A comparison of chemo-free strategy with G-CSF plus plerixafor on demand versus intermediate-dose cyclophosphamide and G-CSF as PBSC mobilization in newly diagnosed multiple myeloma patients: An Italian explorative cost Analysis.
chemo-free stem cell mobilization
multiple myeloma
plerixafor
Journal
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis
ISSN: 1473-0502
Titre abrégé: Transfus Apher Sci
Pays: England
ID NLM: 101095653
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
26
03
2020
revised:
06
05
2020
accepted:
07
05
2020
pubmed:
6
6
2020
medline:
7
8
2021
entrez:
6
6
2020
Statut:
ppublish
Résumé
Upfront single or tandem ASCT still represents an integral part of treatment for patients with multiple myeloma. The combination of intermediate dose (ID) - cyclophosphamide plus G-CSF, has been considered the standard method as mobilization regimen. No prospective randomized clinical trials have compared efficacy and costs using ID - cyclophosphamide against a chemo-free mobilization strategy with G-CSF and plerixafor on demand. A prospective single arm of 20 patients enrolled in three Italian Centers mobilized with G-CSF plus plerixafor on demand was compared with a retrospective historical control arm of 30 patients mobilized with ID - cyclophosphamide (4 g/sqm) and G-CSF. Costs of the prospective arm was compared with the ones of the retrospective control arm with the aim to collect ≥4 × 10 Mobilization with ID - cyclophosphamide and G-CSF resulted in a significantly higher CD34+ peak mean on day 1 yield (119 CD34+ μL vs 67.3; p = 0.06) and in total average CD34+ yield (mean collection 10.6 × 10 Our data demonstrate that in patients with multiple myeloma eligible for ASCT, a chemo-free mobilization with G-CSF and plerixafor on demand is associated with efficacy in PBSC collection and optimal safety profile with similar average costs when compared to a chemo-mobilization with ID - cyclophosphamide. A prospective randomized multicenter study could address which is the most cost-effective strategy for this setting of patients. Eudract Number EudraCT 2013-004690-27.
Sections du résumé
BACKGROUND
BACKGROUND
Upfront single or tandem ASCT still represents an integral part of treatment for patients with multiple myeloma. The combination of intermediate dose (ID) - cyclophosphamide plus G-CSF, has been considered the standard method as mobilization regimen. No prospective randomized clinical trials have compared efficacy and costs using ID - cyclophosphamide against a chemo-free mobilization strategy with G-CSF and plerixafor on demand.
METHODS
METHODS
A prospective single arm of 20 patients enrolled in three Italian Centers mobilized with G-CSF plus plerixafor on demand was compared with a retrospective historical control arm of 30 patients mobilized with ID - cyclophosphamide (4 g/sqm) and G-CSF. Costs of the prospective arm was compared with the ones of the retrospective control arm with the aim to collect ≥4 × 10
RESULTS
RESULTS
Mobilization with ID - cyclophosphamide and G-CSF resulted in a significantly higher CD34+ peak mean on day 1 yield (119 CD34+ μL vs 67.3; p = 0.06) and in total average CD34+ yield (mean collection 10.6 × 10
CONCLUSIONS
CONCLUSIONS
Our data demonstrate that in patients with multiple myeloma eligible for ASCT, a chemo-free mobilization with G-CSF and plerixafor on demand is associated with efficacy in PBSC collection and optimal safety profile with similar average costs when compared to a chemo-mobilization with ID - cyclophosphamide. A prospective randomized multicenter study could address which is the most cost-effective strategy for this setting of patients.
CLINICAL TRIAL REGISTRY
BACKGROUND
Eudract Number EudraCT 2013-004690-27.
Identifiants
pubmed: 32499108
pii: S1473-0502(20)30114-2
doi: 10.1016/j.transci.2020.102819
pii:
doi:
Substances chimiques
Benzylamines
0
Cyclams
0
Granulocyte Colony-Stimulating Factor
143011-72-7
Cyclophosphamide
8N3DW7272P
plerixafor
S915P5499N
Types de publication
Journal Article
Langues
eng
Pagination
102819Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.