Evidence map›Paper›PMID 25840597›Full record

Trial reportHaematologica2015

Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: an interim analysis from the prospective GMMG-MM5 trial.

Maximilian Merz, Hans Salwender, Mathias Haenel, Elias K Mai, Uta Bertsch, Christina Kunz, Thomas Hielscher, Igor W Blau, Christof Scheid, Dirk Hose and 13 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 6 pooled it
5.7field-weighted citation impact, top 4% 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

42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 71 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

23 authors at 14 institutions in 1 country.

Maximilian MerzUniversity Hospital, Heidelberg; Germany.
Hans SalwenderAsklepios Hospital Hamburg Altona; Germany.
Mathias HaenelKlinikum Chemnitz; Germany.
Elias K MaiUniversity Hospital, Heidelberg; Germany.
Uta BertschUniversity Hospital, Heidelberg; Germany National Center for Tumor Diseases, Heidelberg; Germany.
Christina KunzGerman Cancer Research Center, Heidelberg; Germany.
Thomas HielscherGerman Cancer Research Center, Heidelberg; Germany.
Igor W BlauCharité Universitätsmedizin, Berlin; Germany.
Christof ScheidUniversity Hospital, Köln; Germany.
Dirk HoseUniversity Hospital, Heidelberg; Germany.
Anja SeckingerUniversity Hospital, Heidelberg; Germany.
Anna JauchUniversity Hospital, Heidelberg; Germany.
Jens HillengassUniversity Hospital, Heidelberg; Germany.
Marc S RaabUniversity Hospital, Heidelberg; Germany.
Baerbel SchurichUniversity Hospital, Heidelberg; Germany.
Markus MunderUniversity Medical Center, Mainz; Germany.
Ingo G H Schmidt-WolfUniversity Hospital, Bonn; Germany.
Christian GereckeHelios Hospital, Berlin Buch; Germany.
Hans-Walter LindemannKath. Krankenhaus, Hagen; Germany.
Matthias ZeisAsklepios Hospital St. Georg, Hamburg; Germany.
Katja WeiselUniversity Hospital, Tübingen; Germany.
Jan DuerigUniversity Hospital Essen, Germany.
Hartmut GoldschmidtUniversity Hospital, Heidelberg; Germany National Center for Tumor Diseases, Heidelberg; Germany hartmut.goldschmidt@med.uni-heidelberg.de.
Heidelberg University · DEUniversity Hospital Heidelberg · DEAsklepios Klinik Altona · DEAsklepios Klinik St. Georg · DECharité - Universitätsmedizin Berlin · DEEssen University Hospital · DEGerman Cancer Research Center · DEHelios Hospital Berlin-Buch · DEKlinikum Chemnitz · DESt. Josef Krankenhaus · DEUniversity Children's Hospital Tübingen · DEUniversity Hospital Bonn · DEUniversity Hospital Cologne · DEUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We investigated the impact of subcutaneous versus intravenous bortezomib in the MM5 trial of the German-Speaking Myeloma Multicenter Group which compared bortezomib, doxorubicin, and dexamethasone with bortezomib, cyclophosphamide, and dexamethasone induction therapy in newly diagnosed multiple myeloma. Based on data from relapsed myeloma, the route of administration for bortezomib was changed from intravenous to subcutaneous after 314 of 604 patients had been enrolled. We analyzed 598 patients who received at least one dose of trial medication. Adverse events were reported more frequently in patients treated with intravenous bortezomib (intravenous=65%; subcutaneous=56%, P=0.02). Rates of grade 2 or more peripheral neuropathy were higher in patients treated with intravenous bortezomib during the third cycle (intravenous=8%; subcutaneous=2%, P=0.001). Overall response rates were similar in patients treated intravenously or subcutaneously. The presence of International Staging System stage III disease, renal impairment or adverse cytogenetic abnormalities did not have a negative impact on overall response rates in either group. To our knowledge this is the largest study to present data comparing subcutaneous with intravenous bortezomib in newly diagnosed myeloma. We show better tolerance and similar overall response rates for subcutaneous compared to intravenous bortezomib. The clinical trial is registered at eudract.ema.europa.eu as n. 2010-019173-16.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAdultAgedAntineoplastic AgentsBortezomibCyclophosphamideDexamethasoneDoxorubicinDrug Administration ScheduleFemaleHumansInduction ChemotherapyInjections, IntravenousInjections, SubcutaneousKidneyMaleAntineoplastic AgentsBortezomibCyclophosphamideDexamethasoneDoxorubicin

Identifiers

PMID25840597
PMCPMC4486231
OpenAlexW2166059514

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.