Evidence map›Paper›PMID 29435979›Full record

Trial reportBritish journal of haematology2018

Ibrutinib alone or with dexamethasone for relapsed or relapsed and refractory multiple myeloma: phase 2 trial results.

Paul G Richardson, William I Bensinger, Carol Ann Huff, Caitlin L Costello, Nikoletta Lendvai, Jesus G Berdeja, Larry D Anderson, David S Siegel, Daniel Lebovic, Sundar Jagannath and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Beyond the cell: novel noncellular immunotherapy approaches to multiple myeloma.Hematology. American Society of Hematology. Education Program · 2022
    Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Pathogenesis and Treatment of Myeloma-Related Bone Disease.International journal of molecular sciences · 2022
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Bruton's Tyrosine Kinase Targeting in Multiple Myeloma.International journal of molecular sciences · 2021
    Review
  18. Article
  19. Review
  20. Review
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

19 authors at 12 institutions in 1 country.

Paul G RichardsonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0002-7426-8865
William I BensingerClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Carol Ann HuffDepartment of Oncology, Johns Hopkins University, Baltimore, MD, USA.
Caitlin L CostelloDivision of Bone Marrow Transplantation, Moores Cancer Center, University of California San Diego, La Jolla, CA, USA.
Nikoletta LendvaiMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Jesus G BerdejaMyeloma Research, Sarah Cannon Research Institute, Nashville, TN, USA.
Larry D AndersonSimmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID 0000-0002-6531-9595
David S SiegelJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
Daniel LebovicHematology and Medical Oncology, Great Lakes Cancer Management Specialists, Grosse Pointe Woods, MI, USA.
Sundar JagannathMount Sinai Medical Center, Tisch Cancer Institute, New York, NY, USA.
Jacob P LaubachJerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0001-7565-2052
Keith E Stockerl-GoldsteinDepartment of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Long KweiPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Fong ClowPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Laurence EliasPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Zeena SalmanPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Thorsten GraefPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Elizabeth BilottiPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Ravi VijDepartment of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
AbbVie (United States) · USDana-Farber Cancer Institute · USWashington University in St. Louis · USFred Hutch Cancer Center · USGreat Lakes Cancer Management Specialists · USHackensack University Medical Center · USJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USMount Sinai Medical Center · USSarah Cannon · USThe University of Texas Southwestern Medical Center · USUniversity of California San Diego · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Novel therapies with unique new targets are needed for patients who are relapsed/refractory to current treatments for multiple myeloma. Ibrutinib is a first-in-class, once-daily, oral covalent inhibitor of Bruton tyrosine kinase, which is overexpressed in the myeloma stem cell population. This study examined various doses of ibrutinib ± low-dose dexamethasone in patients who received ≥2 prior lines of therapy, including an immunomodulatory agent. Daily ibrutinib ± weekly dexamethasone 40 mg was assessed in 4 cohorts using a Simon 2-stage design. The primary objective was clinical benefit rate (CBR; ≥minimal response); secondary objectives included safety. Patients (n = 92) received a median of 4 prior regimens. Ibrutinib + dexamethasone produced the highest CBR (28%) in Cohort 4 (840 mg + dexamethasone; n = 43), with median duration of 9·2 months (range, 3·0-14·7). Progression-free survival was 4·6 months (range, 0·4-17·3). Grade 3-4 haematological adverse events included anaemia (16%), thrombocytopenia (11%), and neutropenia (2%); grade 3-4 non-haematological adverse events included pneumonia (7%), syncope (3%) and urinary tract infection (3%). Ibrutinib + dexamethasone produced notable responses in this heavily pre-treated population. The encouraging efficacy, coupled with the favourable safety and tolerability profile of ibrutinib, supports its further evaluation as part of combination treatment.

Indexed as

AdenineAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDisease-Free SurvivalFemaleHumansMaleMiddle AgedMultiple MyelomaPiperidinesPyrazolesPyrimidinesRecurrenceSurvival RateAdenineDexamethasoneibrutinibPiperidinesPyrazolesPyrimidinesBruton tyrosine kinasedexamethasoneibrutinibmultiple myeloma

Identifiers

PMID29435979
PMCPMC5873373
OpenAlexW2792326760

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.