Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy. All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included. All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.

Official Title
-----------------
Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor

Conditions
-----------------
Multiple Myeloma, Blood Stem Cell Transplant Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous hematopoietic stem cell transplantation (ASCT) upfront. Age > 18 years Undergone prior successful peripheral blood stem cell mobilization with Cyclophosphamid or Plerixafor Exclusion Criteria: Age < 18 years; Primary diagnosis other than Multiple Myeloma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor | |
| Cohort 2<br>All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cost of stem cell mobilization procedure (including remobilisation if applicable) |  | 2009-2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visits for administration of mobilizing agents |  | 2009-2013 | 
| Duration (days) of administration of mobilizing agents |  | 2009-2013 | 
| Agents used as mobilizing agents |  | 2009-2013 | 
| Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg) |  | 2009-2013 | 
| Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg) |  | 2009-2013 |