- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02861287
Economic Evaluation of the Use of Plerixafor for Autologous HSC Transplantation for Multiple Myeloma (PLERIXAFOR)
Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bouches-du Rhône
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Marseille, Bouches-du Rhône, France, 13009
- Institut Paoli-Calmettes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Study cohort
patients with Multiple Myeloma who underwent PBSC mobilization since December 2009 and who received plerixafor in line with inclusion criteria
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Historical cohort
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness analysis
Time Frame: 1 year
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Chabannon, MD PhD, Institut Paoli-Calmettes
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- PLERIXAFOR-IPC 2013-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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