Evidence map›Paper›PMID 29696194›Full record

ArticleContemporary clinical trials communications2017

Rationale and design of DUAL study: Doxycycline to Upgrade response in light chain (AL) amyloidosis (DUAL): A phase 2 pilot study of a two-pronged approach of prolonged doxycycline with plasma cell-directed therapy in the treatment of AL amyloidosis.

Anita D'Souza, Kathryn Flynn, Saurabh Chhabra, Binod Dhakal, Mehdi Hamadani, Kirsten Jacobsen, Marcelo Pasquini, Dorothee Weihrauch, Parameswaran Hari

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

10 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Paraproteinemia and neuropathy.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Review
  5. Review
  6. Article
  7. Cardiac amyloidosis: the need for early diagnosis.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2019
    Review
  8. Approach to a patient with cardiac amyloidosis.Journal of geriatric cardiology : JGC · 2019
    Article
  9. Novel Approaches for the Management of AL Amyloidosis.Current hematologic malignancy reports · 2018
    Review
  10. Baseline patient-reported outcomes in light-chain amyloidosis patients enrolled on an interventional clinical trial.Amyloid : the international journal of experimental and clinical investigation : the official journal of the International Society of Amyloidosis
    Article
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

9 authors at 2 institutions in 1 country.

Anita D'SouzaDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Kathryn FlynnFroedtert and Medical College of Wisconsin Cancer Center, Milwaukee, WI, United States.
Saurabh ChhabraDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Binod DhakalDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Mehdi HamadaniDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Kirsten JacobsenFroedtert and Medical College of Wisconsin Cancer Center, Milwaukee, WI, United States.
Marcelo PasquiniDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Dorothee WeihrauchDepartment of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI, United States.
Parameswaran HariDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI 53226, United States.
Froedtert Hospital · USMedical College of Wisconsin · US

Funding

Institutional Career Development CoreKL2TR001438 · NCATS · MEDICAL COLLEGE OF WISCONSIN · PI WIDLANSKY, MICHAEL E · 2015 to 2024
$2.9M
NCATS NIH HHS KL2 TR001438
6 · The paper itself

Abstract

Light chain (AL) amyloidosis is a plasma cell neoplasm associated with insoluble fibril deposition from clonal immunoglobulin chains systemically. The disease is associated with high early mortality and morbidity owing to advanced organ deposition as well as lack of proven de-fibrillogenic therapies. Pre-clinical and retrospective clinical data suggests that doxycycline has benefit in AL amyloidosis. The ongoing DUAL study is a single center, open label, phase 2 study in which patients with AL amyloidosis who are undergoing clone-directed therapy for the underlying neoplasm with oral doxycycline given for 1 year to test the hypothesis that prolonged doxycycline use will be safe, feasible, and lead to reduced early mortality in systemic AL amyloidosis and hasten organ amyloid response. Clinical follow up visits will occur at monthly intervals for systemic AL patients and at 3 monthly intervals for localized AL patients. Blood tests will be collected during these time points for hematologic response assessment. Organ testing will be conducted at 3 monthly intervals and radiologic testing will be conducted at 6 monthly intervals. Research blood samples will be collected at baseline, 6 and 12 months. Other correlative studies include matrix metalloproteinases (MMP), tissue inhibitor of metalloproteinases (TIMP) testing and patient-reported outcomes.

Indexed as

AmyloidosisChemotherapyDoxycyclineLight chainPhase 2 clinical trial

Identifiers

PMID29696194
PMCPMC5898504
OpenAlexW2749035428

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.