Evidence map›Paper›PMID 36205743›Full record

ArticleEuropean journal of clinical pharmacology2022

Challenges associated with test dose pharmacokinetic predictions of high dose melphalan exposure in patients with multiple myeloma.

Christa Ellen Nath, Andrew Grigg, Sebastian P A Rosser, Jane Estell, Elizabeth Newman, Campbell Tiley, Sundra Ramanathan, Shir Jing Ho, Stephen Larsen, John Gibson and 3 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 79% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. 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

13 authors at 8 institutions in 1 country.

Christa Ellen NathBiochemistry Department, The Children's Hospital at Westmead, Westmead, Australia. christa.nath@health.nsw.gov.au.ORCID http://orcid.org/0000-0002-1013-3646
Andrew GriggClinical Haematology Department, Austin Hospital, Heidelberg, Australia.
Sebastian P A RosserBiochemistry Department, The Children's Hospital at Westmead, Westmead, Australia.ORCID http://orcid.org/0000-0002-0203-4904
Jane EstellHaematology Department, Concord Repatriation General Hospital, Concord, Australia.
Elizabeth NewmanHaematology Department, Concord Repatriation General Hospital, Concord, Australia.
Campbell TileyHaematology Department, Gosford Hospital, Gosford, Australia.
Sundra RamanathanHaematology Department, St George Hospital, Kogarah, Australia.
Shir Jing HoHaematology Department, St George Hospital, Kogarah, Australia.ORCID http://orcid.org/0000-0002-5368-8975
Stephen LarsenHaematology Department, Royal Prince Alfred Hospital, Camperdown, Australia.
John GibsonHaematology Department, Royal Prince Alfred Hospital, Camperdown, Australia.
Peter PresgraveHaematology Department, Wollongong Hospital, Wollongong, Australia.
Peter John ShawCancer Centre for Children, The Children's Hospital at Westmead, Westmead, Australia.
Judith TrotmanHaematology Department, Concord Repatriation General Hospital, Concord, Australia.
The University of Sydney · AUAustin Hospital · AUChildren's Hospital at Westmead · AUConcord Repatriation General Hospital · AUGosford Hospital · AUSt George Hospital · AUUNSW Sydney · AUWollongong Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the accuracy of melphalan test dose pharmacokinetic (PK) predictions of the subsequent high dose (HDM) area under the concentration-versus-time curve (AUC) and to identify sources of prediction error (PE).

methodsA prospective multicentre PK study was conducted in 40 myeloma patients of median age 60 (range:35-71) years using a 20 mg/m

resultsPredicted HDM AUC was within 15% of the observed values in only 63% of patients when analysed using the trapezoidal rule and 70% of patients using PopPK. Test dose infusion concentration, volume, duration and time from preparation to infusion were significantly lower than for HDM (p < 0.005). Test dose administration within 15 min of reconstitution (n = 5) was associated with significantly lower PE than administration times of 16-60 min (n = 22), p < 0.05. Test and HDM infusion concentrations were lower in patients with large PE (> ± 15%), but the differences were not significant (p = 0.078, 0.228, respectively).

conclusionTest dose PK has the potential to predict subsequent HDM exposure to achieve a target AUC once melphalan administration parameters are optimised to account for stability issues in the formulation.

Indexed as

Hematopoietic Stem Cell TransplantationMultiple MyelomaArea Under CurveHumansMelphalanMiddle AgedProspective StudiesMelphalanMelphalanMyelomaPharmacokinetic predictionsTest dose

Identifiers

PMID36205743
PMCPMC9649448
OpenAlexW4303433006

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.