Evidence map›Paper›PMID 39607833›Full record

ArticleCPT: pharmacometrics & systems pharmacology2024

Isatuximab-dexamethasone-pomalidomide combination effects on serum M protein and PFS in myeloma: Development of a joint model using phase I/II data.

Antoine Pitoy, Solène Desmée, François Riglet, Hoai-Thu Thai, Zandra Klippel, Dorothée Semiond, Christine Veyrat-Follet, Julie Bertrand

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. Article
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

8 authors.

Antoine PitoySanofi Data and Data Sciences, Translational Disease Modeling, Gentilly, France.ORCID 0000-0003-0428-2300
Solène DesméeINSERM, SPHERE, U1246, Tours University, Nantes University, Tours, France.
François RigletSanofi Data and Data Sciences, Translational Disease Modeling, Gentilly, France.
Hoai-Thu ThaiSanofi Data and Data Sciences, Translational Disease Modeling, Gentilly, France.ORCID 0000-0002-5239-6399
Zandra KlippelSanofi Translational Medicine and Early Development, Cambridge, Massachusetts, USA.
Dorothée SemiondSanofi Translational Medicine and Early Development, Cambridge, Massachusetts, USA.
Christine Veyrat-FolletSanofi Data and Data Sciences, Translational Disease Modeling, Gentilly, France.ORCID 0009-0000-9865-8959
Julie BertrandINSERM, IAME, Université Paris Cité, Paris, France.ORCID 0000-0002-6568-1041

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed at leveraging data from phase I/II clinical trials to build a nonlinear joint model of serum M-protein kinetics and progression-free survival (PFS) accounting for the effects of isatuximab (Isa), pomalidomide (Pom), and dexamethasone (Dex) in patients with relapsed and/or refractory multiple myeloma. Serum M-protein levels and PFS data from 203 evaluable patients, included either in a phase I/II study (n = 173) or in a phase I study (n = 30), were used to build the model. First, we independently developed a longitudinal model and a PFS model. Then, we linked them in a nonlinear joint model by selecting the link function that best captured the association between serum M-protein kinetics and PFS. A Claret tumor growth-inhibition model accounting for the additive effects of Isa, with an E

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneMultiple MyelomaProgression-Free SurvivalThalidomideAdultAgedAged, 80 and overClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedModels, BiologicalAntibodies, Monoclonal, HumanizedDexamethasoneisatuximabmultiple myeloma M-proteinsMyeloma ProteinspomalidomideThalidomide

Identifiers

PMID39607833
PMCPMC11646945

What OpenQuestion holds

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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.