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

Multiple Myeloma Clinical Trial

— MOZOBIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997813
• Other study ID #: IFM2014-05
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: December 16, 2016
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Intergroupe Francophone du Myelome
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Stem Cell Transplant Failure
• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
France	CHRU Dijon	Dijon
France	Centre Hospitalier Universitaire (CHU) de Limoges	Limoges
France	Centre Hospitalier Lyon Sud	Lyon
France	CHRU Hôtel Dieu	Nantes
France	Hôpital Saint-Antoine	Paris
France	Institut Curie Centre de Lutte Contre le Cancer (CLCC)	Paris
France	La Pitié Salpetriêre	Paris
France	Hôpital Robert Debré Hématologie	Reims
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone du Myelome

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cost of stem cell mobilization procedure (including remobilisation if applicable)		2009-2013	No
Secondary	Number of visits for administration of mobilizing agents		2009-2013	No
Secondary	Duration (days) of administration of mobilizing agents		2009-2013	No
Secondary	Agents used as mobilizing agents		2009-2013	No
Secondary	Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)		2009-2013	No
Secondary	Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)		2009-2013	No