Clinical trial NCT02997813: Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies
Official title: Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Blood Stem Cell Transplant Failure
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
First posted: 2016-12-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Total cost of stem cell mobilization procedure (including remobilisation if applicable)
timeFrame: 2009-2013
Secondary outcomes:
measure: Number of visits for administration of mobilizing agents
timeFrame: 2009-2013
measure: Duration (days) of administration of mobilizing agents
timeFrame: 2009-2013
measure: Agents used as mobilizing agents
timeFrame: 2009-2013
measure: Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)
timeFrame: 2009-2013
measure: Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)
timeFrame: 2009-2013
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHRU Dijon
city: Limoges
country: France
facility: Centre Hospitalier Universitaire (CHU) de Limoges
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Nantes
country: France
facility: CHRU Hôtel Dieu
city: Paris
country: France
facility: Institut Curie Centre de Lutte Contre le Cancer (CLCC)
city: Paris
country: France
facility: La Pitié Salpetriêre
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Reims
country: France
facility: Hôpital Robert Debré Hématologie
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Service des maladies du sang, Hôpital Huriez, CHRU, Lille
name: Xavier Leleu, Dr
role: STUDY_CHAIR
affiliation: Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon
name: Denis Caillot, Dr
role: STUDY_DIRECTOR
affiliation: Hématologie, Hôpital Jean Minjoz, CHU Besançon
name: Eric Deconinck, Pr
role: STUDY_DIRECTOR
affiliation: Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon
name: Samuel Limat, Pr
role: STUDY_DIRECTOR
References: