Evidence map›Paper›PMID 34496096›Full record

Trial reportEuropean journal of haematology2022

Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics.

Paul G Richardson, Fredrik Schjesvold, Katja Weisel, Philippe Moreau, Larry D Anderson, Darrell White, Paula Rodriguez-Otero, Pieter Sonneveld, Monika Engelhardt, Matthew Jenner and 18 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01734928 (A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
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.

NCT01734928 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorCelgeneRan2013 to 2022Enrolled559ConditionsMultiple MyelomaArmsPomalidomide, Bortezomib, Dexamethasone
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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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

28 authors at 20 institutions in 13 countries.

Paul G RichardsonDepartment of Medical Oncology, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
Fredrik SchjesvoldOslo Myeloma Center at Oslo University Hospital, KG Jebsen Center for B-Cell Malignancies, University of Oslo, Oslo, Norway.ORCID https://orcid.org/0000-0003-1096-0569
Katja WeiselDepartment of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Philippe MoreauUniversity Hospital Hôtel-Dieu, Nantes, France.ORCID https://orcid.org/0000-0003-1780-8746
Larry D AndersonUniversity of Texas Southwestern Medical Center, Dallas, Texas, USA.
Darrell WhiteDalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.
Paula Rodriguez-OteroClinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain.
Pieter SonneveldErasmus MC Cancer Institute, Rotterdam, The Netherlands.
Monika EngelhardtUniversitätsklinikum Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0003-0405-1676
Matthew JennerSouthampton General Hospital, Southampton, UK.
Alessandro CorsoPoliclinico San Matteo Universita Di Pavia, Pavia, Italy.
Jan DürigUniversity Hospital Essen, Essen, Germany.
Michel PavicCentre Hospitalier Universitaire De Sherbrooke (CHUS), Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont, Sherbrooke, QC, Canada.
Morten SalomoCopenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Meral BeksacAnkara University, Ankara, Turkey.
Albert OriolInstitut Català d'Oncologia I Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Spain.ORCID https://orcid.org/0000-0001-6804-2221
Jindriska LindsayEast Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK.
Anna Marina LiberatiUniversity of Perugia, Perugia, Italy.
Monica GalliOspedale Papa Giovanni XXIII, U.O. di Ematologia, Ispedali Riuniti di Bergamo, Bergamo, Italy.
Pawel RobakMedical University of Lodz, Lodz, Poland.
Alessandra LaroccaA.O.U. Citta della Salute e della Scienza di Torino, Torino, Italy.
Munci YagciGazi University Medical Faculty, Ankara, Turkey.
Filiz VuralEge University, Izmir, Turkey.
Abraham S KanateWest Virginia University, Morgantown, West Virginia, USA.
Ruiyun JiangBristol Myers Squibb, Princeton, New Jersey, USA.
Lara GroteBristol Myers Squibb, Princeton, New Jersey, USA.
Teresa PelusoCelgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland.
Meletios DimopoulosNational and Kapodistrian University of Athens, Athens, Greece.ORCID https://orcid.org/0000-0001-8990-3254
Bristol-Myers Squibb (United States) · USAnkara University · TRAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITBristol-Myers Squibb (Switzerland) · CHCentre Hospitalier Universitaire de Sherbrooke · CAClinica Universidad de Navarra · ESCopenhagen University Hospital · DKDalhousie University · CAEast Kent Hospitals University NHS Foundation Trust · GBEge University · TRErasmus MC Cancer Institute · NLEssen University Hospital · DEGazi University · TRHarvard University · USInstitut Català d'Oncologia · ESMedical University of Lodz · PLNational and Kapodistrian University of Athens · GROslo University Hospital · NOOspedale Papa Giovanni XXIII · ITSouthampton General Hospital · GB

Funding

Bristol-Myers Squibb
6 · The paper itself

Abstract

objectiveWe evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.

methodsOPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).

resultsOverall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.

conclusionsThese findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleHumansLenalidomideMaleMiddle AgedMultiple MyelomaPrognosisRecurrenceRetreatmentThalidomideBortezomibDexamethasoneLenalidomidepomalidomideThalidomideagedchromosome aberrationsmultiple myelomapomalidomiderenal insufficiency

Identifiers

PMID34496096
PMCPMC9293199
OpenAlexW3197669971

What OpenQuestion holds

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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.