Evidence map›Paper›PMID 25787915›Full record

Trial reportLeukemia2015

Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma.

E K Mai, U Bertsch, J Dürig, C Kunz, M Haenel, I W Blau, M Munder, A Jauch, B Schurich, T Hielscher and 15 more

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed
12.2field-weighted citation impact, top 1% 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

63 citing papers in PubMed, 140 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

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

25 authors at 15 institutions in 1 country.

E K MaiDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
U BertschDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
J DürigDepartment of Hematology, University Hospital Essen, Essen, Germany.
C KunzDivision of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany.
M HaenelDepartment of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.
I W BlauMedical Clinic, Charité University Medicine Berlin, Berlin, Germany.
M MunderDepartment of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.
A JauchInstitute of Human Genetics, University of Heidelberg, Heidelberg, Germany.
B SchurichCoordination Centers for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany.
T HielscherDivision of Biostatistics, German Cancer Research Center (DKFZ) Heidelberg, Heidelberg, Germany.
M MerzDepartment of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
B Huegle-DoerrDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
A SeckingerDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
D HoseDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
J HillengassDepartment of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
M S RaabDepartment of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
K NebenDepartment of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.
H-W LindemannDepartment of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.
M ZeisDepartment of Hematology, Asklepios Hospital St. Georg Hamburg, Hamburg, Germany.
C GereckeDepartment of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.
I G H Schmidt-WolfCenter for Integrated Oncology, University Hospital Bonn, Bonn, Germany.
K WeiselDepartment of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.
C ScheidDepartment of Internal Medicine I, University Hospital Köln, Köln, Germany.
H SalwenderDepartment of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.
H GoldschmidtDepartment of Internal Medicine V, University Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg on behalf of the German-Speaking Myeloma Multicenter Group (GMMG), Heidelberg, Germany.
Heidelberg University · DEUniversity Hospital Heidelberg · DEGerman Cancer Research Center · DEAsklepios Klinik Altona · DEAsklepios Klinik St. Georg · DECharité - Universitätsmedizin Berlin · DEEssen University Hospital · DEHelios Hospital Berlin-Buch · DEJohannes Gutenberg University Mainz · DEKatholisches Krankenhaus St. Johann Nepomuk · DEKlinikum Chemnitz · DENational Center for Tumor Diseases · DEUniversity Children's Hospital Tübingen · DEUniversity Hospital Bonn · DEUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3°) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (⩾2°) were higher in the PAd group (14.9 versus 8.4%, P=0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P=0.04 and 2.8 versus 0.4%, P=0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving ⩾VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCyclophosphamideDexamethasoneDoxorubicinFemaleFollow-Up StudiesHematopoietic Stem Cell MobilizationHumansInduction ChemotherapyMaleMiddle AgedMultiple MyelomaBoronic AcidsBortezomibCyclophosphamideDexamethasoneDoxorubicinPyrazines

Identifiers

PMID25787915
OpenAlexW2050829096

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.