Evidence map›Paper›PMID 26069291›Full record

Trial reportHaematologica2015

Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.

Ramón García-Sanz, Albert Oriol, María J Moreno, Javier de la Rubia, Angel R Payer, Miguel T Hernández, Luis Palomera, Ana I Teruel, María J Blanchard, Mercedes Gironella and 9 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01087008 (Assessment of the Antitumour Effect of Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
1.5field-weighted citation impact, top 17% 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.

NCT01087008 phase4completednot on this map

Assessment of the Antitumour Effect of Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse: Prospective Clinical Trial of the GEM/PETHEMA Group

TypeinterventionalSponsorPETHEMA FoundationRan2010 to 2013Enrolled103ConditionsMultiple MyelomaArmszoledronic acid, No treatment control
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Bisphosphonates in multiple myeloma: an updated network meta-analysis.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Use of bisphosphonates in multiple myeloma patients in Denmark, 2005-2015.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  14. Review
  15. How I treat a refractory myeloma patient who is not eligible for a clinical trial.Hematology. American Society of Hematology. Education Program · 2019
    Article
  16. Observational
  17. Article
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 15 institutions in 1 country.

Ramón García-SanzHospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain rgarcias@usal.es.
Albert OriolICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain.
María J MorenoHospital Morales Meseguer, Spain.
Javier de la RubiaHospital Universitario La Fe and Universidad Católica de Valencia, Spain.
Angel R PayerHospital Universitario Central de Asturias, Spain.
Miguel T HernándezHospital Universitario de Canarias, Spain.
Luis PalomeraHospital Lozano Blesa de Zaragoza, Spain.
Ana I TeruelHospital Clínico Universitario de Valencia, Spain.
María J BlanchardHospital Universitario Ramón y Cajal de Madrid, Spain.
Mercedes GironellaHospital Universitario Vall de Hebrón de Barcelona, Spain.
Paz RibasHospital Universitario Dr. Peset de Valencia, Spain.
Joan BargayHospital Son Llàtzer de Palma de Mallorca, Spain.
Eugenia AbelláHospital del Mar de Barcelona, Spain.
Miquel GranellHospital de la Santa Creu i Sant Pau de Barcelona, Spain.
Enrique M OcioHospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain.
Josep M RiberaICO - Hospital Germans Trias i Pujol, Fundació Josep Carreras, Spain.
Jesús F San MiguelClínica Universidad de Navarra-CIMA, Spain.
María V MateosHospital Universitario de Salamanca-IBSAL, IBMCC (USAL-CSIC), Spain.
Spanish Myeloma Group (GEM/PETHEMA)
Centro de Investigación del Cáncer · ESClinica Universidad de Navarra · ESHospital Clínico Universitario de Valencia · ESHospital Clínico Universitario Lozano Blesa · ESHospital Del Mar · ESHospital de Sant Pau · ESHospital General Universitario Morales Meseguer · ESHospital Son Llatzer · ESHospital Universitario Central de Asturias · ESHospital Universitario de Canarias · ESHospital Universitario Doctor Peset · ESHospital Universitario Ramón y Cajal · ESInstituto de Investigación Biomédica de Salamanca · ESValencia Catholic University Saint Vincent Martyr · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P<0.001). In summary, zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma, but does reduce the risk of progression with symptomatic bone disease and skeletal complications. This trial was registered in the ClinicalTrials.gov database with code NCT01087008.

Indexed as

Bone DiseasesDiphosphonatesImidazolesMultiple MyelomaAdultAgedDisease-Free SurvivalHumansMiddle AgedSurvival RateZoledronic AcidDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID26069291
PMCPMC4800701
OpenAlexW2180996939

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.