Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma

NCT02861287 — Completed, 60 participants, Institut Paoli-Calmettes

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

RegistryNCT02861287, acronym PLERIXAFOR
StatusCompleted
Study typeObservational
Enrollment60 (Actual)
SponsorInstitut Paoli-Calmettes (Other)
ConditionsMultiple Myeloma
InterventionsEconomic evaluation (Other)
Datesstart 2015-01-01, primary completion 2015-12-01, first posted 2016-08-10, last updated 2016-08-10
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Economic evaluation

-Summary

This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Study cohortOther: Economic evaluationpatients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria
Historical cohortOther: Economic evaluationpatients with Multiple Myeloma who underwent PBSC mobilization immediately prior to marketing authorization and clinical utilization of Plerixafor which is before December 2009 (over the 2007-2009 period)
  • Economic evaluation (Other)

+Outcome measures

Primary outcomes

  • Cost-effectiveness analysis [1 year]: The cost-effectiveness analysis will be performed using the collection of a transplantable graft as effectiveness criteria; the suitability of collected cell products for transplantation will be judged as per institutional criteria. Direct medical costs will be estimated by micro-costing, i.e. by measuring physical quantities (capital and labor) consumed for each patient and attributing corresponding monetary costs on the basis of average French prices. Costs (including room - inpatient and outpatient, drugs and laboratory tests) will be estimated on the basis of patients' medical records.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patients diagnosed with Multiple Myeloma who were eligible for high-dose melphalan supported with autologous hematopoietic stem cell transplantation (HSCT) as part of their treatment plan
* First mobilization attempt
* "rhG-CSF alone" mobilization regimen
* Failed mobilization as documented by an increase in CD34+ cell mobilization deemed insufficient to initiate apheresis (below 15/µL), after the 4 first injections of rhG-CSF that are administered in the evening

Exclusion Criteria:

* Age < 18 years;
* Primary diagnosis other than MM
* 2nd or subsequent mobilization attempt
* Patients who previously received HDCT + autologous HSCT
* Chemotherapy-based mobilization regimen
* Efficient mobilization, allowing for apheresis and collection of the target cell number (5x106 CD34+ cells/kg for every planned autologous transplantation as per institutional SOPs).

+Locations (1)

FacilityCityCountryStatus
Institut Paoli-CalmettesMarseille, Bouches-du RhôneFrance

+Investigators