PMID- 23241739 OWN - NLM STAT- MEDLINE DCOM- 20140204 LR - 20220311 IS - 1476-5365 (Electronic) IS - 0268-3369 (Linking) VI - 48 IP - 7 DP - 2013 Jul TI - In a high-dose melphalan setting, palifermin compared with placebo had no effect on oral mucositis or related patient's burden. PG - 966-71 LID - 10.1038/bmt.2012.257 [doi] AB - 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 mug/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. FAU - Blijlevens, N AU - Blijlevens N AD - Department of Haematology, Radboud University Nijmegen Medical Centre, Nijmegen, Nijmegen, The Netherlands. n.blijlevens@hemat.umcn.nl FAU - de Chateau, M AU - de Chateau M FAU - Krivan, G AU - Krivan G FAU - Rabitsch, W AU - Rabitsch W FAU - Szomor, A AU - Szomor A FAU - Pytlik, R AU - Pytlik R FAU - Lissmats, A AU - Lissmats A FAU - Johnsen, H E AU - Johnsen HE FAU - de Witte, T AU - de Witte T FAU - Einsele, H AU - Einsele H FAU - Ruutu, T AU - Ruutu T FAU - Niederwieser, D AU - Niederwieser D CN - CLWP of the EBMT LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20121217 PL - England TA - Bone Marrow Transplant JT - Bone marrow transplantation JID - 8702459 RN - 0 (Myeloablative Agonists) RN - 126469-10-1 (Fibroblast Growth Factor 7) RN - Q41OR9510P (Melphalan) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Autografts MH - Female MH - Fibroblast Growth Factor 7/*administration & dosage/adverse effects MH - Follow-Up Studies MH - Humans MH - Male MH - Melphalan/*administration & dosage/adverse effects MH - Middle Aged MH - Multiple Myeloma/epidemiology/*therapy MH - Myeloablative Agonists MH - *Stem Cell Transplantation MH - Stomatitis/*epidemiology/etiology/prevention & control MH - *Transplantation Conditioning FIR - Angelucci, Emanuele IR - Angelucci E FIR - Benboubker, Lotfi IR - Benboubker L FIR - Blijlevens, Nicole IR - Blijlevens N FIR - Browne, Paul IR - Browne P FIR - Bourhis, Jean-Henri IR - Bourhis JH FIR - Bunjes, Donald IR - Bunjes D FIR - Carella, Angelo Michele IR - Carella AM FIR - Crawley, Charles IR - Crawley C FIR - Christiansen, Ilse IR - Christiansen I FIR - Clausen, Johannes IR - Clausen J FIR - Dreger, Peter IR - Dreger P FIR - Einsele, Hermann IR - Einsele H FIR - Cook, Gordon IR - Cook G FIR - Cook, Mark IR - Cook M FIR - Facon, Thierry IR - Facon T FIR - Fillitz, Michael IR - Fillitz M FIR - Garderet, Laurent IR - Garderet L FIR - Gratwohl, Alois IR - Gratwohl A FIR - Harrousseau, Jean Luc IR - Harrousseau JL FIR - Iacopino, Pasquale IR - Iacopino P FIR - Melacrino, A O IR - Melacrino AO FIR - Jebavy, Ladislav IR - Jebavy L FIR - Kralove, Hradec IR - Kralove H FIR - Johansson, Jan-Erik IR - Johansson JE FIR - Kasparu, Hedvig IR - Kasparu H FIR - Ketterer, Nicolas IR - Ketterer N FIR - Kienast, Joachim IR - Kienast J FIR - Kobbe, Guido IR - Kobbe G FIR - Krivan, Gergely IR - Krivan G FIR - Deliliers, Giorgio Lambertenghi IR - Deliliers GL FIR - Lemoli, Roberto M IR - Lemoli RM FIR - Linkesch, Werner IR - Linkesch W FIR - Losonczy, Hajna IR - Losonczy H FIR - Maertens, Johan IR - Maertens J FIR - Lutz, Dieter IR - Lutz D FIR - Meloni, Giovanna IR - Meloni G FIR - Masszi, Tamas IR - Masszi T FIR - Morgan, Gareth IR - Morgan G FIR - Niederwieser, Dietger IR - Niederwieser D FIR - Pytlik, Robert IR - Pytlik R FIR - Rabitsch, Werner IR - Rabitsch W FIR - Rahemtulla, Amin IR - Rahemtulla A FIR - Rossi, Jean-Francois IR - Rossi JF FIR - Russell, Nigel IR - Russell N FIR - Ruutu, Tapani IR - Ruutu T FIR - Saglio, Giuseppe IR - Saglio G FIR - Sonet, Ann IR - Sonet A FIR - Szomor, Arpad IR - Szomor A FIR - Van Droogenbroeck, Pecsi Hungary Jan IR - Van Droogenbroeck PH FIR - Zachee, Pierre IR - Zachee P EDAT- 2012/12/18 06:00 MHDA- 2014/02/05 06:00 CRDT- 2012/12/18 06:00 PHST- 2012/07/16 00:00 [received] PHST- 2012/11/09 00:00 [revised] PHST- 2012/11/13 00:00 [accepted] PHST- 2012/12/18 06:00 [entrez] PHST- 2012/12/18 06:00 [pubmed] PHST- 2014/02/05 06:00 [medline] AID - bmt2012257 [pii] AID - 10.1038/bmt.2012.257 [doi] PST - ppublish SO - Bone Marrow Transplant. 2013 Jul;48(7):966-71. doi: 10.1038/bmt.2012.257. Epub 2012 Dec 17.