Trial reportBone marrow transplantation2013
In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient's burden.
Trial report in Bone marrow transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Systematic review of growth factors and cytokines 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 · 2020Pooled it
- Comparative efficacy and safety of interventions for preventing chemotherapy-induced oral mucositis in adult cancer patients: a systematic review and network meta-analysis.European journal of hospital pharmacy : science and practice · 2020Pooled it
- Prevention and Treatment of Chemotherapy and Radiotherapy Induced Oral Mucositis.Medicina (Kaunas, Lithuania) · 2019Pooled it
- Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial.BMC medicine · 2022Trial
- Associations of High-Dose Melphalan Pharmacokinetics and Outcomes in the Setting of a Randomized Cryotherapy Trial.Clinical pharmacology and therapeutics · 2017Trial
- Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: a randomised, double-blind, prospective pilot study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Trial
- Trial
- Cryotherapy reduces oral mucositis and febrile episodes in myeloma patients treated with high-dose melphalan and autologous stem cell transplant: a prospective, randomized study.Bone marrow transplantation · 2017Trial
- Oral mucositis management in hematopoietic cell transplantation in Australia and New Zealand (CAN EAT Survey).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate E-Selectin Inhibition with Uproleselan to Reduce Gastrointestinal Toxicity During Autologous Hematopoietic Cell Transplantation for Multiple Myeloma.Transplantation and cellular therapy · 2026Article
- Gold nanoparticles as innovative therapeutics for oral mucositis: A review of current evidence.Drug delivery and translational research · 2025Review
- Optimizing high dose melphalan.Blood reviews · 2024Review
- Interventions for the Prevention of Oral Mucositis in Patients Receiving Cancer Treatment: Evidence from Randomised Controlled Trials.Current oncology (Toronto, Ont.) · 2023Review
- Translational model of melphalan-induced gut toxicity reveals drug-host-microbe interactions that drive tissue injury and fever.Cancer chemotherapy and pharmacology · 2021Article
- Article
- Burden of oral mucositis in stem cell transplant patients-the patients' perspective.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Article
- Efficacy of palifermin on oral mucositis and acute GVHD after hematopoietic stem cell transplantation (HSCT) in hematology malignancy patients: a meta-analysis of trials.Contemporary oncology (Poznan, Poland) · 2017Article
- Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma.Bone marrow transplantation · 2016Review
- Management of Mucositis During Chemotherapy: From Pathophysiology to Pragmatic Therapeutics.Current oncology reports · 2015Review
- Palifermin reduces infection rate and hyperfibrinogenemia in patients treated with high-dose chemotherapy based on beam or BU-thiothepa.Bone marrow transplantation · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 11 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This randomized-controlled trial studied the efficacy of palifermin in a chemotherapy-only, high-dose Melphalan (HDM) transplant setting, to reduce oral mucositis (OM) and its sequelae measured by patient-reported outcomes (PRO) and medical resource use. Palifermin, relative to placebo was given either pre-/post-HDM or pre-HDM in patients with multiple myeloma (MM) undergoing auto-SCT at 39 European centers. Oral cavity assessment (WHO) and PRO questionnaires (oral mucositis daily questionnaire (OMDQ) and EQ 5D) were used in 281 patients (mean age 56, ± s.d.=8 years). 57 patients received placebo. One hundred and fifteen subjects were randomized to pre-/post-HDM receiving palifermin on 3 consecutive days before HDM and after auto-SCT and 109 patients were randomized to pre-HDM, receiving palifermin (60 μg/kg/day) i.v. for 3 consecutive days before HDM. There was no statistically significant difference in maximum OM severity. Severe OM occurred in 37% (placebo), 38% (pre-/post-HDM) and 24% (pre-HDM) of patients. No significant difference was observed with respect to PRO assessments or medical resource use, but more infections and fever during neutropenia were reported in pre-/post-HDM vs placebo (for example, 51 and 26%). To conclude, palifermin was unable to reduce OM or OM-related patient's burden in MM transplant patients.
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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.