Evidence map›Paper›PMID 33763359›Full record

ArticleFrontiers in oncology2021

Daratumumab as Single Agent in Relapsed/Refractory Myeloma Patients: A Retrospective Real-Life Survey.

Uros Markovic, Alessandra Romano, Vittorio Del Fabro, Claudia Bellofiore, Anna Bulla, Marina Silvia Parisi, Salvatore Leotta, Massimo Gentile, Clotilde Cangialosi, Iolanda Vincelli and 9 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Review
  5. Multiple Myeloma in 2023 Ways: From Trials to Real Life.Current oncology (Toronto, Ont.) · 2023
    Review
  6. Review
  7. Review
  8. 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

19 authors at 11 institutions in 1 country.

Uros MarkovicPostgraduate School of Hematology, University of Catania, Catania, Italy.
Alessandra RomanoPostgraduate School of Hematology, University of Catania, Catania, Italy.
Vittorio Del FabroDivision of Hematology, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Claudia BellofiorePostgraduate School of Hematology, University of Catania, Catania, Italy.
Anna BullaPostgraduate School of Hematology, University of Catania, Catania, Italy.
Marina Silvia ParisiDivision of Hematology, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Salvatore LeottaDivision of Hematology, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Massimo GentileUnit of Clinical Hematology, Cosenza Hospital, Cosenza, Italy.
Clotilde CangialosiUnitá Operativa Complessa Ematologia, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy.
Iolanda VincelliUnità Operativa Complessa di Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy.
Giuseppe MineoUnitá Operativa Semplice Dipartimentale Ematologia, Ospedale San Vincenzo, Taormina, Italy.
Marco RossiDepartment of Clinical and Experimental Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.
Massimo PoidomaniServizio di Immunoematologia e Medicina Trasfusionale, Ematologia ASP Ragusa, Ragusa, Italy.
Giuseppina UccelloUnità Operativa Complessa Ematologia, Garibaldi Nesima Hospital, Catania, Italy.
Cinzia MaugeriDivision of Hematology, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Donato ManninaDivision of Hematology, Papardo Hospital, Messina, Italy.
Vanessa InnaoDivision of Hematology, Department of Human Pathology in Adulthood and Childhood, Policlinico "G. Martino", University of Messina, Messina, Italy.
Francesco Di RaimondoPostgraduate School of Hematology, University of Catania, Catania, Italy.
Concetta ConticelloDivision of Hematology, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Azienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITUniversity of Catania · ITAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITAzienda Ospedaliera di Cosenza · ITAzienda Ospedaliera Ospedali Riuniti Papardo Piemonte · ITFondazione Vincenzo Pansadoro · ITMagna Graecia University · ITOspedale Garibaldi · ITOspedale Vincenzo Cervello · ITUniversity of Messina · ITUniversity of Ragusa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe anti-CD38 monoclonal antibody daratumumab is approved as a single agent for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who received at least three prior lines of therapy, including proteasome inhibitor and immunomodulatory agent. A retrospective multicentric study was designed to evaluate feasibility, tolerability, and efficacy of daratumumab in monotherapy in RRMM.

methodsThis study included 44 consecutive RRMM patients that underwent daratumumab monotherapy after a median number of four prior therapies (range 2-9). Patients were treated in seven Sicilian centers, as part of Sicilian Myeloma Network and three Calabrian centers outside of controlled clinical trials from August 2016 through July 2020.

resultsThe regimen was well tolerated with few grade 3-4 haematological and rare non-haematological adverse events, such as pneumonia. Definitive discontinuation was due to disease progression in 25 (57%) patients. Since three patients did not complete at least one full cycle, a total of 41 patients was evaluated for response. Overall response rate was 37%, and the disease control rate (stable disease or better) was high (73%). The best achieved responses within 6 months were very good partial remission or better (27%), partial remission (10%), minimal response (14%) and stable disease (22%). After a median follow up of 7.8 months, median progression free survival (PFS) was 7.2 months and overall survival (OS) 7.8 months. Univariate analysis showed that patients with PR or better after 6 months of therapy had longer median PFS and OS (respectively 29.5 vs 3.6 months, p=0.0001 and 30.6 vs 3.9 months p=0.0001), confirmed by multivariate analysis. Furthermore, standard cytogenetic risk and biochemical relapse type had prolonged median PFS, but not OS (respectively unreached vs 2.6, p=0.03 and 23.9 vs 6.2, p=0.05) in both univariate and multivariate analysis. Additionally, univariate analysis showed that patients treated with carfilzomib-lenalidomide-dexamethasone prior to daratumumab had significantly shorter PFS compared to pomalidomide-dexamethasone (3.4 months vs 9.3 months, p=0.03), that multivariate analysis failed to confirm.

conclusionsOur findings indicate that daratumumab as single agent is safe and well-tolerated regimen in real-life, associated to prolonged PFS and OS in responding patients. No new safety signals were identified.

Indexed as

daratumumabimmunotherapymultiple myelomarelapsed/refractorysalvage treatment

Identifiers

PMID33763359
PMCPMC7982826
OpenAlexW3134684035

What OpenQuestion holds

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LicenceCC BY
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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.