Evidence map›Paper›PMID 25202139›Full record

Trial reportBlood2014

Long-term follow-up from a phase 1/2 study of single-agent bortezomib in relapsed systemic AL amyloidosis.

Donna E Reece, Ute Hegenbart, Vaishali Sanchorawala, Giampaolo Merlini, Giovanni Palladini, Joan Bladé, Jean-Paul Fermand, Hani Hassoun, Leonard Heffner, Vishal Kukreti and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
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. It is linked to trial NCT00298766 (An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–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.

NCT00298766 phase1 / phase2completednot on this map

An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2005 to 2009Enrolled70ConditionsAmyloidosisArmsVELCADE
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Observational
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Novel Therapies in Light Chain Amyloidosis.Kidney international reports · 2018
    Review
  14. The Effect and Safety of Bortezomib in the Treatment of AL Amyloidosis: A Systematic Review and Meta-Analysis.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2018
    Article
  15. Light Chain Amyloidosis.Mediterranean journal of hematology and infectious diseases · 2018
    Review
  16. Review
  17. Article
  18. Review
  19. AL Amyloidosis: Unfolding a Complex Disease.Journal of the advanced practitioner in oncology
    Review
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

17 authors.

Donna E ReecePrincess Margaret Cancer Center, Toronto, ON, Canada;
Ute HegenbartAmyloidosis Center, University of Heidelberg, Heidelberg, Germany;
Vaishali SanchorawalaBoston University Medical Center, Boston, MA;
Giampaolo MerliniAmyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Department of Molecular Medicine, University of Pavia, Pavia, Italy;
Giovanni PalladiniAmyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Department of Molecular Medicine, University of Pavia, Pavia, Italy;
Joan BladéHematology Department, Institute of Hematology and Oncology, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clínic, University of Barcelona, Barcelona, Spain;
Jean-Paul FermandHôpital Saint Louis, Paris, France;
Hani HassounMemorial Sloan-Kettering Cancer Center, New York, NY;
Leonard HeffnerHematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA;
Vishal KukretiPrincess Margaret Cancer Center, Toronto, ON, Canada;
Robert A VescioCedars-Sinai Medical Center, Los Angeles, CA;
Lixia PeiJanssen Research and Development, LLC, Raritan, NJ;
Christopher EnnyJanssen Research and Development, LLC, Raritan, NJ;
Dixie-Lee EsseltineTakeda Pharmaceuticals International Co., Cambridge, MA;
Helgi van de VeldeJanssen Research and Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium;
Andrew CakanaJanssen Research and Development, High Wycombe, United Kingdom; and.
Raymond L ComenzoTufts Medical Center, Boston, MA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CAN2007 was a phase 1/2 study of once- and twice-weekly single-agent bortezomib in relapsed primary systemic amyloid light chain amyloidosis (AL) amyloidosis. Seventy patients were treated, including 18 and 34 patients at the maximum planned doses on the once- and twice-weekly schedules. This prespecified final analysis provides mature response and long-term outcomes data after 3-year additional follow-up since the last report. In the once-weekly 1.6 mg/m(2) and twice-weekly 1.3 mg/m(2) bortezomib groups, final hematologic response rates were 68.8% and 66.7%; 80% of patients in each group sustained their response for ≥1 year. One-year progression-free rates were 72.2% and 76.8%. Median overall survival (OS) was 62.1 months and not reached; 4-year OS rates were 75.0% and 63.0%. Low baseline difference in κ/λ free light-chain level was associated with higher hematologic complete response rates and longer OS. At data cutoff, 40 (57%) patients had received subsequent therapy, including 19 (27%) retreated with bortezomib, 11 (58%) of whom achieved complete or partial hematologic responses. Four patients received prolonged bortezomib for between 3.5 and 5.6 years, with no new safety concerns, highlighting the feasibility of long-term therapy. Single-agent bortezomib produced durable hematologic responses and promising long-term OS in relapsed AL amyloidosis. This trial was registered at www.clinicaltrials.gov as #NCT00298766.

Indexed as

AdultAgedAged, 80 and overAmyloidosisAntineoplastic AgentsBoronic AcidsBortezomibFemaleFollow-Up StudiesHumansImmunoglobulin Light-chain AmyloidosisMaleMiddle AgedPyrazinesRecurrenceSurvival AnalysisAntineoplastic AgentsBoronic AcidsBortezomibPyrazines

Identifiers

PMID25202139
PMCPMC4199951

What OpenQuestion holds

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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.