Evidence map›Paper›PMID 24421329›Full record

Trial reportBlood2014

Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study.

Paul G Richardson, David S Siegel, Ravi Vij, Craig C Hofmeister, Rachid Baz, Sundar Jagannath, Christine Chen, Sagar Lonial, Andrzej Jakubowiak, Nizar Bahlis and 14 more

Erratum issued 3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 173 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
173citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT00833833 phase1 / phase2completednot on this map

A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma Who Have Received Prior Treatment That Includes Lenalidomide And Bortezomib

TypeinterventionalSponsorCelgene CorporationRan2008 to 2015Enrolled259ConditionsMultiple MyelomaArmsPomalidomide, Dexamethasone, Aspirin
NCT02661022 phase1 / phase2terminatednot on this mapstarted 2016, after this paper: background citation

A Phase 1/2 Open Label Study of SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorStemline Therapeutics, Inc.Ran2016 to 2019Enrolled9ConditionsMultiple MyelomaArmsSL-401 7 µg/kg/day, SL-401 9 µg/kg/day
NCT05199311 phase1 / phase2suspendednot on this mapstarted 2022, after this paper: background citation

A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma

TypeinterventionalSponsorHackensack Meridian HealthRan2022 to 2027Enrolled66ConditionsMultiple MyelomaArmsCarfilzomib, Iberdomide, Oral Dexamethasone
3 · Its place in the literature

Who cites it

173 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  5. 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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113 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

24 authors.

Paul G RichardsonDana-Farber Cancer Institute, Boston, MA;
David S Siegel
Ravi Vij
Craig C Hofmeister
Rachid Baz
Sundar Jagannath
Christine Chen
Sagar Lonial
Andrzej Jakubowiak
Nizar Bahlis
Kevin Song
Andrew Belch
Noopur Raje
Chaim Shustik
Suzanne Lentzsch
Martha Lacy
Joseph Mikhael
Jeffrey Matous
David Vesole
Min Chen
Mohamed H Zaki
Christian Jacques
Zhinuan Yu
Kenneth C Anderson

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
Trageting the Multiple Myeloma EpigenomeP50CA100707 · NCI · DANA-FARBER CANCER INSTITUTE · PI ANDERSON, KENNETH C., MUNSHI, NIKHIL C. · 2003 to 2023
$45.0M
Targeting Genomic Instability and Evolution in MyelomaP01CA155258 · NCI · DANA-FARBER CANCER INST · PI Jill Corre · 2011 to 2026
$32.5M
NCI NIH HHS P01 CA155258NCI NIH HHS P30 CA016058NCI NIH HHS P50 CA100707
6 · The paper itself

Abstract

This multicenter, open-label, randomized phase 2 study assessed the efficacy and safety of pomalidomide (POM) with/without low-dose dexamethasone (LoDEX) in patients with relapsed/refractory multiple myeloma (RRMM). Patients who had received ≥2 prior therapies (including lenalidomide [LEN] and bortezomib [BORT]) and had progressed within 60 days of their last therapy were randomized to POM (4 mg/day on days 1-21 of each 28-day cycle) with/without LoDEX (40 mg/week). The primary end point was progression-free survival (PFS). In total, 221 patients (median 5 prior therapies, range 1-13) received POM+LoDEX (n = 113) or POM (n = 108). With a median follow-up of 14.2 months, median PFS was 4.2 and 2.7 months (hazard ratio = 0.68, P = .003), overall response rates (ORRs) were 33% and 18% (P = .013), median response duration was 8.3 and 10.7 months, and median overall survival (OS) was 16.5 and 13.6 months, respectively. Refractoriness to LEN, or resistance to both LEN and BORT, did not affect outcomes with POM+LoDEX (median PFS 3.8 months for both; ORRs 30% and 31%; and median OS 16 and 13.4 months). Grade 3-4 neutropenia occurred in 41% (POM+LoDEX) and 48% (POM); no grade 3-4 peripheral neuropathy was reported. POM+LoDEX was effective and generally well tolerated and provides an important new treatment option for RRMM patients who have received multiple prior therapies. This trial was registered at www.clinicaltrials.gov as #NCT00833833.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibDexamethasoneDisease-Free SurvivalDrug Resistance, NeoplasmFemaleHumansImmunologic FactorsLenalidomideMaleMiddle AgedMultiple MyelomaBoronic AcidsBortezomibDexamethasoneImmunologic FactorsLenalidomidepomalidomidePyrazinesThalidomide

Identifiers

PMID24421329
PMCPMC3962162

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.