Evidence map›Paper›PMID 28160288›Full record

Trial reportClinical pharmacology and therapeutics2017

Associations of High-Dose Melphalan Pharmacokinetics and Outcomes in the Setting of a Randomized Cryotherapy Trial.

Y K Cho, D W Sborov, M Lamprecht, J Li, J Wang, E M Hade, Y Gao, K Tackett, N Williams, D M Benson and 6 more

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Systematic review of oral cryotherapy for the management of oral mucositis in cancer patients and clinical practice guidelines.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  3. Cryopreventive temperatures prior to chemotherapy.Medical oncology (Northwood, London, England) · 2023
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Optimizing high dose melphalan.Blood reviews · 2024
    Review
  12. Article
  13. Toxicity assessment of concurrent gabapentin/pregabalin administration with high-dose melphalan in autologous hematopoietic cell transplant recipients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. 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

16 authors.

Y K ChoDivision of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.
D W SborovDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
M LamprechtWexner Medical Center, The Ohio State University, Columbus, Ohio, USA.
J LiDivision of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.
J WangComprehensive Cancer Center, The Ohio State University, Columbus, Ohio, USA.
E M HadeCenter for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio, USA.
Y GaoDivision of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.
K TackettWexner Medical Center, The Ohio State University, Columbus, Ohio, USA.
N WilliamsDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
D M BensonDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
Y A EfeberaDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
A E RoskoDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
S M DevineDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
M PoiDivision of Pharmacy Practice and Science, College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.
C C HofmeisterDivision of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio, USA.
M A PhelpsDivision of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

High-dose melphalan followed by autologous stem cell transplantation remains the standard of care for eligible patients with multiple myeloma, but disease response and toxicity, including severe mucositis, varies among patients. Our randomized trial investigated duration of cryotherapy (2 and 6 h) for reduction of mucositis prevalence and severity and explored factors associated with variability in pharmacokinetics and outcomes from melphalan therapy. The results demonstrate that 2-h is at least as effective as 6-h cryotherapy in decreasing severe mucositis. From a population pharmacokinetic model, we identified that fat-free mass, hematocrit, and creatinine clearance were significant covariates, as reported previously. Furthermore, we observed the rs4240803 SLC7A5 polymorphism was significantly associated with pharmacokinetic variability, and pharmacokinetics was associated with both mucositis and neutropenia. However, melphalan exposure was not associated with progression-free or overall survival in our dataset. These findings contribute to ongoing efforts to personalize melphalan dosing in transplant patients.

Indexed as

AdultAgedAntineoplastic Agents, AlkylatingCombined Modality TherapyCreatinineCryotherapyDisease-Free SurvivalDose-Response Relationship, DrugFemaleHematopoietic Stem Cell TransplantationHumansLarge Neutral Amino Acid-Transporter 1MaleMelphalanMiddle AgedMultiple MyelomaAntineoplastic Agents, AlkylatingCreatinineLarge Neutral Amino Acid-Transporter 1Melphalan

Identifiers

PMID28160288
PMCPMC5821248

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.