Evidence map›Paper›PMID 37747623›Full record

ArticleTargeted oncology2023

Safety of Subcutaneous Daratumumab in Anti-CD38 Monoclonal Antibody-Naïve Patients with Plasma Cell Disorders: A Multicenter Real-Life Experience.

Danilo De Novellis, Raffaele Fontana, Salvatore Palmieri, Roberta Della Pepa, Maria Di Perna, Giusy Cetani, Daniela Esposito, Angela Amendola, Giuseppe Delle Cave, Bianca Serio and 23 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 19% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Observational
  3. 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

33 authors at 8 institutions in 1 country.

Danilo De NovellisDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Raffaele FontanaDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Salvatore PalmieriHematology, Hospital "Antonio Cardarelli", Naples, Italy.
Roberta Della PepaHematology, Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Maria Di PernaHematology, Hospital "Andrea Tortora", Pagani, Italy.
Giusy CetaniHematology, Hospital "Sant'Anna e San Sebastiano", Caserta, Italy.
Daniela EspositoHematology, Hospital "San Giuseppe Moscati", Aversa, Italy.
Angela AmendolaHematology and Transplant Center "San Carlo" Hospital, Potenza, Italy.
Giuseppe Delle CaveHematology, Hospital "San Giuliano", Giugliano, Italy.
Bianca SerioDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Denise MoriniDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Michela RizzoDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Laura MettivierDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Fabio TrastulliHematology, Hospital "Antonio Cardarelli", Naples, Italy.
Stefano RoccoHematology, Hospital "Antonio Cardarelli", Naples, Italy.
Anastasia PaganoHematology, Hospital "Andrea Tortora", Pagani, Italy.
Serafina BarbatoHematology, Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Aldo LeoneHematology, Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Martina La MagnaHematology, Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Rosario BiancoHematology, Hospital "Sant'Anna e San Sebastiano", Caserta, Italy.
Gabriella RascatoHematology, Hospital "San Giuseppe Moscati", Aversa, Italy.
Angela CarobeneHematology and Transplant Center "San Carlo" Hospital, Potenza, Italy.
Bianca CuffaDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy.
Marialuigia IannalfoHematology, Hospital "San Giuliano", Giugliano, Italy.
Valentina GiudiceDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy. vgiudice@unisa.it.ORCID 0000-0002-7492-6848
Gino SvaneraHematology, Hospital "San Giuliano", Giugliano, Italy.
Mario AnnunziataHematology, Hospital "San Giuseppe Moscati", Aversa, Italy.
Michele PizzutiHematology and Transplant Center "San Carlo" Hospital, Potenza, Italy.
Ferdinando FrigeriHematology, Hospital "Sant'Anna e San Sebastiano", Caserta, Italy.
Catello CalifanoHematology, Hospital "Andrea Tortora", Pagani, Italy.
Felicetto FerraraHematology, Hospital "Antonio Cardarelli", Naples, Italy.
Fabrizio PaneHematology, Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Carmine SelleriDepartment of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, 84081, Baronissi, Italy. cselleri@unisa.it.
University of Salerno · ITUniversity of Naples Federico II · ITOspedale Antonio Cardarelli · ITAzienda Ospedaliera S.Giuseppe Moscati · ITCTO Andrea Alesini · ITGiuliani (Italy) · ITOspedale San Carlo · ITOspedale Sant'Anna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDaratumumab, an anti-CD38 monoclonal antibody, is used for treatment of multiple myeloma (MM) and light chain amyloidosis at an intravenous dosage of 16 mg/kg or at a subcutaneous fixed dose of 1800 mg. However, the subcutaneous formulation has only recently been approved in Europe, and real-life data on its safety are still few.

objectiveIn this multicenter retrospective real-life experience, we provided evidence for the safety of subcutaneous daratumumab in plasma cell disorders. PATIENTS AND

methodsA total of 189 patients diagnosed with MM or light chain amyloidosis were included in this retrospective study, and all subjects were daratumumab-naïve. Primary endpoint was safety of subcutaneous daratumumab, especially for infusion-related reaction (IRR) incidence and severity. All patients received premedication with dexamethasone, paracetamol, and antihistamine, with montelukast usage in 85% of cases.

resultsEight patients (4%) experienced IRRs, mainly of grade I-II, and other frequent toxicities were: hematological (thrombocytopenia, 4%; neutropenia, 5%; lymphopenia, 6%) and non-hematological (pneumonia, 4%; diarrhea, 2%; and cytomegalovirus reactivation, 0.5%). In our multicenter retrospective real-life experience, subcutaneous daratumumab was well-tolerated with an excellent safety profile with a very low (4%) IRR incidence, even in frailer MM patients with severe renal impairment or increased body weight.

conclusionsSubcutaneous daratumumab was safe in a real-life setting including patients with severe renal failure and advanced disease. However, further studies on larger and prospective cohorts are required to confirm our real-life observations.

Indexed as

AmyloidosisAntineoplastic AgentsMultiple MyelomaAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansPlasma CellsProspective StudiesRetrospective StudiesAntibodies, MonoclonalAntineoplastic Agentsdaratumumab

Identifiers

PMID37747623
PMCPMC10663178
OpenAlexW4387002785

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.