Evidence map›Paper›PMID 26250580›Full record

Trial reportHaematologica2015

Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone.

Meletios A Dimopoulos, Katja C Weisel, Kevin W Song, Michel Delforge, Lionel Karlin, Hartmut Goldschmidt, Philippe Moreau, Anne Banos, Albert Oriol, Laurent Garderet and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter 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 NCT01311687 (A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
8.8field-weighted citation impact, top 2% 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.

NCT01311687 phase3completednot on this map

A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorCelgeneRan2011 to 2017Enrolled455ConditionsMultiple MyelomaArmspomalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 72 citations in OpenAlex.

  1. Trial
  2. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
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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

25 authors at 18 institutions in 9 countries.

Meletios A DimopoulosAlexandra Hospital, Athens, Greece mdimop@med.uoa.gr.
Katja C WeiselHematology & Oncology, Department of Medicine, University Hospital Tübingen, Germany.
Kevin W SongVancouver General Hospital, Vancouver, BC, Canada.
Michel DelforgeDepartment of Hematology, University Hospital Leuven, Belgium.
Lionel KarlinCentre Hospitalier Lyon Sud/Hospices Civils de Lyon, Pierre-Bénite, France.
Hartmut GoldschmidtUniversity Hospital Heidelberg and German Cancer Research Center, Heidelberg, Germany.
Philippe MoreauHematology, University Hospital Hôtel-Dieu, Nantes, France.
Anne BanosHematology, Centre Hospitalier de la Côte Basque, Bayonne, France.
Albert OriolInstitut Catala d'Oncologia, HGTiP, Barcelona, Spain.
Laurent GarderetHopital Saint Antoine, Paris, France.
Michele CavoSeràgnoli Institute of Hematology, Bologna University School of Medicine, Italy.
Valentina IvanovaGUZ Moscow City Clinical Hospital S.P. Botkin, Russia.
Adrian AlegreHospital Universitario La Princesa, Madrid, Spain.
Joaquin Martinez-LopezHospital Universitario 12 de Octubre, Madrid, Spain.
Christine ChenPrincess Margaret Hospital, Toronto, ON, Canada.
Andrew SpencerAlfred Hospital-Monash University, Melbourne, Australia.
Stefan KnopUniversity of Würzburg, Germany.
Nizar J BahlisUniversity of Calgary, AB, Canada.
Christoph RennerUniversity Hospital Zurich, Switzerland.
Xin YuCelgene Corporation, Summit, NJ, USA.
Kevin HongCelgene Corporation, Summit, NJ, USA.
Lars SternasCelgene Corporation, Summit, NJ, USA.
Christian JacquesCelgene Corporation, Summit, NJ, USA.
Mohamed H ZakiCelgene Corporation, Summit, NJ, USA.
Jesus F San MiguelClinica Universidad de Navarra, CIMA, Pamplona, Spain.
Alexandra Hospital · GRBotkin Hospital · RUCentre Hospitalier de la Côte Basque · FRClinica Universidad de Navarra · ESGerman Cancer Research Center · DEHôpital Lyon Sud · FRHôpital Saint-Antoine · FRHospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESInstitut Català d'Oncologia · ESKU Leuven · BEMonash University · AUPrincess Margaret Cancer Centre · CAUniversity Children's Hospital Tübingen · DEUniversity Hospital of Zurich · CHUniversity of Calgary · CAUniversity of Würzburg · DEVancouver General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with refractory or relapsed and refractory multiple myeloma who no longer receive benefit from novel agents have limited treatment options and short expected survival. del(17p) and t(4;14) are correlated with shortened survival. The phase 3 MM-003 trial demonstrated significant progression-free and overall survival benefits from treatment with pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone among patients in whom bortezomib and lenalidomide treatment had failed. At an updated median follow-up of 15.4 months, the progression-free survival was 4.0 versus 1.9 months (HR, 0.50; P<0.001), and median overall survival was 13.1 versus 8.1 months (HR, 0.72; P=0.009). Pomalidomide plus low-dose dexamethasone, compared with high-dose dexamethasone, improved progression-free survival in patients with del(17p) (4.6 versus 1.1 months; HR, 0.34; P <0.001), t(4;14) (2.8 versus 1.9 months; HR, 0.49; P=0.028), and in standard-risk patients (4.2 versus 2.3 months; HR, 0.55; P<0.001). Although the majority of patients treated with high-dose dexamethasone took pomalidomide after discontinuation, the overall survival of patients treated with pomalidomide plus low-dose dexamethasone or high-dose dexamethasone was 12.6 versus 7.7 months (HR, 0.45; P=0.008) in patients with del(17p), 7.5 versus 4.9 months (HR, 1.12; P=0.761) in those with t(4;14), and 14.0 versus 9.0 months (HR, 0.85; P=0.380) in standard-risk subjects. The overall response rate was higher in patients treated with pomalidomide plus low-dose dexamethasone than in those treated with high-dose dexamethasone both among standard-risk patients (35.2% versus 9.7%) and those with del(17p) (31.8% versus 4.3%), whereas it was similar in patients with t(4;14) (15.9% versus 13.3%). The safety of pomalidomide plus low-dose dexamethasone was consistent with initial reports. In conclusion, pomalidomide plus low-dose dexamethasone is efficacious in patients with relapsed/refractory multiple myeloma and del(17p) and/or t(4;14). This study is registered at ClinicalTrials.gov as NCT01311687 and with EudraCT as 2010-019820-30.

Indexed as

Chromosome AberrationsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedMultiple MyelomaNeoplasm StagingPrognosisRecurrenceDexamethasonepomalidomideThalidomide

Identifiers

PMID26250580
PMCPMC4591765
OpenAlexW2336872381

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.