Evidence map›Paper›PMID 24833354›Full record

Trial reportBlood2014

Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti-IL-6) in multiple myeloma.

Jesús San-Miguel, Joan Bladé, Ofer Shpilberg, Sebastian Grosicki, Frédéric Maloisel, Chang-Ki Min, Marta Polo Zarzuela, Tadeusz Robak, Sripada V S S Prasad, Yeow Tee Goh and 11 more

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

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00911859 (A Randomized, Open-Label, Phase 2 Study of CNTO 328), which is not on this map. Cited by 71 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 6 pooled it
10.8field-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.

NCT00911859 phase2completednot on this map

A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2009 to 2013Enrolled118ConditionsMultiple MyelomaArmsSiltuximab11 mg/kg, Siltuximab 8.3 mg/kg or 11 mg/kg, Velcade (bortezomib), Melphalan, Prednisone
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 6 syntheses or guidelines pooled it, 140 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Pooled it
  7. Trial
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  10. Review
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  12. Article
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  15. Article
  16. Review
  17. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
    Review
  18. Optimizing high dose melphalan.Blood reviews · 2024
    Review
  19. Review
  20. Review

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

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

21 authors at 15 institutions in 10 countries.

Jesús San-MiguelCentro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;
Joan BladéInstitut d'Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;
Ofer ShpilbergSackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;
Sebastian GrosickiOddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;
Frédéric MaloiselClinique Saint Anne, Strasbourg, France;
Chang-Ki MinSeoul St. Mary's Hospital, Seoul, Republic of Korea;
Marta Polo ZarzuelaHospital Clinico San Carlos, Madrid, Spain;
Tadeusz RobakMedical University of Lodz, Lodz, Poland;
Sripada V S S PrasadApollo Hospitals & Research Foundation, Hyderabad, India;
Yeow Tee GohSingapore General Hospital, Singapore, Singapore;
Jacob LaubachDana Farber Cancer Institute, Boston, MA;
Andrew SpencerAlfred Health-Monash University, Melbourne, Australia;
María-Victoria MateosHospital Universitario Salamanca, Salamanca, Spain;
Antonio PalumboOspedale Le Molinette, Torino, Italy;
Tom PuchalskiJanssen Research & Development, Spring House, PA;
Manjula ReddyJanssen Research & Development, Spring House, PA;
Clarissa UhlarJanssen Research & Development, Spring House, PA;
Xiang QinJanssen Research & Development, Spring House, PA;
Helgi van de VeldeJanssen Research & Development, Beerse, Belgium; and.
Hong XieJanssen Research & Development, Spring House, PA;
Robert Z OrlowskiThe University of Texas MD Anderson Cancer Center, Houston, TX.
Janssen (United States) · USAlfred Health · AUApollo Hospitals · INClinica Universidad de Navarra · ESComplejo Hospitalario de Salamanca · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESDana-Farber Cancer Institute · USFondazione Ricerca Molinette · ITHospital Clínico San Carlos · ESJanssen (Belgium) · BEMedical University of Lodz · PLSeoul St. Mary's Hospital · KRSingapore General Hospital · SGTel Aviv University · ILThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
P4 -TARGETING MULTIPLE MYELOMA BY COMBINING CDK INHIBITORS AND BCL-2 ANTAGONISTSP50CA142509 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KWAK, LARRY W · 2010 to 2014
$11.1M
Dual Proteasome and MAPK Inhibition in Cancer TherapyR01CA102278 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ORLOWSKI, ROBERT ZYGMUNT · 2004 to 2008
$1.2M
NCATS NIH HHS UL1 TR000371NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA142509NCI NIH HHS R01 CA102278
6 · The paper itself

Abstract

Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (P = .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ≥3 adverse-event incidence was 92% on S+VMP and 81% on VMP (P = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion, the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes. This study was registered at http://clinicaltrials.gov as #NCT00911859.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibChromosome DeletionChromosomes, Human, Pair 17Disease-Free SurvivalFemaleFollow-Up StudiesHumansImmunoglobulin AInterleukin-6Interleukin-6 InhibitorsMaleAntibodies, MonoclonalBoronic AcidsBortezomibIL6 protein, humanImmunoglobulin AInterleukin-6Interleukin-6 InhibitorsMelphalanPrednisonePyrazinessiltuximab

Identifiers

PMID24833354
PMCPMC4123433
OpenAlexW2158759120

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.