LonialDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.
Deborah BergMillennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Jianchang LinMillennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Neeraj GuptaMillennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.ORCID 0000-0002-5500-5218
Dixie-Lee EsseltineMillennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Paul G RichardsonDana-Farber Cancer Institute, Boston, MA, USA.
Takeda (United States) · USComplejo Hospitalario de Salamanca · ESDana-Farber Cancer Institute · USEmory University · USFroedtert Hospital · USMayo Clinic in Arizona · USMonash Alfred Psychiatry Research centre · AURoyal Victoria Hospital · CASemmelweis University · HUUniversity Hospital Ostrava · CZUniversity Medical Center Utrecht · NLUniversity of Perugia · ITWellington Hospital · NZWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs. 14·7 months; hazard ratio 0·74). Common toxicities observed more commonly with IRd versus placebo-Rd were thrombocytopenia, nausea, vomiting, diarrhoea, constipation, rash, peripheral neuropathy, peripheral oedema and back pain; these were generally grade 1/2 in severity except for thrombocytopenia (19% vs. 9% grade 3/4), which appeared manageable and reversible, with no differences between arms in significant bleeding or dose discontinuations. No cumulative toxicities were observed, indicating the potential feasibility of long-term IRd treatment. Safety data from TOURMALINE-MM1 are reviewed and guidance for managing clinically relevant adverse events associated with IRd is provided. Most toxicities were manageable with supportive care and dose delays or reductions as needed. Clinicians should be aware of and understand these potential side effects to optimise and prolong patient benefit.

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsDexamethasoneDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug EruptionsFollow-Up StudiesGlycineHematologic DiseasesHumansLenalidomideBoron CompoundsDexamethasoneGlycineixazomibLenalidomideThalidomidedosingixazomibmultiple myelomaproteasome inhibitortoxicity

Identifiers

PMID28485007
PMCPMC5574012
OpenAlexW2614011808

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.