Evidence map›Paper›PMID 33050272›Full record

ArticleJournal of clinical medicine2020

Daratumumab Monotherapy in Severe Patients with AL Amyloidosis and Biopsy-Proven Renal Involvement: A Real Life Experience.

Dario Roccatello, Roberta Fenoglio, Carla Naretto, Simone Baldovino, Savino Sciascia, Michela Ferro, Daniela Rossi

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 34% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
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  4. 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

7 authors at 1 institution in 1 country.

Dario RoccatelloCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.
Roberta FenoglioCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.
Carla NarettoCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.
Simone BaldovinoCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.ORCID 0000-0002-4475-4117
Savino SciasciaCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.ORCID 0000-0003-1266-9441
Michela FerroCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.
Daniela RossiCMID-Nephrology and Dialysis Unit (ERK-net Member)-Center of Research of Nephrology, Rheumatology, and Rare Diseases, Interregional Coordinating Center of the Network of Rare Diseases, G. Bosco Hospital and University of Turin, 10152 Turin, Italy.
Ospedale San Giovanni Bosco · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis paper aims to describe the clinical experience with Daratumumab (DARA), a first-in-class anti-CD38 human monoclonal IgG1κ antibody monotherapy, in severe patients with AL and biopsy-proven renal involvement. Immunoglobulin light chain (AL) amyloidosis with multi-organ involvement is characterized by short survival. Novel powerful drugs are expanding the therapeutic options. Current treatment of AL amyloidosis, which has been adopted from multiple myeloma (MM), is based on chemotherapy targeting the underlying plasma cell clone. DARA is effective in treating MM. The clinical activity and toxicity profile of DARA as a single agent in the treatment of AL amyloidosis is currently under evaluation. PATIENTS AND

methodsDARA was administered in a series of patients with severe AL amyloidosis and biopsy-proven renal involvement. Five patients(mean age 64.2 years) were treated. One patient was refractory and one intolerant to conventional bortezomib-based therapy, two were treated with DARA for relapsing disease, and one was treated front-line.

resultsData showed that DARA monotherapy resulted in good clinical results, with the disappearance of M-proteins in four out of five patients and with serum free light chains (sFLC) ratio normalization in three out of four and a remarkable amelioration in the remaining patient. The four patients with still preserved renal function at baseline also showed serum creatinine stabilization or improvement and a decrease in proteinuria. These data were paralleled by the reduction of the N-terminal prohormone of brain natriuretic peptide (NT pro-BNP)values.

conclusionsOur data show that monotherapy with DARA had significant clinical efficacy in pretreated/naïve patients with severe AL amyloidosis and biopsy-proven renal involvement.

Indexed as

amyloidosisdaratumumablight chain

Identifiers

PMID33050272
PMCPMC7600836
OpenAlexW3092175242

What OpenQuestion holds

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Registered trials

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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.