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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Economic evaluation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br>patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria | Other: Economic evaluation<br> <br> |
| Historical cohort<br>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) | Other: Economic evaluation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness analysis | 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. | 1 year |