Evidence map›Paper›PMID 27226434›Full record

Trial reportBlood2016

Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma.

Meletios A Dimopoulos, Antonio Palumbo, Paolo Corradini, Michele Cavo, Michel Delforge, Francesco Di Raimondo, Katja C Weisel, Albert Oriol, Markus Hansson, Angelo Vacca and 21 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01712789 (A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma), which is not on this map. Cited by 79 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 2 pooled it
17.7field-weighted citation impact, top 1% 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.

NCT01712789 phase3completednot on this map

A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorCelgeneRan2012 to 2019Enrolled682ConditionsMultiple MyelomaArmsPomalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 2 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Pooled it
  2. Critical Appraisal of Published Indirect Comparisons and Network Meta-Analyses of Competing Interventions for Multiple Myeloma.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020
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  11. Melflufen and Dexamethasone in Heavily Pretreated Relapsed and Refractory Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
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19 more citing papers are in PubMed but not listed here.

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

31 authors at 20 institutions in 11 countries.

Meletios A DimopoulosNational and Kapodistrian University of Athens, Athens, Greece.
Antonio PalumboUniversity of Turin, Turin, Italy;
Paolo CorradiniUniversity of Milan, Fondazione IRCCS Istituto Nazionale de Tumori, Milan, Italy;
Michele CavoBologna University School of Medicine, Bologna, Italy;
Michel DelforgeUniversity Hospital Leuven, Leuven, Belgium;
Francesco Di RaimondoUniversity of Catania, Catania, Italy;
Katja C WeiselUniversity Hospital of Tuebingen, Tuebingen, Germany;
Albert OriolInstitut Català d'Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain;
Markus HanssonSkane University Hospital, Lund University, Lund, Sweden;
Angelo VaccaUniversity of Bari Medical School, Bari, Italy;
María Jesús BlanchardHospital Ramón y Cajal, Madrid, Spain.
Hartmut GoldschmidtUniversity Hospital Heidelberg and German Cancer Research Center, Heidelberg, Germany.
Chantal DoyenUniversité Catholique de Louvain, Centre Hospitalier Universitaire, Université Catholique de Louvain Namur, Yvoir, Belgium;
Martin KaiserThe Royal Marsden Hospital, Surrey, United Kingdom;
Mario PetriniSanta Chiara Hospital, University of Pisa, Pisa, Italy;
Pekka AnttilaHelsinki University Hospital Comprehensive Cancer Center and University of Helsinki, Helsinki, Finland;
Anna Maria CafroHospedale Niguarda Ca' Granda, Milan, Italy;
Reinier RaymakersUniversity Medical Center Utrecht, Utrecht, The Netherlands;
Jesus San-MiguelClinica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain;
Felipe de ArribaHospital General Universitario Morales Meseguer, Murcia, Spain;
Stefan KnopWurzburg University Medical Center, Wurzburg, Germany;
Christoph RölligUniversitatsklinikum, Medizinsche Klinik und Poliklinik I, Dresden, Germany;
Enrique M OcioComplejo Asistencial Universitario de Salamanca Centro Investigación del Cáncer-Instituto de Biología Molecular y Celular del Cancer) Cancer Research Center, Salamanca, Spain;
Gareth MorganMyeloma Institute for Research and Therapy, University of Arkansas Medical School, Little Rock, AR;
Neil MillerCelgene International Sàrl, Boudry, Switzerland;
Mathew SimcockCelgene International Sàrl, Boudry, Switzerland;
Teresa PelusoCelgene International Sàrl, Boudry, Switzerland;
Jennifer HerringCelgene Corporation, Summit, NJ; and.
Lars SternasCelgene Corporation, Summit, NJ; and.
Mohamed H ZakiCelgene Corporation, Summit, NJ; and.
Philippe MoreauUniversity Hospital Hotel-Dieu, Nantes, France.
Bristol-Myers Squibb (Switzerland) · CHAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITComplejo Hospitalario de Salamanca · ESGerman Cancer Research Center · DEHospital General Universitario Morales Meseguer · ESHospital Universitario Ramón y Cajal · ESInstitut Català d'Oncologia · ESKU Leuven · BENational and Kapodistrian University of Athens · GRNavarre Institute of Health Research · ESRoyal Marsden Hospital · GBSkåne University Hospital · SEUCLouvain · BEUniversity Medical Center Utrecht · NLUniversity of Arkansas for Medical Sciences · USUniversity of Bari Aldo Moro · ITUniversity of Bologna · ITUniversity of Catania · ITUniversity of Helsinki · FIUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. www.Clinicaltrials.gov identifier NCT01712789.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple MyelomaThalidomideDexamethasonepomalidomideThalidomide

Identifiers

PMID27226434
PMCPMC5009959
OpenAlexW2394652810

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.