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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02861287
Other study ID # PLERIXAFOR-IPC 2013-002
Secondary ID
Status Completed
Phase N/A
First received August 5, 2016
Last updated August 5, 2016
Start date January 2015

Study information

Verified date August 2016
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Economic evaluation


Locations

Country Name City State
France Institut Paoli-Calmettes Marseille Bouches-du Rhône

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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