Evidence map›Paper›PMID 26153365›Full record

Trial reportBritish journal of haematology2015

Bortezomib, thalidomide and dexamethasone, with or without cyclophosphamide, for patients with previously untreated multiple myeloma: 5-year follow-up.

Heinz Ludwig, Richard Greil, Tamas Masszi, Ivan Spicka, Ofer Shpilberg, Roman Hajek, Anna Dmoszynska, Bruno Paiva, María-Belén Vidriales, Graca Esteves and 8 more

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

Trial report in British journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00531453 (A Phase 2, Randomized Study of VELCADE®), which is not on this map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
3.4field-weighted citation impact, top 8% 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.

NCT00531453 phase2completednot on this map

A Phase 2, Randomized Study of VELCADE® (Bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (Bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who Are Candidates for Autologous Transplantation

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2007 to 2009Enrolled98ConditionsMultiple MyelomaArmsbortezomib, dexamethasone, and thalidomide, bortezomib, dexamethasone, thalidomide, and cyclophosphamide
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Is molecular remission the goal of multiple myeloma therapy?Hematology. American Society of Hematology. Education Program · 2017
    Review
  15. Review
  16. Article
  17. 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

18 authors at 15 institutions in 11 countries.

Heinz Ludwigc/o First Department of Medicine, Centre for Oncology, Haematology and Palliative Care, Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.
Richard GreilLandeskrankenhaus, Universitätsklinik für Innere Medizin III, Salzburg, Austria.
Tamas MassziDepartment of Haematology and Stem Cell Transplantation, St István and St László Hospital, Budapest, Hungary.
Ivan SpickaFirst Faculty of Medicine, First Medical Department, Clinical Department of Haematology, Charles University in Prague, Prague, Czech Republic.
Ofer ShpilbergInstitute of Haematology, Assuta Medical Centre, Tel-Aviv, Israel.
Roman HajekDepartment of Haemato-oncology, FN Ostrava and Faculty of Medicine, Ostrava, Czech Republic.
Anna DmoszynskaMedical University of Lublin, Lublin, Poland.
Bruno PaivaCentro de Investigación Médica Aplicada (CIMA), Clínica Universidad de Navarra, Pamplona, Spain.
María-Belén VidrialesIBMCC (USAL-CSIC), Hospital Universitario Salamanca, CIC, Salamanca, Spain.
Graca EstevesHospital de Dia de Hematologia, Hospital de Santa Maria, Lisbon, Portugal.
Anne Marie StoppaInstitut Paoli-Calmettes, Marseille, France.
Don RobinsonJanssen Global Services, LLC, Raritan, NJ, USA.
Shalini ChaturvediJanssen Research & Development, LLC, Spring House, PA, USA.
Ozlem AtamanDivision of Janssen-Cilag Limited, Janssen Research & Development, High Wycombe, UK.
Christopher EnnyJanssen Research & Development, LLC, Spring House, PA, USA.
Huaibao FengJanssen Research & Development, LLC, Spring House, PA, USA.
Helgi van de VeldeJanssen Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium.
Luisa ViterboServiço de Onco-Hematologia, Instituto Português de Oncologia do Porto Francisco Gentil, Entidade Pública Empresarial (IPOPFG, EPE), Porto, Portugal.
Janssen (United States) · USJanssen (Belgium) · BEAssuta Medical Center · ILCharles University · CZClinica Universidad de Navarra · ESConsejo Superior de Investigaciones Científicas · ESHospital de Santa Maria · PTInstitut Paoli-Calmettes · FRIPO Porto · PTJanssen (United Kingdom) · GBMedical University of Lublin · PLSalzburger Landeskliniken · ATUnified Szent István and Szent László Hospital · HUUniversity of Ostrava · CZWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This follow-up extension of a randomised phase II study assessed differences in long-term outcomes between bortezomib-thalidomide-dexamethasone (VTD) and VTD-cyclophosphamide (VTDC) induction therapy in multiple myeloma. Newly diagnosed patients (n = 98) were randomised 1:1 to intravenous bortezomib (1·3 mg/m(2); days 1, 4, 8, 11), thalidomide (100 mg; days 1-21), and dexamethasone (40 mg; days 1-4, 9-12), with/without cyclophosphamide (400 mg/m(2); days 1, 8), for four 21-day cycles before stem-cell mobilisation/transplantation. After a median follow-up of 64·8 months, median time-to-next therapy was 51·8 and 47·9 months with VTD and VTDC, respectively. Type of subsequent therapy was similar in both arms. After adjusting for asymmetric censoring, median time to progression was not significantly different between VTD and VTDC [35·7 vs. 34·5 months; Hazard ratio (HR) 1·26, 95% confidence interval: 0·76-2·09; P = 0·370]. Five-year survival was 69·1% and 65·3% with VTD and VTDC, respectively. When analysed by minimal residual disease (MRD) status, overall survival was longer in MRD-negative versus MRD-positive patients with bone marrow-confirmed complete response (HR 3·66, P = 0·0318). VTD induction followed by transplantation provides long-term disease control and, consistent with the primary analysis, there is no additional benefit from adding cyclophosphamide. This study was registered at ClinicalTrials.gov (NCT00531453).

Indexed as

Induction ChemotherapyStem Cell TransplantationAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAutograftsBortezomibCyclophosphamideDexamethasoneDisease-Free SurvivalFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple MyelomaBortezomibCyclophosphamideDexamethasoneThalidomideminimal residual diseasemultiple myelomatransplantation

Identifiers

PMID26153365
PMCPMC4758383
OpenAlexW1556316630

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.