Evidence map›Paper›PMID 34825942›Full record

Trial reportCancer chemotherapy and pharmacology2022

Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma.

Takafumi Ide, Mayu Osawa, Kinjal Sanghavi, Heather E Vezina

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

Trial report in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02654132 (An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

NCT02654132 phase2completednot on this map

An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2021Enrolled117ConditionsMultiple MyelomaArmsElotuzumab, Pomalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  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

4 authors at 2 institutions in 3 countries.

Takafumi IdeClinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA.
Mayu OsawaClinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA.
Kinjal SanghaviClinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA.
Heather E VezinaClinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA. Heather.Vezina@bms.com.ORCID http://orcid.org/0000-0002-0522-9264
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeElotuzumab plus pomalidomide/dexamethasone (E-Pd) demonstrated efficacy and safety in relapsed and refractory multiple myeloma (RRMM). The clinical pharmacology of elotuzumab [± lenalidomide/dexamethasone (Ld)] was characterized previously. These analyses describe elotuzumab population pharmacokinetics (PPK), the effect of Pd, and assess elotuzumab exposure-response relationships for efficacy and safety in patients with RRMM.

methodsA previously established PPK model was updated with E-Pd data from the phase 2 ELOQUENT-3 study (NCT02654132). The dataset included 8180 serum concentrations from 440 patients with RRMM from 5 clinical trials. Elotuzumab PK parameter estimates were used to generate individual daily time-varying average concentrations (daily C

resultsElotuzumab PK were well-described by a two-compartment model with parallel linear and Michaelis-Menten elimination from the central compartment (V

conclusionsThe PPK model adequately described the data and was appropriate for determining exposures for exposure-response analyses. There were no clinically relevant differences in elotuzumab exposures between Pd and Ld backbones. In ELOQUENT-3, increasing elotuzumab daily C

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleHumansMaleMiddle AgedMultiple MyelomaMyeloma ProteinsNeoplasm Recurrence, LocalProgression-Free SurvivalThalidomideTreatment OutcomeAntibodies, Monoclonal, HumanizedDexamethasoneelotuzumabmultiple myeloma M-proteinsMyeloma ProteinspomalidomideThalidomideElotuzumabMultiple myelomaPharmacokineticsProgression-free survivalSafety

Identifiers

PMID34825942
PMCPMC8739320
OpenAlexW3217063877

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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.