Evidence map›Paper›PMID 27091875›Full record

Trial reportBlood2016

Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM.

Andrzej Jakubowiak, Massimo Offidani, Brigitte Pégourie, Javier De La Rubia, Laurent Garderet, Kamel Laribi, Alberto Bosi, Roberto Marasca, Jacob Laubach, Ann Mohrbacher and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01478048 (A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma), which is not on this map. Cited by 112 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 8 pooled it
30.9field-weighted citation impact, top 1% 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.

NCT01478048 phase2completednot on this map

A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

TypeinterventionalSponsorBristol-Myers SquibbRan2011 to 2017Enrolled185ConditionsMultiple MyelomaArmsElotuzumab, Bortezomib, Dexamethasone
3 · Its place in the literature

Who cites it

112 citing papers in PubMed, 8 syntheses or guidelines pooled it, 235 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Critical Appraisal of Published Indirect Comparisons and Network Meta-Analyses of Competing Interventions for Multiple Myeloma.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Review
  16. Review
  17. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  18. Review
  19. Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.International journal of molecular sciences · 2023
    Review
  20. Review

52 more citing papers are in PubMed but not listed here.

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

18 authors at 14 institutions in 4 countries.

Andrzej JakubowiakMyeloma Program, Section of Hematology/Oncology, University of Chicago Medical Center, Chicago, IL;ORCID 0000-0002-2597-6822
Massimo OffidaniClinica di Ematologia, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, Italy;
Brigitte PégourieCentre Hospitalier Universitaire de Grenoble-Hôpital Albert Michallon, Grenoble, France;
Javier De La RubiaHospital Universitario Doctor Peset and Universidad Católica "San Vicente Mártir," Valencia, Spain;
Laurent GarderetService d'hématologie, Hôpital Saint Antoine, Paris, France;
Kamel LaribiDepartment of Hematology, Centre Hospitalier, Le Mans, France;
Alberto BosiDepartment of Hematology, Azienda Ospedaliero Universitaria Careggi, Florence, Italy;
Roberto MarascaDepartment of Hematology, Azienda Ospedaliera Universitaria-Policlinico di Modena, Modena, Italy;
Jacob LaubachDepartment of Hematology/Oncology, Dana-Farber Cancer Institute, Boston, MA;
Ann MohrbacherDivision of Hematology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA;
Angelo Michele CarellaHematology Unit, Istituto di Ricovero e Cura a Carattere Scientifico San Martino-Istituto Scientifico Tumori, Genoa, Italy;
Anil K SinghalStatistics, AbbVie Biotherapeutics Inc, Redwood City, CA;
L Claire TsaoStatistics, AbbVie Biotherapeutics Inc, Redwood City, CA;
Mark LynchOncology Clinical Development, Bristol-Myers Squibb, Wallingford, CT;
Eric BleickardtOncology Clinical Development, Bristol-Myers Squibb, Wallingford, CT;
Ying-Ming JouGlobal Biometric Sciences, Bristol-Myers Squibb, Hopewell, NJ;
Michael RobbinsExploratory Clinical and Translational Research-Oncology, Bristol-Myers Squibb, Princeton, NJ; and.
Antonio PalumboMyeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Bristol-Myers Squibb (United States) · USAbbVie (United States) · USAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Ospedaliero-Universitaria di Modena · ITCentre Hospitalier du Mans · FRCentre Hospitalier Universitaire de Grenoble · FRDana-Farber Cancer Institute · USHospital Universitario Doctor Peset · ESIstituti di Ricovero e Cura a Carattere Scientifico · ITOspedali Riuniti di Ancona · ITSorbonne Université · FRUniversity of Chicago Medical Center · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this proof-of-concept, open-label, phase 2 study, patients with relapsed/refractory multiple myeloma (RRMM) received elotuzumab with bortezomib and dexamethasone (EBd) or bortezomib and dexamethasone (Bd) until disease progression/unacceptable toxicity. Primary endpoint was progression-free survival (PFS); secondary/exploratory endpoints included overall response rate (ORR) and overall survival (OS). Two-sided 0.30 significance level was specified (80% power, 103 events) to detect hazard ratio (HR) of 0.69. Efficacy and safety analyses were performed on all randomized patients and all treated patients, respectively. Of 152 randomized patients (77 EBd, 75 Bd), 150 were treated (75 EBd, 75 Bd). PFS was greater with EBd vs Bd (HR, 0.72; 70% confidence interval [CI], 0.59-0.88; stratified log-rank P = .09); median PFS was longer with EBd (9.7 months) vs Bd (6.9 months). In an updated analysis, EBd-treated patients homozygous for the high-affinity FcγRIIIa allele had median PFS of 22.3 months vs 9.8 months in EBd-treated patients homozygous for the low-affinity allele. ORR was 66% (EBd) vs 63% (Bd). Very good partial response or better occurred in 36% of patients (EBd) vs 27% (Bd). Early OS results, based on 40 deaths, revealed an HR of 0.61 (70% CI, 0.43-0.85). To date, 60 deaths have occurred (28 EBd, 32 Bd). No additional clinically significant adverse events occurred with EBd vs Bd. Grade 1/2 infusion reaction rate was low (5% EBd) and mitigated with premedication. In patients with RRMM, elotuzumab, an immunostimulatory antibody, appears to provide clinical benefit without added clinically significant toxicity when combined with Bd vs Bd alone. Registered to ClinicalTrials.gov as NCT01478048.

Indexed as

Drug Resistance, NeoplasmAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneFemaleHumansMaleMiddle AgedMultiple MyelomaNeoplasm Recurrence, LocalTreatment OutcomeAntibodies, Monoclonal, HumanizedBortezomibDexamethasoneelotuzumab

Identifiers

PMID27091875
PMCPMC4900953
OpenAlexW2424457748

What OpenQuestion holds

Textmetadata
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.