Evidence map›Paper›PMID 28522573›Full record

Trial reportHaematologica2017

Lenalidomide/melphalan/dexamethasone in newly diagnosed patients with immunoglobulin light chain amyloidosis: results of a prospective phase 2 study with long-term follow up.

Ute Hegenbart, Tilmann Bochtler, Axel Benner, Natalia Becker, Christoph Kimmich, Arnt V Kristen, Jörg Beimler, Ernst Hund, Markus Zorn, Anja Freiberger and 6 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Haematologica, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Updates in the Diagnosis and Management of AL Amyloidosis.Current hematologic malignancy reports · 2020
    Review
  10. A novel risk score to predict survival in advanced heart failure due to cardiac amyloidosis.Clinical research in cardiology : official journal of the German Cardiac Society · 2020
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Novel Therapies in Light Chain Amyloidosis.Kidney international reports · 2018
    Review
  18. Light Chain Amyloidosis.Mediterranean journal of hematology and infectious diseases · 2018
    Review
  19. Review
  20. AL amyloidosis: from molecular mechanisms to targeted therapies.Hematology. American Society of Hematology. Education Program · 2017
    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

16 authors at 2 institutions in 1 country.

Ute HegenbartDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany ute.hegenbart@med.uni-heidelberg.de.
Tilmann BochtlerDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Axel BennerDivision of Biostatistics, German Cancer Research Center, Heidelberg, Germany.
Natalia BeckerDivision of Biostatistics, German Cancer Research Center, Heidelberg, Germany.
Christoph KimmichDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Arnt V KristenDivision of Cardiology, University of Heidelberg, Germany.
Jörg BeimlerDivision of Nephrology, University of Heidelberg, Germany.
Ernst HundDepartment of Neurology, University of Heidelberg, Germany.
Markus ZornDivision of Clinical Chemistry, University of Heidelberg, Germany.
Anja FreibergerCoordination Center for Clinical Trials, KKS, Heidelberg, Germany.
Marianne GawlikDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Hartmut GoldschmidtDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Dirk HoseDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Anna JauchInstitute of Human Genetics, University Heidelberg, Germany.
Anthony D HoDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Stefan O SchönlandDepartment of Internal Medicine, Division of Hematology/Oncology, University of Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chemotherapy in light chain amyloidosis aims to normalize the involved free light chain in serum, which leads to an improvement, or at least stabilization of organ function in most responding patients. We performed a prospective single center phase 2 trial with 50 untreated patients not eligible for high-dose treatment. The treatment schedule comprised 6 cycles of oral lenalidomide, melphalan and dexamethasone every 4 weeks. After 6 months, complete remission was achieved in 9 patients (18%), very good partial remission in 16 (32%) and partial response in 9 (18%). Overall, organ response was observed in 24 patients (48%). Hematologic and cardiac toxicities were predominant adverse events. Mortality at 3 months was low at 4% (n=2) despite the inclusion of 36% of patients (n=18) with cardiac stage Mayo 3. After a median follow-up of 50 months, median overall and event-free survival were 67.5 months and 25.1 months, respectively. We conclude that the treatment of lenalidomide, melphalan and dexamethasone is very effective in achieving a hematologic remission, organ response and, consecutively, a long survival in transplant ineligible patients with light chain amyloidosis. However, as toxicity and tolerability are the major problems of a 3-drug regimen, a strict surveillance program is necessary and sufficient to avoid severe toxicities.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFollow-Up StudiesHumansImmunoglobulin Light-chain AmyloidosisLenalidomideMaleMelphalanMiddle AgedRemission InductionSurvival AnalysisThalidomideDexamethasoneLenalidomideMelphalanThalidomide

Identifiers

PMID28522573
PMCPMC5541875
OpenAlexW2615835142

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.