Evidence map›Paper›PMID 32083996›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Bendamustine With Dexamethasone in Relapsed/Refractory Systemic Light-Chain Amyloidosis: Results of a Phase II Study.

Suzanne Lentzsch, Galina G Lagos, Raymond L Comenzo, Jeffrey A Zonder, Keren Osman, Samuel Pan, Divaya Bhutani, Silva Pregja, Vaishali Sanchorawala, Heather Landau

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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
2.6field-weighted citation impact, top 10% 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.

NCT01222260 phase2completednot on this map

Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis

TypeinterventionalSponsorColumbia UniversityRan2013 to 2019Enrolled40ConditionsAL AmyloidosisArmsBendamustine, Dexamethasone
NCT04943302 phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

TypeinterventionalSponsorTufts Medical CenterRan2022 to 2026Enrolled0ConditionsAmyloidosis, Light Chain (AL) AmyloidosisArmsBendamustine Hydrochloride, Isatuximab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. A Focus on Waldenström Macroglobulinemia and AL Amyloidosis.Journal of the advanced practitioner in oncology · 2022
    Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Management of AL amyloidosis in 2020.Hematology. American Society of Hematology. Education Program · 2020
    Article
  18. Review
  19. Review
  20. 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

10 authors at 5 institutions in 1 country.

Suzanne LentzschDivision of Hematology/Oncology, Columbia University Medical Center, New York, NY.
Galina G LagosDivision of Hematology/Oncology, Columbia University Medical Center, New York, NY.
Raymond L ComenzoDivision of Hematology/Oncology, Tufts Medical Center, Boston, MA.
Jeffrey A ZonderBarbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
Keren OsmanTisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.
Samuel PanDivision of Hematology/Oncology, Columbia University Medical Center, New York, NY.
Divaya BhutaniDivision of Hematology/Oncology, Columbia University Medical Center, New York, NY.
Silva PregjaBarbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI.
Vaishali SanchorawalaAmyloidosis Center, Boston University School of Medicine and Boston Medical Center, Boston, MA.
Heather LandauDivision of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
Columbia University Irving Medical Center · USWayne State University · USIcahn School of Medicine at Mount Sinai · USMemorial Sloan Kettering Cancer Center · USTufts Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Tumor Biology and Microenvironment ProgramP30CA013696 · NCI · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI Anil K Rustgi · 1985 to 2026
$115.3M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA013696
6 · The paper itself

Abstract

purposeNo established treatments exist for relapsed/refractory systemic light-chain (AL) amyloidosis. Bendamustine has shown potential in the treatment of multiple myeloma. We conducted a phase II, multicenter trial to assess the efficacy and safety of bendamustine with dexamethasone (ben-dex) in patients with persistent or progressive AL amyloidosis after ≥ 1 prior therapy.

methodsThe trial enrolled 31 patients who received bendamustine on days 1 and 2 (100 mg/m

resultsPatients received a median of 4 cycles (range, 2-12 cycles) with 57% of patients achieving a PR or better (11% complete response, 18% very good PR). The overall organ response was 29% among the 24 patients who had measurable organ involvement. Treatment was well tolerated with no grade 5 treatment-related adverse events (AEs). Sixty-five percent of patients had a therapy-related grade 3-4 AE. The most common AEs included myelosuppression, fatigue, and nausea/vomiting. The median overall survival was 18.2 months (95% CI, 11.3 to 43.8 months), and hematologic response was associated with prolonged survival (

conclusionOverall, ben-dex is a viable treatment option with substantial efficacy and limited toxicity for patients with pretreated AL amyloidosis who have limited therapeutic options. This trial was registered at (ClinicalTrials.gov identifier: NCT01222260).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDexamethasoneDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleHumansImmunoglobulin Light-chain AmyloidosisKaplan-Meier EstimateMaleMiddle AgedNauseaNeoplasm Recurrence, LocalBendamustine HydrochlorideDexamethasone

Identifiers

PMID32083996
PMCPMC7193746
OpenAlexW3007009425

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.