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

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: Economic evaluation

• Registration Number: NCT02861287
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	Economic evaluation	patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria
Historical cohort	Economic evaluation	patients 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)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, Bouches-du Rhône, France