Evidence map›Paper›PMID 31623097›Full record

ArticleJournal of clinical medicine2019

Clinical Benefit of Long-Term Disease Control with Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients.

Marina Silvia Parisi, Salvatore Leotta, Alessandra Romano, Vittorio Del Fabro, Enrica Antonia Martino, Valeria Calafiore, Rachele Giubbolini, Uros Markovic, Valerio Leotta, Mary Ann Di Giorgio and 3 more

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 20% 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, 14 citations in OpenAlex.

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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

13 authors at 2 institutions in 1 country.

Marina Silvia ParisiDivision of Hematology, AOU "Policlinico - Vittorio Emanuele", Via Santa Sofia 78, 95124 Catania, Italy. marinaparisi@hotmail.it.
Salvatore LeottaDivision of Hematology, AOU "Policlinico - Vittorio Emanuele", Via Santa Sofia 78, 95124 Catania, Italy. leotta3@yahoo.it.
Alessandra RomanoDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. sandrina.romano@gmail.com.ORCID 0000-0002-6333-4433
Vittorio Del FabroDivision of Hematology, AOU "Policlinico - Vittorio Emanuele", Via Santa Sofia 78, 95124 Catania, Italy. vdelfabro@yahoo.it.
Enrica Antonia MartinoDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. enricaantoniamartino@libero.it.
Valeria CalafioreDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. valeriacalaf@gmail.com.
Rachele GiubboliniDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. r.giubbolini10@gmail.com.
Uros MarkovicDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. urosmarkovic09041989@gmail.com.ORCID 0000-0003-0868-5676
Valerio LeottaDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. valerio_leotta@yahoo.it.
Mary Ann Di GiorgioDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. maryanndg@live.it.
Daniele TibulloDepartment of Biomedical and Biotechnological Science, University of Catania, 95124 Catania, Italy. d.tibullo@unict.it.
Francesco Di RaimondoDepartment of General Surgery and Medical-Surgical Specialties, Haematology Section, University of Catania, Via Santa Sofia 78, 95124 Catania, Italy. diraimon@gmail.com.
Concetta ConticelloDivision of Hematology, AOU "Policlinico - Vittorio Emanuele", Via Santa Sofia 78, 95124 Catania, Italy. ettaconticello@gmail.com.
University of Catania · ITAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe retrospectively analysed relapsed/refractory MM (RRMM) patients treated with pomalidomide and dexamethasone (PomaD) either in real life, or previously enrolled in an interventional (STRATUS, MM-010) or currently enrolled in an observational study (MM-015) to provide further insights on safety and tolerability and clinical efficacy.

methodsBetween July 2013 and July 2018, 76 RRMM patients (including 33 double refractory MM) received pomalidomide 4 mg daily given orally on days 1-21 of each 28-day cycle, and dexamethasone 40 mg weekly (≤75 years) or 20 mg weekly for patients aged > 75 years. In nine patients a third agent was added to increase the response: Cyclophosphamide (in two fit patients) or clarithromycin (in seven frail patients). Patients received subcutaneous filgrastim as part of the prophylaxis regimen for neutropenia.

resultsA median number of six (range 2-21) PomaD cycles were given. The regimen was well tolerated with grade 3-4 haematological and non-haematological adverse events in 39 (51%) and 25 (33%) patients, respectively. In patients who developed serious AE, pomalidomide dose reduction (11%, 14%) or definitive discontinuation (18%, 23%) were applied. All patients have been evaluated for response within the first two cycles. The disease control rate (DCR), i.e., those patients that had a response equal or better than stable disease (≥ SD), was high (89%), with 44% overall response rate (ORR) after six cycles. The achieved best responses were complete remission (CR, 5%), very good partial remission (VGPR, 4%), partial remission (PR, 35%), minimal response (MR, 7%), and stable disease (SD, 38%). After a median follow up of 19.6 months, median progression free survival was 9.4 months, and overall survival (OS) was 19.02 months. Univariate analysis showed that double refractory patients, or who received more than three previous lines had shorter PFS. At 18 months, regardless of the depth of response, patients with a disease control of at least six months, defined as maintenance of a best clinical and/or biochemical response to treatment for almost six months, had prolonged PFS (35.3% versus 20.6%,

Indexed as

double refractorymultiple myelomapomalidomide

Identifiers

PMID31623097
PMCPMC6832641
OpenAlexW2980778150

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.