Evidence map›Paper›PMID 37316728›Full record

ArticleLeukemia2023

Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation.

Enrique M Ocio, Aurore Perrot, Pierre Bories, Jesus F San-Miguel, Igor W Blau, Lionel Karlin, Joaquin Martinez-Lopez, Song-Yau Wang, Sara Bringhen, Magda Marcatti and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Leukemia, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02513186 (A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
7.0field-weighted citation impact, top 3% 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.

NCT02513186 phase1completednot on this map

A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation

TypeinterventionalSponsorSanofiRan2015 to 2024Enrolled90ConditionsPlasma Cell MyelomaArmslenalidomide, bortezomib, cyclophosphamide, dexamethasone, isatuximab SAR650984
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 24 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

21 authors at 14 institutions in 6 countries.

Enrique M OcioUniversity Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria, Santander, Spain. ocioem@unican.es.ORCID http://orcid.org/0000-0002-5765-0085
Aurore PerrotCHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie, Toulouse, France.ORCID http://orcid.org/0000-0003-0131-8689
Pierre BoriesToulouse University Institute of Cancer-Oncopole, Toulouse, France.
Jesus F San-MiguelClinica Universidad de Navarra, CCUN, CIMA, IDISNA, CIBERONC, Pamplona, Spain.ORCID http://orcid.org/0000-0002-9183-4857
Igor W BlauCharité Medical University, Berlin, Germany.
Lionel KarlinHôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
Joaquin Martinez-LopezHospital 12 de Octubre, Complutense University, CNIO, Madrid, Spain.
Song-Yau WangDepartment of Hematology and Oncology, University of Leipzig, Leipzig, Germany.
Sara BringhenSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.ORCID http://orcid.org/0000-0003-4539-6363
Magda MarcattiVita-Salute San Raffaele University, Milan, Italy.
María-Victoria MateosUniversity Hospital of Salamanca, IBSAL, CSIC/CIC, Salamanca, Spain.ORCID http://orcid.org/0000-0003-2390-1218
Paula Rodriguez-OteroClinica Universidad de Navarra, CCUN, CIMA, IDISNA, CIBERONC, Pamplona, Spain.ORCID http://orcid.org/0000-0001-5236-7785
Stefania OlivaDipartimento di Oncologia ed Ematologia SC Ematologia 1 U, Torino, Italy.ORCID http://orcid.org/0000-0002-3084-180X
Axel NogaiCharité Medical University, Berlin, Germany.
Nadia Le RouxSanofi Research & Development on behalf of Altran, Vitry-sur-Seine, France.
Liyan DongSanofi, Beijing, China.
Sandrine MacéSanofi Translational Medicine, Chilly-Mazarin, France.
Matthieu GassiotSanofi Research & Development on behalf of Excelya, Montpellier, France.
Thomas FitzmauriceSanofi, Cambridge, MA, USA.
Corina OpreaSanofi Oncology, Vitry-sur-Seine, France.
Philippe MoreauUniversity of Nantes, Nantes, France.ORCID http://orcid.org/0000-0003-1780-8746
Sanofi (France) · FRCharité - Universitätsmedizin Berlin · DEClinica Universidad de Navarra · ESAltran (France) · FRAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITHospices Civils de Lyon · FRInstituto de Investigación Biomédica de Salamanca · ESInstitut universitaire du cancer de Toulouse Oncopole · FRNantes Université · FRSanofi (China) · CNSanofi (United States) · USUniversidad de Cantabria · ESUniversité Toulouse III - Paul Sabatier · FRVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab, an anti-CD38 monoclonal antibody, combined with bortezomib-lenalidomide-dexamethasone (Isa-VRd) in patients with NDMM ineligible for/with no intent for immediate ASCT. Overall, 73 patients received four 6-week induction cycles of Isa-VRd, then maintenance with Isa-Rd in 4-week cycles. In the efficacy population (n = 71), the overall response rate was 98.6%, with 56.3% achieving a complete response or better (sCR/CR), and 36/71 (50.7%) patients reaching minimal residual disease negativity (10

Indexed as

Hematopoietic Stem Cell TransplantationMultiple MyelomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneHumansLenalidomideTransplantation, AutologousAntibodies, Monoclonal, HumanizedBortezomibDexamethasoneisatuximabLenalidomide

Identifiers

PMID37316728
PMCPMC10264885
OpenAlexW4380682702

What OpenQuestion holds

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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.