Evidence map›Paper›PMID 20385792›Full record

Trial reportBlood2010

Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma.

Paul G Richardson, Edie Weller, Sagar Lonial, Andrzej J Jakubowiak, Sundar Jagannath, Noopur S Raje, David E Avigan, Wanling Xie, Irene M Ghobrial, Robert L Schlossman and 15 more

5 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 360 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
360citing papers in PubMed, 6 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.

NCT00378105 phase1 / phase2active not recruitingnot on this map

An Open-Label Phase I/II Study of the Safety and Efficacy of Bortezomib, Lenalidomide and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2006 to 2026Enrolled68ConditionsMultiple MyelomaArmsBortezomib, Lenalidomide, dexamethasone
NCT01647165 phase2withdrawnnot on this mapstarted 2012, after this paper: background citation

Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2015Enrolled0ConditionsMultiple MyelomaArmsBortezomib, Lenalidomide, Dexamethasone
NCT02103335 phase1completednot on this mapstarted 2014, after this paper: background citation

A Phase 1, Multicenter, Open-label, Dose-Escalation Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorCelgeneRan2014 to 2016Enrolled38ConditionsMultiple Myeloma in Relapse, Refractory Multiple Myeloma, Multiple MyelomaArmspomalidomide, marizomib, low-dose dexamethasone
NCT03992170 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow

TypeinterventionalSponsorAzienda Ospedaliera Universitaria SeneseRan2018 to 2022Enrolled50ConditionsMyeloma MultipleArmsDaratumumab
NCT04009109 phase2active not recruitingnot on this mapstarted 2020, after this paper: background citation

A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

TypeinterventionalSponsorAlliance Foundation Trials, LLC.Ran2020 to 2027Enrolled79ConditionsMyeloma, MultipleArmsLenalidomide, Ixazomib, Daratumumab Injection, Dexamethasone
3 · Its place in the literature

Who cites it

360 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  6. Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017
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300 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

25 authors.

Paul G RichardsonDana-Farber Cancer Institute, Boston, MA 02115, USA. paul_richardson@dfci.harvard.edu
Edie Weller
Sagar Lonial
Andrzej J Jakubowiak
Sundar Jagannath
Noopur S Raje
David E Avigan
Wanling Xie
Irene M Ghobrial
Robert L Schlossman
Amitabha Mazumder
Nikhil C Munshi
David H Vesole
Robin Joyce
Jonathan L Kaufman
Deborah Doss
Diane L Warren
Laura E Lunde
Sarah Kaster
Carol Delaney
Teru Hideshima
Constantine S Mitsiades
Robert Knight
Dixie-Lee Esseltine
Kenneth C Anderson

Funding

Trageting the Multiple Myeloma EpigenomeP50CA100707 · NCI · DANA-FARBER CANCER INSTITUTE · PI MUNSHI, NIKHIL C. · 2003 to 2023
$45.0M
Targeting Myeloma Cell-Host Bone Marrow InteractionsP01CA078378 · NCI · DANA-FARBER CANCER INSTITUTE · PI ANDERSON, KENNETH C. · 1998 to 2014
$26.2M
NCI NIH HHS P01 CA078378NCI NIH HHS P50 CA100707
6 · The paper itself

Abstract

This phase 1/2 study is the first prospective evaluation of lenalidomide-bortezomib-dexamethasone in front-line myeloma. Patients (N = 66) received 3-week cycles (n = 8) of bortezomib 1.0 or 1.3 mg/m(2) (days 1, 4, 8, 11), lenalidomide 15 to 25 mg (days 1-14), and dexamethasone 40 or 20 mg (days 1, 2, 4, 5, 8, 9, 11, 12). Responding patients proceeded to maintenance or transplantation. Phase 2 dosing was determined to be bortezomib 1.3 mg/m(2), lenalidomide 25 mg, and dexamethasone 20 mg. Most common toxicities included sensory neuropathy (80%) and fatigue (64%), with only 27%/2% and 32%/3% grade 2/3, respectively. In addition, 32% reported neuropathic pain (11%/3%, grade 2/3). Grade 3/4 hematologic toxicities included lymphopenia (14%), neutropenia (9%), and thrombocytopenia (6%). Thrombosis was rare (6% overall), and no treatment-related mortality was observed. Rate of partial response was 100% in both the phase 2 population and overall, with 74% and 67% each achieving very good partial response or better. Twenty-eight patients (42%) proceeded to undergo transplantation. With median follow-up of 21 months, estimated 18-month progression-free and overall survival for the combination treatment with/without transplantation were 75% and 97%, respectively. Lenalidomide-bortezomib-dexamethasone demonstrates favorable tolerability and is highly effective in the treatment of newly diagnosed myeloma. This study is registered at http://clinicaltrials.gov as NCT00378105.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCombined Modality TherapyDexamethasoneFatigueHematologic DiseasesHumansLenalidomideMultiple MyelomaPainPyrazinesRemission InductionSensation DisordersStem Cell TransplantationSurvival AnalysisBoronic AcidsBortezomibDexamethasoneLenalidomidePyrazinesThalidomide

Identifiers

PMID20385792
PMCPMC3324254

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.