Evidence map›Paper›PMID 31588567›Full record

Trial reportBritish journal of haematology2020

Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure.

David S Siegel, Gary J Schiller, Kevin W Song, Richy Agajanian, Keith Stockerl-Goldstein, Hakan Kaya, Michael Sebag, Christy Samaras, Ehsan Malek, Giampaolo Talamo and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of haematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01946477 (A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 4% 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.

NCT01946477 phase2completednot on this map

A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.

TypeinterventionalSponsorCelgeneRan2014 to 2025Enrolled186ConditionsMultiple MyelomaArmsPomalidomide, Dexamethasone, Daratumumab
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

David S SiegelJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.ORCID 0000-0002-3604-2574
Gary J SchillerDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Kevin W SongVancouver General Hospital, Vancouver, BC, Canada.
Richy AgajanianThe Oncology Institute of Hope and Innovation, Downey, CA, USA.
Keith Stockerl-GoldsteinWashington University School of Medicine, St. Louis, MO, USA.
Hakan KayaCancer Care Northwest, Spokane, WA, USA.
Michael SebagMcGill University Health Centre, Montreal, QC, Canada.
Christy SamarasCleveland Clinic, Cleveland, OH, USA.
Ehsan MalekUniversity Hospitals Case Medical Center, Cleveland, OH, USA.
Giampaolo TalamoPenn State Hershey Cancer Institute, Hershey, PA, USA.
Christopher S SeetDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Jorge MouroCelgene Corporation, Summit, NJ, USA.
William E PierceallCelgene Corporation, Summit, NJ, USA.
Faiza ZafarCelgene Corporation, Summit, NJ, USA.
Weiyuan ChungCelgene Corporation, Summit, NJ, USA.
Shankar SrinivasanCelgene Corporation, Summit, NJ, USA.
Amit AgarwalCelgene Corporation, Summit, NJ, USA.
Nizar J BahlisUniversity of Calgary, Calgary, AB, Canada.
University of California, Los Angeles · USCancer Care Northwest · USCleveland Clinic · USHackensack University Medical Center · USMcGill University Health Centre · CAOncology Institute of Hope and Innovation · USPenn State Milton S. Hershey Medical Center · USUniversity Hospitals Cleveland Medical Center · USUniversity of Calgary · CAVancouver General Hospital · CAWashington University in St. Louis · US

Funding

Celgene Corporation
6 · The paper itself

Abstract

Patients with relapsed/refractory multiple myeloma (RRMM) for whom the benefits of lenalidomide have been exhausted in early treatment lines need effective therapies. In cohort A of the phase 2 MM-014 trial, we examined the safety and efficacy of pomalidomide plus low-dose dexamethasone immediately after lenalidomide-based treatment failure in patients with RRMM and two prior lines of therapy. Pomalidomide 4 mg was given on days 1 to 21 of 28-day cycles. Dexamethasone 40 mg (20 mg for patients aged >75 years) was given on days 1, 8, 15 and 22 of 28-day cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The intention-to-treat population comprised 56 patients; all received prior lenalidomide (87·5% lenalidomide refractory) and 39 (69·6%) received prior bortezomib. ORR was 32·1% (28·2% in the prior-bortezomib subgroup). Median PFS was 12·2 months (7·9 months in the prior-bortezomib subgroup). Median OS was 41·7 months (38·6 months in the prior-bortezomib subgroup). The most common grade 3/4 treatment-emergent adverse events were anaemia (25·0%), pneumonia (14·3%) and fatigue (14·3%). These findings support earlier sequencing of pomalidomide-based therapy in lenalidomide-pretreated patients with RRMM, including those who have become refractory to lenalidomide. Trial registration: www.ClinicalTrials.gov identifier NCT01946477.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDisease-Free SurvivalFemaleHumansLenalidomideMaleMiddle AgedMultiple MyelomaSurvival RateThalidomideDexamethasoneLenalidomidepomalidomideThalidomidedexamethasonelenalidomidemultiple myelomapomalidomiderefractory

Identifiers

PMID31588567
PMCPMC7027539
OpenAlexW2978510275

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.