Evidence map›Paper›PMID 21596852›Full record

Trial reportBlood2011

Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial.

Andrzej J Jakubowiak, Kent A Griffith, Donna E Reece, Craig C Hofmeister, Sagar Lonial, Todd M Zimmerman, Erica L Campagnaro, Robert L Schlossman, Jacob P Laubach, Noopur S Raje and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00724568 (A Multi-Institutional Phase I/II Study of Revlimid®), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 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.

NCT00724568 phase1 / phase2completednot on this map

A Multi-Institutional Phase I/II Study of Revlimid® (Lenalidomide), Velcade® (Bortezomib), Dexamethasone, and Doxil®, (RVDD) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2008 to 2014Enrolled74ConditionsMultiple MyelomaArmsLenalidomide, Bortezomib, Dexamethasone, Doxil
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  19. Multiple myeloma in the marrow: pathogenesis and treatments.Annals of the New York Academy of Sciences · 2016
    Review
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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

21 authors.

Andrzej J JakubowiakUniversity of Michigan, Ann Arbor, MI 48109-5936, USA. ajakubow@umich.edu
Kent A Griffith
Donna E Reece
Craig C Hofmeister
Sagar Lonial
Todd M Zimmerman
Erica L Campagnaro
Robert L Schlossman
Jacob P Laubach
Noopur S Raje
Tara Anderson
Melissa A Mietzel
Colleen K Harvey
Sandra M Wear
Jennifer C Barrickman
Craig L Tendler
Dixie-Lee Esseltine
Susan L Kelley
Mark S Kaminski
Kenneth C Anderson
Paul G Richardson

Funding

Translational Training Grant in Experimental TherapeuticsK12CA133250 · NCI · OHIO STATE UNIVERSITY · PI WILLIAM E. CARSON, Rosa Lapalombella · 2008 to 2026
$15.0M
NCI NIH HHS K12 CA133250NCI NIH HHS K12CA133250
6 · The paper itself

Abstract

This phase 1/2 trial evaluated combination lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (RVDD) in newly diagnosed multiple myeloma (MM) patients. Patients received RVDD at 4 dose levels, including the maximum tolerated dose (MTD). Patients with a very good partial response or better (≥ VGPR) after cycle 4 proceeded to autologous stem cell transplantation or continued treatment. The primary objectives were MTD evaluation and response to RVDD after 4 and 8 cycles. Seventy-two patients received a median of 4.5 cycles. The MTDs were lenalidomide 25 mg, bortezomib 1.3 mg/m(2), pegylated liposomal doxorubicin 30 mg/m(2), and dexamethasone 20/10 mg, as established with 3-week cycles. The most common adverse events were fatigue, constipation, sensory neuropathy, and infection; there was no treatment-related mortality. Response rates after 4 and 8 cycles were 96% and 95% partial response or better, 57% and 65% ≥ VGPR, and 29% and 35% complete or near-complete response, respectively. After a median follow-up of 15.5 months, median progression-free survival (PFS) and overall survival (OS) were not reached. The estimated 18-month PFS and OS were 80.8% and 98.6%, respectively. RVDD was generally well tolerated and highly active, warranting further study in newly diagnosed MM patients. This trial was registered at www.clinicaltrials.gov as NCT00724568.

Indexed as

AdultAgedAntibiotics, AntineoplasticAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibDexamethasoneDisease-Free SurvivalDoxorubicinFemaleFollow-Up StudiesHumansLenalidomideMaleMiddle AgedAntibiotics, AntineoplasticAntineoplastic Agents, HormonalBoronic AcidsBortezomibDexamethasoneDoxorubicinLenalidomidePyrazinesThalidomide

Identifiers

PMID21596852
PMCPMC3142898

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.