Evidence map›Paper›PMID 33947178›Full record

ArticleTurkish journal of haematology : official journal of Turkish Society of Haematology2021

Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients

Sinan Mersin, Ayfer Gedük, Özgür Mehtap, Pınar Tarkun, Serkan Ünal, Merve Gökçen Polat, Kemal Aygün, Emel Merve Yenihayat, Hayrunnisa Albayrak, Abdullah Hacıhanifioğlu

Registry-linked trialAbstract read
In one paragraph

Article in Turkish journal of haematology : official journal of Turkish Society of Haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06284395 (Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT06284395 recruitingnot on this mapstarted 2023, after this paper: background citation

Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study

TypeobservationalSponsorHospital General de MexicoRan2023 to 2024Enrolled83ConditionsResponse, Acute Phase, SurvivorshipArmsBortezomib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Sinan MersinKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0001-7588-6000
Ayfer GedükKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0001-9556-8915
Özgür MehtapKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0002-5603-1178
Pınar TarkunKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0003-0851-3583
Serkan ÜnalKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0002-8513-8476
Merve Gökçen PolatKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0001-9797-3922
Kemal AygünKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0001-6033-5150
Emel Merve YenihayatKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0002-2422-8646
Hayrunnisa AlbayrakKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0003-4160-1139
Abdullah HacıhanifioğluKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyORCID 0000-0001-5164-6301

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Constantly increasing health expenditures lead to the use of generic molecules and generic versions of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects, and reliability of generic bortezomib in newly diagnosed multiple myeloma (MM) patients. Materials and Methods: The data of 95 patients who received four cycles of bortezomib as first- or second-line therapy in a single center were retrospectively recorded. Treatment responses, side effects, and progression-free survival (PFS) rates were calculated and compared. Results: Of the 95 patients, 42 used the original and 53 used the generic molecule. Epidemiological data, MM types, genetic risk groups, laboratory values at diagnosis, and bortezomib treatment lines (as a first line or second) were evaluated and there was no statistical difference between the two groups. When the response rates were evaluated according to International Myeloma Working Group criteria, there was no significant difference (p=0.42). Rates of partial response and higher responses were similar (81% vs. 79.2%, p=0.84). PFS rates were 42.8 months with the original and 37.8 months with the generic molecule (p=0.68). Side effects were seen in 44.2% of all patients, and the most common side effects were neuropathy, cytopenia, and infection. These rates were similar in the two groups (p=0.55). Conclusion: Although this retrospective study is limited in scope, it is the first study comparing the original molecule of bortezomib with a generic version. There were no statistical differences between the two groups in terms of treatment responses, PFS, or side effects. However, large-scale evaluations will help obtain more data on this subject.

Indexed as

Antineoplastic AgentsMultiple MyelomaAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneHumansReproducibility of ResultsRetrospective StudiesTreatment OutcomeAntineoplastic AgentsBortezomibDexamethasoneBortezomibEquivalentMultiple myeloma

Identifiers

PMID33947178
PMCPMC8386308

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Registered trials

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.