Evidence map›Paper›PMID 31883396›Full record

Trial reportEuropean journal of haematology2020

A phase 2 study of ibrutinib in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma.

Roman Hajek, Ludek Pour, Muhit Ozcan, Jesus Martin Sánchez, Ramon García Sanz, Achilles Anagnostopoulos, Albert Oriol, Nicola Cascavilla, Andreas Terjung, Yihua Lee and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in European journal of haematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02902965 (An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 16% 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.

NCT02902965 phase2completednot on this map

An Open-label Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorPharmacyclics Switzerland GmbHRan2016 to 2018Enrolled74ConditionsMultiple MyelomaArmsIbrutinib, Bortezomib, Dexamethasone
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Bruton's Tyrosine Kinase Targeting in Multiple Myeloma.International journal of molecular sciences · 2021
    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

14 authors at 11 institutions in 7 countries.

Roman HajekUniversity Hospital of Ostrava, Ostrava-Poruba-Poruba, Czech Republic.ORCID https://orcid.org/0000-0001-6955-6267
Ludek PourUniversity Hospital Brno, Brno, Czech Republic.
Muhit OzcanAnkara University School of Medicine, Ankara, Turkey.
Jesus Martin SánchezHospital Universitario Virgen del Rocio, Sevilla, Spain.
Ramon García SanzUniversity Hospital of Salamanca, Salamanca, Spain.
Achilles AnagnostopoulosGeneral Hospital of Thessaloniki "G. Papanikolaou,", Thessaloniki, Greece.
Albert OriolInstitut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain.
Nicola CascavillaIRCCS "Casa Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy.
Andreas TerjungPharmacyclics Switzerland GmbH, an AbbVie Company, Schaffhausen, Switzerland.
Yihua LeePharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.
Eva M BrisoPharmacyclics Switzerland GmbH, an AbbVie Company, Schaffhausen, Switzerland.
Edyta DobkowskaPharmacyclics Switzerland GmbH, an AbbVie Company, Schaffhausen, Switzerland.
Bernhard HaunsPharmacyclics Switzerland GmbH, an AbbVie Company, Schaffhausen, Switzerland.
Ivan Špička1st Department of Medicine - Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic.
ABB (Switzerland) · CHAbbVie (United States) · USAnkara University · TRCasa Sollievo della Sofferenza · ITCharles University · CZG. Papanikolaou General Hospital · GRHospital Universitario Virgen del Rocío · ESInstitut Català d'Oncologia · ESUniversidad de Salamanca · ESUniversity Hospital Brno · CZUniversity of Ostrava · CZ

Funding

Pharmacyclics LLC, an AbbVie Company
6 · The paper itself

Abstract

objectiveWe evaluated ibrutinib, a once-daily inhibitor of Bruton's tyrosine kinase, combined with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who had received 1-3 prior therapies.

methodsThis was a phase 2, single-arm, open-label, multicentre study (NCT02902965). The primary endpoint was progression-free survival (PFS).

resultsSeventy-six patients were enrolled; 74 received ≥1 dose of study treatment. After median follow-up of 19.6 months, median PFS was 8.5 months (95% CI: 6.2-10.8); median overall survival was not reached. Overall response rate was 57% (95% CI: 45-68), and median duration of response was 9.5 months (95% CI: 6.9-10.6). Grade 3/4 AEs occurred in 73% of patients and fatal AEs occurred in 15% of patients. Incidence of major haemorrhage was 5%; one patient died from cerebral haemorrhage. After an observed increased incidence of serious (42%) and fatal (11%) infections, enrolment was suspended to implement risk-minimisation measures. The safety profile was otherwise consistent with known safety profiles of the individual drugs.

conclusionIbrutinib combined with bortezomib and dexamethasone elicited clinical responses. However, efficacy assessments conducted at potential restart of enrolment indicated that the targeted PFS could not be reached with additional patient enrolment, and the study was terminated.

Indexed as

AdenineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultiple MyelomaNeoplasm StagingPiperidinesAdenineBortezomibDexamethasoneibrutinibPiperidinesbortezomibdexamethasoneibrutinibmultiple myeloma

Identifiers

PMID31883396
PMCPMC7216833
OpenAlexW2997556971

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.